Comparative Study on the Effectiveness, Comfort and Compliance of HFNC and Noninvasive Mechanical Ventilation BiPAP Mode in the Treatment of Hypoxemia Patients

Comparative Study on the Effectiveness, Comfort and Compliance of High-flow Nasal Oxygen Therapy and Noninvasive Mechanical Ventilation BiPAP Mode in the Treatment of Hypoxemia Patients

Patients who met the inclusion criteria were included and signed an informed consent form, which complied with the requirements of the ethics committee of our unit. All subjects were inpatients. Subjects were randomized into two groups. patients in group A were first treated with HFNC on top of conventional treatment, and after 24 hours, patients were treated with non-invasive ventilator-assisted ventilation BiPAP mode until discharge. patients in group B were treated with a non-invasive ventilator on top of conventional treatment, and after 24 hours of treatment, patients were treated with HFNC until discharge. Patient information was collected during treatment.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypoxemia
• Intervention / Treatment: Device: Non-invasive BiPAP ventilation; Device: HFNC

Detailed Description

Patients who met the inclusion criteria were included and signed the informed consent, which met the requirements of the ethics committee of our unit. All subjects were hospitalized patients. Subjects were randomly divided into two groups. Patients in group A were treated with HFNC on the basis of conventional treatment. The initial parameters were: temperature:31-37℃, flow: 30-40l /min, SpO2 > 92% maintained, the oxygen concentration was adjusted according to the patient's oxygen saturation, and the treatment time was 24h. Twenty-four hours later, the patients were treated with non-invasive ventilator-assisted ventilation BiPAP mode until discharge. On the basis of conventional treatment, patients in group B were given a non-invasive ventilator with the following initial parameters: BiPaP mode, initial inspiratory pressure (IPAP) of 8-15cmH2O, initial expiratory pressure (EPAP) of 4-8cmH2O. The parameters were adjusted according to the specific conditions of the patients. After 24 hours of treatment, the patient was treated with HFNC until discharge. Patient information was collected during treatment.

• Study Type: Interventional
• Enrollment (Anticipated): 243
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dedong Ma, MD; Phone Number: 18560082806; Email: ma@qiluhuxi.com
• Study Contact Backup: Name: chunwei He, master; Phone Number: 17361616499; Email: hechw160814@163.com

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250012
      • Qilu Hospital of Shandong University
      • Contact: Dedong Ma, MD; Phone Number: 18560082806; Email: ma@qiluhuxi.com
      • Contact: Chunwei He, MBBS; Phone Number: 17361616499; Email: hechw160814@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. . PaO2 < 60mmHg, SpO2 < 92%(without oxygen inhalation);
2. Mild to moderate type I respiratory failure (100 mmHg < PaO/Fi02≤300 mmHg);

Exclusion Criteria:

1. Missing primary outcome measures
2. Terminal stage of various chronic diseases;
3. The patient or family members do not agree to NIV or HFNI treatment;
4. Severe type I respiratory failure (PaO2/Fi02≤100 mmHg)
5. Ventilation dysfunction (pH<7.30)
6. Contradictory breathing
7. The patient abandons or terminates treatment, automatically discharges or transfers to another hospital;
8. Serious diseases, such as organ function damage and sepsis;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Non-invasive BiPAP ventilation treatment group; Patients were first treated with HFNC on the basis of conventional treatment. The initial parameters were temperature: 31-37 °C, flow rate: 30-40 L/min, maintaining SpO2>92%, adjusting oxygen concentration according to blood oxygen saturation, and treatment duration was 24 h. After 24 h, patients were treated with non-invasive ventilator-assisted ventilation BiPAP mode until discharge	Device: Non-invasive BiPAP ventilation; Patients were first treated with HFNC (High-flow nasal cannula) on the basis of conventional treatment. The initial parameters were temperature: 31-37 °C, flow rate: 30-40l /min, maintaining SpO2>92%, adjusting oxygen concentration according to blood oxygen saturation, and treatment duration was 24 h. After 24 h, patients were treated with non-invasive ventilator-assisted ventilation BiPAP mode until discharge.; Other Names: HFNC; Device: HFNC; On the basis of conventional treatment, patients were first administered a noninvasive ventilator with the following initial parameters. BiPAP mode with an initial inspiratory pressure (IPAP) of 8-15 cmH2O and an initial expiratory pressure (EPAP) of 4-8 cmH2O. These parameters were adjusted according to the patient's specific conditions. After 24 hours of treatment, patients received HFNC (High-flow nasal cannula) until discharge.; Other Names: Non-invasive BiPAP ventilation
Experimental: HFNC treatment group; On the basis of conventional treatment, patients were first administered a noninvasive ventilator with the following initial parameters. BiPAP mode with an initial inspiratory pressure (IPAP) of 8-15 cmH2O and an initial expiratory pressure (EPAP) of 4-8 cmH2O. These parameters were adjusted according to the patient's specific conditions. After 24 hours of treatment, patients received HFNC until discharge.	Device: Non-invasive BiPAP ventilation; Patients were first treated with HFNC (High-flow nasal cannula) on the basis of conventional treatment. The initial parameters were temperature: 31-37 °C, flow rate: 30-40l /min, maintaining SpO2>92%, adjusting oxygen concentration according to blood oxygen saturation, and treatment duration was 24 h. After 24 h, patients were treated with non-invasive ventilator-assisted ventilation BiPAP mode until discharge.; Other Names: HFNC; Device: HFNC; On the basis of conventional treatment, patients were first administered a noninvasive ventilator with the following initial parameters. BiPAP mode with an initial inspiratory pressure (IPAP) of 8-15 cmH2O and an initial expiratory pressure (EPAP) of 4-8 cmH2O. These parameters were adjusted according to the patient's specific conditions. After 24 hours of treatment, patients received HFNC (High-flow nasal cannula) until discharge.; Other Names: Non-invasive BiPAP ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HR	Heart rate	At the time of enrollment in the clinical study
HR	Heart rate	On the first hour after enrollment
HR	Heart rate	On the second hour after enrollment
HR	Heart rate	On the 6th hour after enrollment
HR	Heart rate	On the 12th hour after enrollment
HR	Heart rate	On the 24th hour after enrollment
HR	Heart rate	On the 25th hour after enrollment (On the first hour after crossover)
HR	Heart rate	On the 26th hour after enrollment (On the second hour after crossover)
HR	Heart rate	On the 30th hour after enrollment (On the 6th hour after crossover)
HR	Heart rate	On the 36th hour after enrollment (On the 12th hour after crossover)
HR	Heart rate	On the 48th hour after enrollment (On the 24th hour after crossover)
HR	Heart rate	On the third day after enrollment (On the 48th hour after crossover)
HR	Heart rate	On the 4th day after enrollment (On the third day after crossover)
HR	Heart rate	On the 5th day after enrollment (On the 4th day after crossover)
HR	Heart rate	On the 6th day after enrollment (On the 5th day after crossover)
HR	Heart rate	On the 7th day after enrollment (On the 6th day after crossover)
HR	Heart rate	On the 8th day after enrollment (On the 7th day after crossover)
HR	Heart rate	On the 9th day after enrollment (On the 8th day after crossover)
RR	Respiratory rate	At the time of enrollment in the clinical study
RR	Respiratory rate	On the first hour after enrollment
RR	Respiratory rate	On the second hour after enrollment
RR	Respiratory rate	On the 6th hour after enrollment
RR	Respiratory rate	On the 12th hour after enrollment
RR	Respiratory rate	On the 24th hour after enrollment
RR	Respiratory rate	On the 25th hour after enrollment (On the first hour after crossover)
RR	Respiratory rate	On the 26th hour after enrollment (On the second hour after crossover)
RR	Respiratory rate	On the 30th hour after enrollment (On the 6th hour after crossover)
RR	Respiratory rate	On the 36th hour after enrollment (On the 12th hour after crossover)
RR	Respiratory rate	On the 48th hour after enrollment (On the 24th hour after crossover)
RR	Respiratory rate	On the third day after enrollment (On the 48th hour after crossover)
RR	Respiratory rate	On the 4th day after enrollment (On the third day after crossover)
RR	Respiratory rate	On the 5th day after enrollment (On the 4th day after crossover)
RR	Respiratory rate	On the 6th day after enrollment (On the 5th day after crossover)
RR	Respiratory rate	On the 7th day after enrollment (On the 6th day after crossover)
RR	Respiratory rate	On the 8th day after enrollment (On the 7th day after crossover)
RR	Respiratory rate	On the 9th day after enrollment (On the 8th day after crossover)
BP	Blood pressure (Includes systolic and diastolic blood pressure)	At the time of enrollment in the clinical study
BP	Blood pressure (Includes systolic and diastolic blood pressure)	On the first hour after enrollment
BP	Blood pressure (Includes systolic and diastolic blood pressure)	On the second hour after enrollment
BP	Blood pressure (Includes systolic and diastolic blood pressure)	On the 6th hour after enrollment
BP	Blood pressure (Includes systolic and diastolic blood pressure)	On the 12th hour after enrollment
BP	Blood pressure (Includes systolic and diastolic blood pressure)	On the 24th hour after enrollment
BP	Blood pressure (Includes systolic and diastolic blood pressure)	On the 25th hour after enrollment (On the first hour after crossover)
BP	Blood pressure (Includes systolic and diastolic blood pressure)	On the 26th hour after enrollment (On the second hour after crossover)
BP	Blood pressure (Includes systolic and diastolic blood pressure)	On the 30th hour after enrollment (On the 6th hour after crossover)
BP	Blood pressure (Includes systolic and diastolic blood pressure)	On the 36th hour after enrollment (On the 12th hour after crossover)
BP	Blood pressure (Includes systolic and diastolic blood pressure)	On the 48th hour after enrollment (On the 24th hour after crossover)
BP	Blood pressure (Includes systolic and diastolic blood pressure)	On the third day after enrollment (On the 48th hour after crossover)
BP	Blood pressure (Includes systolic and diastolic blood pressure)	On the 4th day after enrollment (On the third day after crossover)
BP	Blood pressure (Includes systolic and diastolic blood pressure)	On the 5th day after enrollment (On the 4th day after crossover)
BP	Blood pressure (Includes systolic and diastolic blood pressure)	On the 6th day after enrollment (On the 5th day after crossover)
BP	Blood pressure (Includes systolic and diastolic blood pressure)	On the 7th day after enrollment (On the 6th day after crossover)
BP	Blood pressure (Includes systolic and diastolic blood pressure)	On the 8th day after enrollment (On the 7th day after crossover)
BP	Blood pressure (Includes systolic and diastolic blood pressure)	On the 9th day after enrollment (On the 8th day after crossover)
SO2	Pulse oxygen saturation	At the time of enrollment in the clinical study
SO2	Pulse oxygen saturation	On the first hour after enrollment
SO2	Pulse oxygen saturation	On the second hour after enrollment
SO2	Pulse oxygen saturation	On the 6th hour after enrollment
SO2	Pulse oxygen saturation	On the 12th hour after enrollment
SO2	Pulse oxygen saturation	On the 24th hour after enrollment
SO2	Pulse oxygen saturation	On the 25th hour after enrollment (On the first hour after crossover)
SO2	Pulse oxygen saturation	On the 26th hour after enrollment (On the second hour after crossover)
SO2	Pulse oxygen saturation	On the 30th hour after enrollment (On the 6th hour after crossover)
SO2	Pulse oxygen saturation	On the 36th hour after enrollment (On the 12th hour after crossover)
SO2	Pulse oxygen saturation	On the 48th hour after enrollment (On the 24th hour after crossover)
SO2	Pulse oxygen saturation	On the third day after enrollment (On the 48th hour after crossover)
SO2	Pulse oxygen saturation	On the 4th day after enrollment (On the third day after crossover)
SO2	Pulse oxygen saturation	On the 5th day after enrollment (On the 4th day after crossover)
SO2	Pulse oxygen saturation	On the 6th day after enrollment (On the 5th day after crossover)
SO2	Pulse oxygen saturation	On the 7th day after enrollment (On the 6th day after crossover)
SO2	Pulse oxygen saturation	On the 8th day after enrollment (On the 7th day after crossover)
SO2	Pulse oxygen saturation	On the 9th day after enrollment (On the 8th day after crossover)
pH	Degree of pH in arterial blood	At the time of enrollment in the clinical study
pH	Degree of pH in arterial blood	On the 24th hour after enrollment
pH	Degree of pH in arterial blood	On the 48th hour after enrollment (On the 24th hour after crossover)
pH	Degree of pH in arterial blood	On the third day after enrollment (On the 48th hour after crossover)
pH	Degree of pH in arterial blood	On the 4th day after enrollment (On the 3th day after crossover)
pH	Degree of pH in arterial blood	On the 5th day after enrollment (On the 4th day after crossover)
pH	Degree of pH in arterial blood	On the 6th day after enrollment (On the 5th day after crossover)
pH	Degree of pH in arterial blood	On the 7th day after enrollment (On the 6th day after crossover)
pH	Degree of pH in arterial blood	On the 8th day after enrollment (On the 7th day after crossover)
pH	Degree of pH in arterial blood	On the 9th day after enrollment (On the 8th day after crossover)
PaO2	Partial arterial oxygen pressure	At the time of enrollment in the clinical study
PaO2	Partial arterial oxygen pressure	On the 24th hour after enrollment
PaO2	Partial arterial oxygen pressure	On the 48th hour after enrollment (On the 24th hour after crossover)
PaO2	Partial arterial oxygen pressure	On the third day after enrollment (On the 48th hour after crossover)
PaO2	Partial arterial oxygen pressure	On the 4th day after enrollment (On the 3th day after crossover)
PaO2	Partial arterial oxygen pressure	On the 5th day after enrollment (On the 4th day after crossover)
PaO2	Partial arterial oxygen pressure	On the 6th day after enrollment (On the 5th day after crossover)
PaO2	Partial arterial oxygen pressure	On the 7th day after enrollment (On the 6th day after crossover)
PaO2	Partial arterial oxygen pressure	On the 8th day after enrollment (On the 7th day after crossover)
PaO2	Partial arterial oxygen pressure	On the 9th day after enrollment (On the 8th day after crossover)
SaO2	Arterial oxygen saturation	At the time of enrollment in the clinical study
SaO2	Arterial oxygen saturation	On the 24th hour after enrollment
SaO2	Arterial oxygen saturation	On the 48th hour after enrollment (On the 24th hour after crossover)
SaO2	Arterial oxygen saturation	On the third day after enrollment (On the 48th hour after crossover)
SaO2	Arterial oxygen saturation	On the 4th day after enrollment (On the third day after crossover)
SaO2	Arterial oxygen saturation	On the 5th day after enrollment (On the 4th day after crossover)
SaO2	Arterial oxygen saturation	On the 6th day after enrollment (On the 5th day after crossover)
SaO2	Arterial oxygen saturation	On the 7th day after enrollment (On the 6th day after crossover)
SaO2	Arterial oxygen saturation	On the 8th day after enrollment (On the 7th day after crossover)
SaO2	Arterial oxygen saturation	On the 9th day after enrollment (On the 8th day after crossover)
PCO2	partial pressure of carbon dioxide in arterial blood	At the time of enrollment in the clinical study
PCO2	partial pressure of carbon dioxide in arterial blood	On the 24th hour after enrollment
PCO2	partial pressure of carbon dioxide in arterial blood	On the 48th hour after enrollment (On the 24th hour after crossover)
PCO2	partial pressure of carbon dioxide in arterial blood	On the third day after enrollment (On the 48th hour after crossover)
PCO2	partial pressure of carbon dioxide in arterial blood	On the 4th day after enrollment (On the third day after crossover)
PCO2	partial pressure of carbon dioxide in arterial blood	On the 5th day after enrollment (On the 4th day after crossover)
PCO2	partial pressure of carbon dioxide in arterial blood	On the 6th day after enrollment (On the 5th day after crossover)
PCO2	partial pressure of carbon dioxide in arterial blood	On the 7th day after enrollment (On the 6th day after crossover)
PCO2	partial pressure of carbon dioxide in arterial blood	On the 8th day after enrollment (On the 7th day after crossover)
PCO2	partial pressure of carbon dioxide in arterial blood	On the 9th day after enrollment (On the 8th day after crossover)
FiO2	Fraction of inspiration O2	At the time of enrollment in the clinical study
FiO2	Fraction of inspiration O2	On the 24th hour after enrollment
FiO2	Fraction of inspiration O2	On the 48th hour after enrollment (On the 24th hour after crossover)
FiO2	Fraction of inspiration O2	On the third day after enrollment (On the 48th hour after crossover)
FiO2	Fraction of inspiration O2	On the 4th day after enrollment (On the third day after crossover)
FiO2	Fraction of inspiration O2	On the 5th day after enrollment (On the 4th day after crossover)
FiO2	Fraction of inspiration O2	On the 6th day after enrollment (On the 5th day after crossover)
FiO2	Fraction of inspiration O2	On the 7th day after enrollment (On the 6th day after crossover)
FiO2	Fraction of inspiration O2	On the 8th day after enrollment (On the 7th day after crossover)
FiO2	Fraction of inspiration O2	On the 9th day after enrollment (On the 8th day after crossover)
Lac	Lactic acid in arterial blood	At the time of enrollment in the clinical study
Lac	Lactic acid in arterial blood	On the 24th hour after enrollment
Lac	Lactic acid in arterial blood	On the 48th hour after enrollment (On the 24th hour after crossover)
Lac	Lactic acid in arterial blood	On the third day after enrollment (On the 48th hour after crossover)
Lac	Lactic acid in arterial blood	On the 4th day after enrollment (On the third day after crossover)
Lac	Lactic acid in arterial blood	On the 5th day after enrollment (On the 4th day after crossover)
Lac	Lactic acid in arterial blood	On the 6th day after enrollment (On the 5th day after crossover)
Lac	Lactic acid in arterial blood	On the 7th day after enrollment (On the 6th day after crossover)
Lac	Lactic acid in arterial blood	On the 8th day after enrollment (On the 7th day after crossover)
Lac	Lactic acid in arterial blood	On the 9th day after enrollment (On the 8th day after crossover)
Glu	Arterial blood glucose in arterial blood	At the time of enrollment in the clinical study
Glu	Arterial blood glucose in arterial blood	On the 24th hour after enrollment
Glu	Arterial blood glucose in arterial blood	On the 48th hour after enrollment (On the 24th hour after crossover)
Glu	Arterial blood glucose in arterial blood	On the third day after enrollment (On the 48th hour after crossover)
GLu	Arterial blood glucose in arterial blood	On the 4th day after enrollment (On the third day after crossover)
Glu	Arterial blood glucose in arterial blood	On the 5th day after enrollment (On the 4th day after crossover)
Glu	Arterial blood glucose in arterial blood	On the 6th day after enrollment (On the 5th day after crossover)
Glu	Arterial blood glucose in arterial blood	On the 7th day after enrollment (On the 6th day after crossover)
Glu	Arterial blood glucose in arterial blood	On the 8th day after enrollment (On the 7th day after crossover)
Glu	Arterial blood glucose in arterial blood	On the 9th day after enrollment (On the 8th day after crossover)
A-aDO2	The difference between the oxygen partial pressure of alveolar air and the oxygen partial pressure of arterial blood	At the time of enrollment in the clinical study
A-aDO2	The difference between the oxygen partial pressure of alveolar air and the oxygen partial pressure of arterial blood	On the 24th hour after enrollment
A-aDO2	The difference between the oxygen partial pressure of alveolar air and the oxygen partial pressure of arterial blood	On the 48th hour after enrollment (On the 24th hour after crossover)
A-aDO2	The difference between the oxygen partial pressure of alveolar air and the oxygen partial pressure of arterial blood	On the third day after enrollment (On the 48th hour after crossover)
A-aDO2	The difference between the oxygen partial pressure of alveolar air and the oxygen partial pressure of arterial blood	On the 4th day after enrollment (On the third day after crossover)
A-aDO2	The difference between the oxygen partial pressure of alveolar air and the oxygen partial pressure of arterial blood	On the 5th day after enrollment (On the 4th day after crossover)
A-aDO2	The difference between the oxygen partial pressure of alveolar air and the oxygen partial pressure of arterial blood	On the 6th day after enrollment (On the 5th day after crossover)
A-aDO2	The difference between the oxygen partial pressure of alveolar air and the oxygen partial pressure of arterial blood	On the 7th day after enrollment (On the 6th day after crossover)
A-aDO2	The difference between the oxygen partial pressure of alveolar air and the oxygen partial pressure of arterial blood	On the 8th day after enrollment (On the 7th day after crossover)
A-aDO2	The difference between the oxygen partial pressure of alveolar air and the oxygen partial pressure of arterial blood	On the 9th day after enrollment (On the 8th day after crossover)
BE	Base excess in arterial blood	At the time of enrollment in the clinical study
BE	Base excess in arterial blood	On the 24th hour after enrollment
BE	Base excess in arterial blood	On the 48th hour after enrollment (On the 24th hour after crossover)
BE	Base excess in arterial blood	On the third day after enrollment (On the 48th hour after crossover)
BE	Base excess in arterial blood	On the 4th day after enrollment (On the third day after crossover)
BE	Base excess in arterial blood	On the 5th day after enrollment (On the 4th day after crossover)
BE	Base excess in arterial blood	On the 6th day after enrollment (On the 5th day after crossover)
BE	Base excess in arterial blood	On the 7th day after enrollment (On the 6th day after crossover)
BE	Base excess in arterial blood	On the 8th day after enrollment (On the 7th day after crossover)
BE	Base excess in arterial blood	On the 9th day after enrollment (On the 8th day after crossover)
RI	Respiratory Index	At the time of enrollment in the clinical study
RI	Respiratory Index	On the 24th hour after enrollment
RI	Respiratory Index	On the 48th hour after enrollment (On the 24th hour after crossover)
RI	Respiratory Index	On the third day after enrollment (On the 48th hour after crossover)
RI	Respiratory Index	On the 4th day after enrollment (On the third day after crossover)
RI	Respiratory Index	On the 5th day after enrollment (On the 4th day after crossover)
RI	Respiratory Index	On the 6th day after enrollment (On the 5th day after crossover)
RI	Respiratory Index	On the 7th day after enrollment (On the 6th day after crossover)
RI	Respiratory Index	On the 8th day after enrollment (On the 7th day after crossover)
RI	Respiratory Index	On the 9th day after enrollment (On the 8th day after crossover)
Arterial blood HCO3- concentration	Arterial blood HCO3- concentration，including arterial blood HCO3- std concentration	At the time of enrollment in the clinical study
Arterial blood HCO3- concentration	Arterial blood HCO3- concentration，including arterial blood HCO3- std concentration	On the 24th hour after enrollment
Arterial blood HCO3- concentration	Arterial blood HCO3- concentration，including arterial blood HCO3- std concentration	On the 48th hour after enrollment (On the 24th hour after crossover)
Arterial blood HCO3- concentration	Arterial blood HCO3- concentration，including arterial blood HCO3- std concentration	On the third day after enrollment (On the 48th hour after crossover)
Arterial blood HCO3- concentration	Arterial blood HCO3- concentration，including arterial blood HCO3- std concentration	On the 4th day after enrollment (On the third day after crossover)
Arterial blood HCO3- concentration	Arterial blood HCO3- concentration，including arterial blood HCO3- std concentration	On the 5th day after enrollment (On the 4th day after crossover)
Arterial blood HCO3- concentration	Arterial blood HCO3- concentration，including arterial blood HCO3- std concentration	On the 6th day after enrollment (On the 5th day after crossover)
Arterial blood HCO3- concentration	Arterial blood HCO3- concentration，including arterial blood HCO3- std concentration	On the 7th day after enrollment (On the 6th day after crossover)
Arterial blood HCO3- concentration	Arterial blood HCO3- concentration，including arterial blood HCO3- std concentration	On the 8th day after enrollment (On the 7th day after crossover)
Arterial blood HCO3- concentration	Arterial blood HCO3- concentration，including arterial blood HCO3- std concentration	On the 9th day after enrollment (On the 8th day after crossover)
Arterial blood K+ concentration	Arterial blood K+ concentration	At the time of enrollment in the clinical study
Arterial blood K+ concentration	Arterial blood K+ concentration	On the 24th hour after enrollment
Arterial blood K+ concentration	Arterial blood K+ concentration	On the 48th hour after enrollment (On the 24th hour after crossover)
Arterial blood K+ concentration	Arterial blood K+ concentration	On the third day after enrollment (On the 48th hour after crossover)
Arterial blood K+ concentration	Arterial blood K+ concentration	On the 4th day after enrollment (On the third day after crossover)
Arterial blood K+ concentration	Arterial blood K+ concentration	On the 5th day after enrollment (On the 4th day after crossover)
Arterial blood K+ concentration	Arterial blood K+ concentration	On the 6th day after enrollment (On the 5th day after crossover)
Arterial blood K+ concentration	Arterial blood K+ concentration	On the 7th day after enrollment (On the 6th day after crossover)
Arterial blood K+ concentration	Arterial blood K+ concentration	On the 8th day after enrollment (On the 7th day after crossover)
Arterial blood K+ concentration	Arterial blood K+ concentration	On the 9th day after enrollment (On the 8th day after crossover)
Arterial blood Ca2+ concentration	Arterial blood Ca2+ concentration	At the time of enrollment in the clinical study
Arterial blood Ca2+ concentration	Arterial blood Ca2+ concentration	On the 24th hour after enrollment
Arterial blood Ca2+ concentration	Arterial blood Ca2+ concentration	On the 48th hour after enrollment (On the 24th hour after crossover)
Arterial blood Ca2+ concentration	Arterial blood Ca2+ concentration	On the third day after enrollment (On the 48th hour after crossover)
Arterial blood Ca2+ concentration	Arterial blood Ca2+ concentration	On the 4th day after enrollment (On the third day after crossover)
Arterial blood Ca2+ concentration	Arterial blood Ca2+ concentration	On the 5th day after enrollment (On the 4th day after crossover)
Arterial blood Ca2+ concentration	Arterial blood Ca2+ concentration	On the 6th day after enrollment (On the 5th day after crossover)
Arterial blood Ca2+ concentration	Arterial blood Ca2+ concentration	On the 7th day after enrollment (On the 6th day after crossover)
Arterial blood Ca2+ concentration	Arterial blood Ca2+ concentration	On the 8th day after enrollment (On the 7th day after crossover)
Arterial blood Ca2+ concentration	Arterial blood Ca2+ concentration	On the 9th day after enrollment (On the 8th day after crossover)
Arterial blood Na+ concentration	Arterial blood Na+ concentration	At the time of enrollment in the clinical study
Arterial blood Na+ concentration	Arterial blood Na+ concentration	On the 24th hour after enrollment
Arterial blood Na+ concentration	Arterial blood Na+ concentration	On the 48th hour after enrollment (On the 24th hour after crossover)
Arterial blood Na+ concentration	Arterial blood Na+ concentration	On the third day after enrollment (On the 48th hour after crossover)
Arterial blood Na+ concentration	Arterial blood Na+ concentration	On the 4th day after enrollment (On the third day after crossover)
Arterial blood Na+ concentration	Arterial blood Na+ concentration	On the 5th day after enrollment (On the 4th day after crossover)
Arterial blood Na+ concentration	Arterial blood Na+ concentration	On the 6th day after enrollment (On the 5th day after crossover)
Arterial blood Na+ concentration	Arterial blood Na+ concentration	On the 7th day after enrollment (On the 6th day after crossover)
Arterial blood Na+ concentration	Arterial blood Na+ concentration	On the 8th day after enrollment (On the 7th day after crossover)
Arterial blood Na+ concentration	Arterial blood Na+ concentration	On the 9th day after enrollment (On the 8th day after crossover)
TCO2	Total carbon dioxide in arterial blood	At the time of enrollment in the clinical study
TCO2	Total carbon dioxide in arterial blood	On the 24th hour after enrollment
TCO2	Total carbon dioxide in arterial blood	On the 48th hour after enrollment (On the 24th hour after crossover)
TCO2	Total carbon dioxide in arterial blood	On the third day after enrollment (On the 48th hour after crossover)
TCO2	Total carbon dioxide in arterial blood	On the 4th day after enrollment (On the third day after crossover)
TCO2	Total carbon dioxide in arterial blood	On the 5th day after enrollment (On the 4th day after crossover)
TCO2	Total carbon dioxide in arterial blood	On the 6th day after enrollment (On the 5th day after crossover)
TCO2	Total carbon dioxide in arterial blood	On the 7th day after enrollment (On the 6th day after crossover)
TCO2	Total carbon dioxide in arterial blood	On the 8th day after enrollment (On the 7th day after crossover)
TCO2	Total carbon dioxide in arterial blood	On the 9th day after enrollment (On the 8th day after crossover)
HCT	hematocrit in arterial blood	At the time of enrollment in the clinical study
HCT	hematocrit in arterial blood	On the 24th hour after enrollment
HCT	hematocrit in arterial blood	On the 48th hour after enrollment (On the 24th hour after crossover)
HCT	hematocrit in arterial blood	On the third day after enrollment (On the 48th hour after crossover)
HCT	hematocrit in arterial blood	On the 4th day after enrollment (On the third day after crossover)
HCT	hematocrit in arterial blood	On the 5th day after enrollment (On the 4th day after crossover)
HCT	hematocrit in arterial blood	On the 6th day after enrollment (On the 5th day after crossover)
HCT	hematocrit in arterial blood	On the 7th day after enrollment (On the 6th day after crossover)
HCT	hematocrit in arterial blood	On the 8th day after enrollment (On the 7th day after crossover)
HCT	hematocrit in arterial blood	On the 9th day after enrollment (On the 8th day after crossover)
tHbc	Total hemoglobin in arterial blood	At the time of enrollment in the clinical study
tHbc	Total hemoglobin in arterial blood	On the 24th hour after enrollment
tHbc	Total hemoglobin in arterial blood	On the 48th hour after enrollment (On the 24th hour after crossover)
tHbc	Total hemoglobin in arterial blood	On the third day after enrollment (On the 48th hour after crossover)
tHbc	Total hemoglobin in arterial blood	On the 4th day after enrollment (On the third day after crossover)
tHbc	Total hemoglobin in arterial blood	On the 5th day after enrollment (On the 4th day after crossover)
tHbc	Total hemoglobin in arterial blood	On the 6th day after enrollment (On the 5th day after crossover)
tHbc	Total hemoglobin in arterial blood	On the 7th day after enrollment (On the 6th day after crossover)
tHbc	Total hemoglobin in arterial blood	On the 8th day after enrollment (On the 7th day after crossover)
tHbc	Total hemoglobin in arterial blood	On the 9th day after enrollment (On the 8th day after crossover)
height	m	At the time of enrollment in the clinical study
Weight	Kg	At the time of enrollment in the clinical study
gender	Male and female	At the time of enrollment in the clinical study
age	year	At the time of enrollment in the clinical study
WBC	The number of white blood cells in venous blood	On the first day after enrollment
WBC	The number of white blood cells in venous blood	up to 9 days
NEU	The number of Neutrophil granulocyte in venous blood	On the first day after enrollment
NEU	The number of Neutrophil granulocyte in venous blood	up to 9 days
LYM	The number of Venous blood lymphocytes in venous blood	On the first day after enrollment
LYM	The number of Venous blood lymphocytes in venous blood	up to 9 days
EOS	The number of Venous blood eosinophils in venous blood	On the first day after enrollment
EOS	The number of Venous blood eosinophils in venous blood	up to 9 days
BAS	The number of Venous blood Basophils in venous blood	On the first day after enrollment
BAS	The number of Venous blood Basophils in venous blood	up to 9 days
MON	The number of Venous blood Monocyte cell in venous blood	On the first day after enrollment
MON	The number of Venous blood Monocyte cell in venous blood	up to 9 days
RBC	The number of red blood cells in venous blood	On the first day after enrollment
RBC	The number of red blood cells in venous blood	up to 9 days
HGB	The number of haemoglobin in venous blood	On the first day after enrollment
HGB	The number of haemoglobin in venous blood	up to 9 days
HCT	hematocrit in venous blood	On the first day after enrollment
HCT	hematocrit in venous blood	up to 9 days
MCV	Mean Corpuscular Volume in venous blood	On the first day after enrollment
MCV	Mean Corpuscular Volume in venous blood	up to 9 days
MCH	Mean Corpuscular Haemoglobin Concentration in venous blood	On the first day after enrollment
MCH	Mean Corpuscular Haemoglobin Concentration in venous blood	up to 9 days
RDW	red blood cell distribution width in venous blood	On the first day after enrollment
RDW	red blood cell distribution width in venous blood	up to 9 days
PLT	platelet in venous blood	On the first day after enrollment
PLT	platelet in venous blood	up to 9 days
PDW	Platelet distributionwidth in venous blood	On the first day after enrollment
PDW	Platelet distributionwidth in venous blood	up to 9 days
MPV	Mean Platelet Volume in venous blood	On the first day after enrollment
MPV	Mean Platelet Volume in venous blood	up to 9 days
plateletcrit	plateletcrit in venous blood	On the first day after enrollment
plateletcrit	plateletcrit in venous blood	up to 9 days
CRP	C-reactive protein in venous blood	On the first day after enrollment
CRP	C-reactive protein in venous blood	up to 9 days
PCT	Procalcitonin in venous blood	On the first day after enrollment
PCT	Procalcitonin in venous blood	up to 9 days
NT-proBNP	NT-proBNP in venous blood	On the first day after enrollment
NT-proBNP	NT-proBNP in venous blood	up to 9 days
ESR	erythrocytesedimentationrate in venous blood	On the first day after enrollment
ESR	erythrocytesedimentationrate in venous blood	up to 9 days
PT	prothrombin time in venous blood	On the first day after enrollment
PT	prothrombin time in venous blood	up to 9 days
APTT	activated partial thromboplastin time in venous blood	On the first day after enrollment
APTT	activated partial thromboplastin time in venous blood	up to 9 days
TT	Thrombin time in venous blood	On the first day after enrollment
TT	Thrombin time in venous blood	up to 9 days
D-Di	D-Dimer in venous blood	On the first day after enrollment
D-Di	D-Dimer in venous blood	up to 9 days
ALT	alanine transaminase in venous blood	On the first day after enrollment
ALT	alanine transaminase in venous blood	up to 9 days
AST	Aspartate Transaminase in venous blood	On the first day after enrollment
AST	Aspartate Transaminase in venous blood	up to 9 days
PA	Serum prealbumin in venous blood	On the first day after enrollment
PA	Serum prealbumin in venous blood	up to 9 days
TP	Total serum protein in venous blood	On the first day after enrollment
TP	Total serum protein in venous blood	up to 9 days
ALB	Albumin protein in venous blood	On the first day after enrollment
ALB	Albumin protein in venous blood	up to 9 days
GLB	Globulin globulin in venous blood	On the first day after enrollment
GLB	Globulin globulin in venous blood	up to 9 days
Cr	creatinine in venous blood	On the first day after enrollment
Cr	creatinine in venous blood	up to 9 days
BUN	Urea nitrogen in venous blood	On the first day after enrollment
BUN	Urea nitrogen in venous blood	up to 9 days
Cys-C	Cystatin C in venous blood	On the first day after enrollment
Cys-C	Cystatin C in venous blood	up to 9 days
eGFR	Estimate glomerular filtration rate in venous blood	On the first day after enrollment
eGFR	Estimate glomerular filtration rate in venous blood	up to 9 days
Respiratory support time	Daily respiratory support time after patients were enrolled in the clinical study，h/Day	during hospitalization, approximately 9 days
Relief time for dyspnea	Remission time of dyspnea after intervention	during hospitalization, approximately 9 days
Tracheal intubation	Yes or No	during hospitalization, approximately 9 days
Stay in the ICU	Yes or No	during hospitalization, approximately 9 days
Complications	Facial injury, flatulence，Gastroesophageal reflux，Dry throat, sore throat，pneumothorax，Eye irritation discomfort，Low blood pressure.	during hospitalization, approximately 9 days
Outcome of disease	Get better, get worse, die	during hospitalization, approximately 9 days
Total bilirubin	Serum total bilirubin in venous blood	On the first day after enrollment
Total bilirubin	Serum total bilirubin in venous blood	up to 9 days
DBIL	Direct bilirubin in venous blood	On the first day after enrollment
DBIL	Direct bilirubin in venous blood	up to 9 days
IBIL	Indirect bilirubin in venous blood	On the first day after enrollment
IBIL	Indirect bilirubin in venous blood	up to 9 days
Diaphragm mobility	The patient is lying in a flat position. The convex array probe is placed at the junction of the anterior axillary line, midclavicular line, and rib margin (bilaterally), with the probe mark facing outward and downward for measurement.	At the time of enrollment in the clinical study
Diaphragm mobility	The patient is lying in a flat position. The convex array probe is placed at the junction of the anterior axillary line, midclavicular line, and rib margin (bilaterally), with the probe mark facing outward and downward for measurement.	On the 24th hour after enrollment
Diaphragm mobility	The patient is lying in a flat position. The convex array probe is placed at the junction of the anterior axillary line, midclavicular line, and rib margin (bilaterally), with the probe mark facing outward and downward for measurement.	On the 48th hour after enrollment (On the 24th hour after crossover)
Diaphragm mobility	The patient is lying in a flat position. The convex array probe is placed at the junction of the anterior axillary line, midclavicular line, and rib margin (bilaterally), with the probe mark facing outward and downward for measurement.	up to 9 days
Diaphragm thickness	Includes end-inspiratory diaphragm thickness and end-expiratory diaphragm thickness；The patient is lying flat on the bed. A linear array probe is placed in the mid-axillary line or between the anterior and mid-axillary lines between the eighth and tenth ribs, and measurements are taken.	At the time of enrollment in the clinical study
Diaphragm thickness	Includes end-inspiratory diaphragm thickness and end-expiratory diaphragm thickness；The patient is lying flat on the bed. A linear array probe is placed in the mid-axillary line or between the anterior and mid-axillary lines between the eighth and tenth ribs, and measurements are taken.	On the 24th hour after enrollment
Diaphragm thickness	Includes end-inspiratory diaphragm thickness and end-expiratory diaphragm thickness；The patient is lying flat on the bed. A linear array probe is placed in the mid-axillary line or between the anterior and mid-axillary lines between the eighth and tenth ribs, and measurements are taken.	On the 48th hour after enrollment (On the 24th hour after crossover)
Diaphragm thickness	Includes end-inspiratory diaphragm thickness and end-expiratory diaphragm thickness；The patient is lying flat on the bed. A linear array probe is placed in the mid-axillary line or between the anterior and mid-axillary lines between the eighth and tenth ribs, and measurements are taken.	up to 9 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient compliance to the treatment	Patients were managed for compliance with the treatment.Dependent judgment; Complete dependence: patients actively cooperate with medical staff in treatment; Partial dependence: in most cases, patients can cooperate with the treatment, and in a few cases, patients resist the treatment but receive treatment after being enlightened by the medical staff.; Non-dependence: patients have strong resistance and resistance, so that they are unable to use ventilators or nasal high-flow humidification instruments.	during hospitalization, approximately 9 days
Kolcaba Comfort Scale (GCQ) assessment assesses patient comfort	Kolcaba's General Comfort Questionnaire (GCQ) is composed of 28 items from 4 dimensions: physiological, psychological, spiritual, socio-cultural and environmental. The modification Scale adopts 1 to 4Likert Scale, with 1 indicating strongly disagree and 4 indicating strongly agree. In the negative question, 1 means strongly agree and 4 means strongly disagree. A higher score indicates more comfort.	during hospitalization, approximately 9 days
Dyspnea rating scale	According to the degree of dyspnea and symptoms of the patient, the lowest score is 0, the highest score is 10.	during hospitalization, approximately 9 days

Collaborators and Investigators

• Sponsor: Qilu Hospital of Shandong University
• Investigators: Principal Investigator: Dedong Ma, MD, Qilu Hospital of Shandong University

Publications and helpful links

General Publications

• Milesi C, Essouri S, Pouyau R, Liet JM, Afanetti M, Portefaix A, Baleine J, Durand S, Combes C, Douillard A, Cambonie G; Groupe Francophone de Reanimation et d'Urgences Pediatriques (GFRUP). High flow nasal cannula (HFNC) versus nasal continuous positive airway pressure (nCPAP) for the initial respiratory management of acute viral bronchiolitis in young infants: a multicenter randomized controlled trial (TRAMONTANE study). Intensive Care Med. 2017 Feb;43(2):209-216. doi: 10.1007/s00134-016-4617-8. Epub 2017 Jan 26.
• Lewis SR, Baker PE, Parker R, Smith AF. High-flow nasal cannulae for respiratory support in adult intensive care patients. Cochrane Database Syst Rev. 2021 Mar 4;3(3):CD010172. doi: 10.1002/14651858.CD010172.pub3.
• Chen BX, Ou Q, Pan MX. [A cross-sectional survey of treatment acceptance and influence factors in patients with obstructive sleep apnea]. Zhonghua Yi Xue Za Zhi. 2018 May 29;98(20):1578-1581. doi: 10.3760/cma.j.issn.0376-2491.2018.20.010. Chinese.

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2023
• Primary Completion (Anticipated): June 1, 2024
• Study Completion (Anticipated): June 6, 2024

Study Registration Dates

• First Submitted: September 19, 2022
• First Submitted That Met QC Criteria: March 13, 2023
• First Posted (Actual): March 27, 2023

Study Record Updates

• Last Update Posted (Actual): March 27, 2023
• Last Update Submitted That Met QC Criteria: March 13, 2023
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Hypoxemia, High-flow nasal cannula, Mechanical ventilation
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia
• Other Study ID Numbers: 2022039

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No