Diaphragmatic Ultrasound to Predict the Therapeutic Effect of High-flow Nasal Cannula Oxygen Therapy

Clinical Study of Diaphragmatic Ultrasound to Predict the Therapeutic Effect of High Flow Oxygen Therapy in Mild and Moderate Acute Hypoxic Respiratory Failure

Follow-up was conducted for every patient requiring high-flow nasal cannula oxygen therapy in district 1 of the Intensive Care Department of Chenzhou NO.1 People's Hospital. Patients who met the inclusion criteria but did not meet the exclusion criteria were included for observation. Respiratory parameters, diaphragmatic activity, and variation rate of diaphragmatic thickness were recorded at the beginning of high-flow nasal cannula oxygen therapy, 1 hour after treatment, 3 hours after treatment, 6 hours after treatment, 9 hours after treatment, and 12 hours after treatment. Throughout the procedure, a panel of experts assessed whether the patient needed endotracheal intubation; If yes, the study was terminated; if no, high-flow nasal cannula oxygen therapy was continued, and observation and evaluation were continued until the end point of the study (12 hours after treatment). If patients or their family members do not want to continue to participate in the study during the study, they will be considered as withdrawal. If patients suffer from sudden malignant arrhythmia or cardiac arrest during the study, resulting in death or transfer to other hospitals or other departments during the study, patients will be excluded. Data from dropped and excluded patients were not included in the final statistical analysis. After the data of 269 patients were collected, the study was concluded, and the results and conclusions were derived by statistical analysis.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypoxic Respiratory Failure
• Intervention / Treatment: Diagnostic test: Diaphragm ultrasound

• Study Type: Observational
• Enrollment (Estimated): 269

Contacts and Locations

• Study Contact: Name: Feng Yang, Master; Phone Number: 15886524007; Email: 17546639@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with mild to moderate hypoxic respiratory failure who are over 18 years old and less than 75 years old and who do not have serious cardiopulmonary disease, malnutrition, or respiratory obstruction and require high-flow nasal cannula oxygen therapy

Description

Inclusion Criteria:

1. Age ≥18 years old, less than 75 years old,BMI≥18.5kg/m2
2. Mild to moderate type I respiratory failure (100mmHg< PaO2/FiO2≤300mmHg)
3. Mild ventilation dysfunction (pH≥7.3)
4. Mild respiratory distress (respiratory rate > 24 times/min)
5. High-flow nasal cannula oxygen therapy is required
6. The patient and immediate family members agree and sign a written informed consent.

Exclusion Criteria:

1. Patients with severe type II respiratory failure, severe asthma and massive hemoptysis
2. Moderate to severe consciousness disorder, GCS score ≤12 points
3. Cardiogenic pulmonary edema and cardiogenic dyspnea caused by heart failure, heart valvular disease, myocarditis, etc
4. Hemodynamic instability, SBP< 90mmHg, or MAP<65mmHg
5. BMI < 18.5kg/m2
6. Nasal bleeding, nasal space occupying lesions, etc., can not be high-flow nasal cannula oxygen therapy through the nose or nasal obstruction
7. Patients with severe hypoxemia, severe ARDS and other conditions requiring immediate tracheal intubation
8. The patient or family member refuses to participate or does not agree to sign the written informed consent
9. The patient has participated in other research projects with interventions

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thickness and thickening fraction of Diaphragm	Diaphragm thickness and thickening fraction (TFdi) were measured using a high-frequency linear array probe at the midaxillary line. TFdi = (diaphragm thickness at the end of inspirations - diaphragm thickness at the end of expirations)/diaphragm thickness at the end of expirations × 100%	0-12 hours
Diaphragmatic excursion	Diaphragmatic excursion was measured using a low-frequency curved array (" abdomen ") probe located directly below the costal arch on the midline of the clavicle.	0-12 hours
Respiratory rate	Respiratory rate of the patient after high-flow nasal oxygen therapy	0-12 hours
Incidence of tracheal intubation	After the patient uses high-flow nasal oxygen therapy, the panel determine whether the patient needs to undergo tracheal intubation according to the indicators such as symptoms and signs of the patient.	0-12 hours

Collaborators and Investigators

• Sponsor: Xingui Dai

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: March 13, 2024
• First Submitted That Met QC Criteria: March 26, 2024
• First Posted (Actual): March 28, 2024

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Respiratory Insufficiency; Hypoxia
• Other Study ID Numbers: Diaphragm ultrasound

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