High Flow Nasal Oxygen Therapy in Perioperative Period of the Adult With Hypercapnic and Hypoxemic Respiratory Faliure

The purpose of this study is to determine the impact of hign-flow nasal therapy on the adult with hypercapnia and hpoxemia respiratory faliure in comparison with standard oxygen therapy ang noninvasive ventilation.

Study Overview

• Status: Unknown
• Conditions: Acute Respiratory Failure With Hypercapnia
• Intervention / Treatment: Other: standard low flow therapy; Device: high flow nasal oxygen therapy; Device: association of high flow nasal oxygen therapy and non invasive positive pressure ventilation

Detailed Description

Humidified high flow nasal oxygen therapy decreases dilution of the inhaled oxygen and, by matching patient's peak flow, allows accurate delivery of the set FiO2 throughout the whole inspiratory phase.The purpose of this study is to determine the impact of hign-flow nasal therapy on adult hypercapnic respiratory failure by comparing with nasal continuous positive airway pressure

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200092
      • Recruiting
      • Ethics Committee of Xinhua Hospital
      • Contact: Guangyu Chen, PhD; Phone Number: +86-02125076143; Email: xinhuacru@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Hypoxemic and no hypercapnic acute respiratory failure :
• severe dyspnea at rest with a respiratory rate >25 breaths/min
• PaO2/FiO2 <300
• PaCO2 <45 mmHg,

Exclusion Criteria:

• age <18 years
• NPPV contraindications
• past history of respiratory chronic disease (COPD, cystic fibrosis…)
• cardiac pulmonary edema
• Pre-defined intubation
• other than respiratory organ failure : systolic pressure <90 mmHg,current treatment with epinephrine or norepinephrine, decreased level of consciousness ( Glasgow score ≤ 12)
• profound aplasia (white cells count <1000/mm 3)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: standard low flow therapy; In the standard low flow therapy is applied continuously through a nonrebreather face mask at a flow rate of 10 liters per minute or more. The rate was adjusted to maintain an oxygen saturation level of 92% or more.	Other: standard low flow therapy; In the standard low flow therapy oxygen group, oxygen at a flow rate of 10 liters per minute or more.
Experimental: high flow nasal oxygen therapy; In the high-flow-oxygen group is passed through a heated humidifier and applied continuously through large-bore binasal prongs, with a gas flow rate of 30-60 liters per minute . The fraction of oxygen in the gas flowing in the system was subsequently adjusted to maintain an Spo2 of 92% or more.	Device: high flow nasal oxygen therapy; The patient will receive high flow nasal of humidified oxygen, set between 30 to 60 l/min. The inspired fraction of oxygen (FiO2) will be adjusted in order to obtain a SpO2 >92%.
Placebo Comparator: Noninvasive ventilation; In the noninvasive-ventilation group is delivered to the patient through a face mask that was connected to an ICU ventilator,with pressure support applied in a noninvasive ventilation mode. The Fio2 or PEEP level (or both) were then adjusted to maintain an Spo2 of 92% or more.	Device: association of high flow nasal oxygen therapy and non invasive positive pressure ventilation; The patient will receive successively in a day NPPV and O2-HFN. The NPPV will be applied with an airway humidification achieved by using a heated humidifier and a facial mask adapted to the morphology of the patient. The settings will be adjusted as follow : an inspiratory pressure between 6 to 14 cmH2O, in order to obtain a tidal volume between 7 to 10 ml/kg of predicted weight, a positive expiratory pressure between 0 to 10 cmH2O in order to obtain a SpO2 >92% with the minimal FiO2.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the number of patients in each group who require endotracheal intubation with mechanical ventilation	To compare the number of patients in each group who require endotracheal intubation with mechanical ventilation	28days

Secondary Outcome Measures

Outcome Measure	Time Frame
mechanical ventilation-free to day 28	28 days

Collaborators and Investigators

• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2019
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: July 23, 2017
• First Submitted That Met QC Criteria: July 23, 2017
• First Posted (Actual): July 25, 2017

Study Record Updates

• Last Update Posted (Actual): December 5, 2018
• Last Update Submitted That Met QC Criteria: December 3, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Respiratory Insufficiency; Hypercapnia
• Other Study ID Numbers: XH-17-008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes