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

Respiratory Failure Clinical Trial

— HONIVAH  

Official title:

Effects of High-flow Oxygen Therapy and Non-invasive Ventilation on Lung Volumes and on Upper Airway in Hypoxemic Critical Care Patients: a Physiological Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05643911
• Other study ID #: RECHMPL22_0510
• Status: Recruiting
• Phase: N/A
• Start date: January 27, 2023
• Est. completion date: January 2025

Study information

• Verified date: May 2024
• Source: University Hospital, Montpellier
• Contact: Samir JABER
• Phone: 0033467337271
• Email: s-jaber[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Failure
• Respiratory Insufficiency

Intervention

Procedure:
• HFNC
In the HFNC group, patients will receive HFNC oxygen therapy for 20 minutes.
• NIV
Patients will receive NIV for 20 minutes delivered with a naso-buccal or face mask according to the patient's tolerance.

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire Montpellier, Saint Eloi	Montpellier	Languedoc-Roussillon

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

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