Effects of High-flow Oxygen Therapy and Non-invasive Ventilation on Lung Volumes and on Upper Airway

Not Applicable

Recruiting

• Conditions: Respiratory Failure
• Interventions: Procedure: NIV; Procedure: HFNC

• Registration Number: NCT05643911
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

Respiratory failure is the most frequent organ failure and cause for admission in the Intensive Care Unit (ICU) . It is a severe complication with an ICU mortality ranged from 31% to 33%. Symptomatic treatment of hypoxemic respiratory failure is a controversial topic with different options: 1) standard oxygen therapy, 2) high flow nasal cannula oxygen therapy (HFNC) and 3) non-invasive ventilation (NIV).

The aim of the study is to compare HFNC versus NIV ventilation using CT scan. The hypothesis of this study is that in hypoxemic critically ill patients, the increase of lung volumes with NIV would be significantly higher than the increase of lung volumes with HFNC.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-17
• Study First Submitted QC: 2022-12-01
• Study First Posted: 2022-12-09
• Study Start: 2023-01-27
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-27
• Last Update Posted: 2024-05-29
• Primary Completion: 2025-01
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• Patient with hypoxemia at any time of ICU stay defined as follow: standard oxygen therapy flow ≥ 3L/min to maintain a pulsed oxygen saturation ≥ 95%
• Adult (age ≥ 18 years)
• (2) A CT scan prescribed by the physician in charge of the patient as part of the exploration of the patient's pathology and not as part of a "dedicated" prescription for the study.

Exclusion Criteria

• NIV contraindication (need for immediate endotracheal intubation and mechanical ventilation; hemodynamic instability defined by systolic blood pressure < 90 mmHg or mean blood pressure < 65 mmHg, use of vasopressors; Glasgow Coma Scale score of 12 points or less)
• History of recent facial trauma not compatible with the use of nasal cannulas
• Pregnancy
• Refusal of study participation
• protected person
• Patient not affiliated to the social security system or not benefiting from such a system
• Lack of signed informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-invasive ventilation (NIV)	NIV	In the NIV Group, patients will receive NIV for 20 minutes delivered with a naso-buccal or face mask according to the patient's tolerance. The pressure-support level will be adjusted with the aim of an expired tidal volume of 6 to 8 ml per kilogram of predicted body weight, with a positive end-expiratory pressure (PEEP) of 5 cmH2O. The FiO2 will be adjusted to maintain a SpO2 between 95% and 98%.
HFNC (Hight-flow oxygen therapy)	HFNC	In the HFNC group, patients will receive HFNC oxygen therapy for 20 minutes. Oxygen will be passed through a heated humidifier and continuously delivered through medium or large nasal cannulas (OptiflowTM, Fisher and Paykel Healthcare) depending on patient anatomy, with a gas flow of 50 litres per minute and the FiO2 will be adjusted to maintain a SpO2 between 95% and 98%.

Primary Outcome Measures

Name	Time	Method
Variation in poorly aerated lung volume	the day of inclusion	The poorly aerated volume will be measured by CT scan
Variation in non-aereted lung volume	the day of inclusion	The non-aereted volume will be measured by CT scan

Secondary Outcome Measures

Name	Time	Method
Variation in cross-sectional upper airway area	the day of inclusion	The variation will be measured by CT-scan in mm
Variation in Positive End Expiratory Pressure (PEEP)	the day of inclusion
Variation in Total lung volume	the day of inclusion	The total lung volume will be measured by CT-scan
Variation in normally aerated lung volume	the day of inclusion	The normally aerated lung volume will be measured by CT scan
Variation in respiratory rate	the day of inclusion	Respiratory rate is the number of cycles per minute
Variation in cardiac output (Qc)	the day of inclusion	the cardiac output is in L/min
Variation in O2 gas exchange	the day of inclusion	Change in PaO2 in mmHg
Variation in CO2 gas exchange	the day of inclusion	Change in PaO2 in mmHg
Variation in patient comfort	the day of inclusion	Patient comfort through a numeric rating scale (NRS) from 0 (no discomfort) to 10 (maximum imaginable discomfort)

Trial Locations

Locations (1)

Centre Hospitalier Universitaire Montpellier, Saint Eloi; 🇫🇷 Montpellier, Languedoc-Roussillon, France