HONIVAH: Effects of High-flow Oxygen Therapy and Non-invasive Ventilation on Lung Volumes and on Upper Airway
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: HFNC (Hight-flow oxygen therapy) 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%. |
Procedure: HFNC
In the HFNC group, patients will receive HFNC oxygen therapy for 20 minutes.
|
| Active Comparator: Non-invasive ventilation (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%. |
Procedure: NIV
Patients will receive NIV for 20 minutes delivered with a naso-buccal or face mask according to the patient's tolerance.
|
Outcome Measures
Primary Outcome Measures
- 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
- Variation in cross-sectional upper airway area [the day of inclusion]
The variation will be measured by CT-scan in mm
- Variation in normally aerated lung volume [the day of inclusion]
The normally aerated lung volume will be measured by CT scan
- 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 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 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 patient comfort [the day of inclusion]
Patient comfort through a numeric rating scale (NRS) from 0 (no discomfort) to 10 (maximum imaginable discomfort)
Eligibility Criteria
Criteria
Inclusion Criteria:
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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%
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Adult (age ≥ 18 years)
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(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:
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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)
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History of recent facial trauma not compatible with the use of nasal cannulas
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Pregnancy
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Refusal of study participation
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protected person
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Patient not affiliated to the social security system or not benefiting from such a system
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Lack of signed informed consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre Hospitalier Universitaire Montpellier, Saint Eloi | Montpellier | Languedoc-Roussillon | France | 34295 |
Sponsors and Collaborators
- University Hospital, Montpellier
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RECHMPL22_0510