Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HFNC (Hight-flow oxygen therapy) | Experimental | 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%. |
|
| Non-invasive ventilation (NIV) | Active Comparator | 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%. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HFNC | Procedure | In the HFNC group, patients will receive HFNC oxygen therapy for 20 minutes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Variation in poorly aerated lung volume | The poorly aerated volume will be measured by CT scan | the day of inclusion |
| Variation in non-aereted lung volume | The non-aereted volume will be measured by CT scan | the day of inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Variation in cross-sectional upper airway area | The variation will be measured by CT-scan in mm | the day of inclusion |
| Variation in normally aerated lung volume | The normally aerated lung volume will be measured by CT scan |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Samir JABER | Contact | 0033467337271 | s-jaber@chu-montpellier.fr |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire Montpellier, Saint Eloi | Recruiting | Montpellier | Languedoc-Roussillon | 34295 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40962342 | Derived | Monet C, Piron L, Pressac M, Molinari N, De Jong A, Guiu B, Jaber S. Study protocol for the HONIVAH trial: a single-centre randomised study assessing high-flow oxygen therapy versus non-invasive ventilation on lung volumes and the upper airway in hypoxemic critically ill patients. BMJ Open. 2025 Sep 16;15(9):e106340. doi: 10.1136/bmjopen-2025-106340. |
Not provided
Not provided
Not provided
12 months after the main publication
Data are provided to qualified investigators free of charge. Required documents to request data include a summary of the research plan, request form, and institutional review board (IRB) review. Dataset will be shared after careful examination by the study board of investigators.
Not provided
Not provided
| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| NIV | Procedure | Patients will receive NIV for 20 minutes delivered with a naso-buccal or face mask according to the patient's tolerance. |
|
| the day of inclusion |
| Variation in Positive End Expiratory Pressure (PEEP) | the day of inclusion |
| Variation in Total lung volume | The total lung volume will be measured by CT-scan | the day of inclusion |
| Variation in O2 gas exchange | Change in PaO2 in mmHg | the day of inclusion |
| Variation in CO2 gas exchange | Change in PaO2 in mmHg | the day of inclusion |
| Variation in respiratory rate | Respiratory rate is the number of cycles per minute | the day of inclusion |
| Variation in cardiac output (Qc) | the cardiac output is in L/min | the day of inclusion |
| 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 |