KISS: Comparing High-flow Nasal Cannula Oxygen and Noninvasive Ventilation to Standard Oxygenation in Non-selected ICU Patients Admitted for Hypoxemic ARF
Study Details
Study Description
Brief Summary
The goal of this clinical trial is to determine whether one of the two oxygenation or ventilation strategies (NIV and/or HFNO) is superior to standard oxygen to reduce 28-day mortality rate in hypoxemic acute respiratory failure (ARF) patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Standard oxygen therapy Patients will receive standard oxygen. First attempt device in usual care. |
Procedure: Standard oxygen
Standard oxygen therapy administered through a Venturi mask allowing a fraction of inspired oxygen (FiO2) setting to maintain a peripheral oxygen saturation (SpO2) ≥ 94%.
|
| Experimental: High-Flow nasal cannula therapy (HFNO) Patient will receive HFNO using a humidification system or via the high-flow interface of the ICU ventilator. |
Procedure: HFNO
The oxygen therapy will be administered in a semi-sitting position, with a setting of the FiO2 and the oxygen flow rate, to obtain a SpO2 ≥ 94%.
|
| Experimental: Noninvasive ventilation therapy (NIV) Between NIV sessions, patients will receive HFNO with the same modalities than the HFNO group. |
Procedure: NIV
Systematic application of NIV using two levels of pressure, pressure support (PS) + positive end-expiratory pressure (PEEP) provided using a dedicated NIV ventilator or a standard ICU ventilator with the " NIV module " through a facial mask. The FiO2 will be set to obtain a SpO2 ≥ 94%.
|
Outcome Measures
Primary Outcome Measures
- Day-28 mortality [Up to Day-28]
Mortality rates at Day-28
Secondary Outcome Measures
- Intubation rate at Day-28 [Day-28]
Proportion of patients requiring invasive mechanical ventilation
- Intubation rate at Day-3 [Day-3]
Proportion of patients requiring invasive mechanical ventilation
- Intubation rate at Day-7 [Day-7]
Proportion of patients requiring invasive mechanical ventilation
- Oxygenation up to Day-7 [Up to Day-7]
- Need of other rescue oxygen therapy up to Day-7 [Up to Day-7]
- ICU length of stay [Up to Day-90]
- Hospital length of stay [Up to Day-90]
- Mortality rates in ICU [Up to Day-90]
- Mortality rates in hospital [Up to Day-90]
- Day-90 mortality [Day-90]
Mortality rates at Day-90
- Adverse events [Up to Day-90]
Related to the treatment
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Adult (age ≥ 18 years)
-
A diagnosis of hypoxemic ARF occurring defined as the presence and persistence for more than 30 minutes of hypoxemia (defined by a partial oxygen pressure <60 mm Hg when breathing room air or <80 mmHg when breathing 15 L/min of oxygen or a peripheral oxygen saturation [SpO2] ≤90% when breathing room air and/or a PaO2(partial pressure of oxygen)/FiO2 ratio < 300 mmHg plus either [1] a respiratory rate higher than 30/min or [2] clinical signs suggestive of intense respiratory muscle work and/or labored breathing, such as use of accessory respiratory muscles, paradoxical motion of the abdomen, or intercostal retraction).
Exclusion Criteria:
-
Contraindications to NIV and/or HFNO
-
Sleep apnea syndrome with home ventilator
-
Immediate tracheal intubation
-
Requirement for an emergent surgical procedure
-
Hypercapnia with a formal indication for NIV (Partial pressure of carbon dioxide (PaCO2) ≥ 50 mmHg, formal indication for NIV)
-
Isolated cardiogenic pulmonary edema (formal indication for NIV). Patients with pulmonary edema associated with another ARF etiology can be included.
-
Anatomical factors precluding the use of NIV and/or HFNO
-
Previous ARF in the last month
-
Pregnancy in progress or planned during the study period or breastfeeding women
-
Patients protected by law (Art. L1121-6 and L1121-8 of the Code de la Santé Publique): Adult protected by law or patient under guardianship or curatorship
-
Subjects not covered by public health insurance
-
Absence of written informed consent from the patient or his or her proxy (if present) before inclusion or when possible when the patient has been included in an emergency setting
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Montpellier University Hospital - Saint Eloi Hospital | Montpellier | France | 34295 |
Sponsors and Collaborators
- University Hospital, Montpellier
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RECHMPL20_0031