Comparing High-flow Nasal Cannula Oxygen and Noninvasive Ventilation to Standard Oxygenation in Non-selected ICU Patients Admitted for Hypoxemic ARF

Study Overview
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Brief Summary
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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.

Official Title
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An Adaptive Randomized Controlled Trial (RCT) Comparing High-flow Nasal Cannula Oxygen and Noninvasive Ventilation to Standard Oxygenation in Non-selected Intensive Care Unit Patients Admitted for Hypoxemic Acute Respiratory Failure: The KISS Trial (Key Oxygenation Interventions in Surgical and Non-Surgical Patients)

Conditions
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Acute Respiratory Failure

Intervention / Treatment
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* Procedure: Standard oxygen
* Procedure: HFNO
* Procedure: NIV


Participation Criteria
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Eligibility Criteria
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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 requiring intubation Hypercapnia with a formal indication for NIV (formal indication for NIV with PaCO2 ≥ 50 mmHg or clinical signs of hypercapnia) 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 Patients with limitation or withdrawal of life-sustaining therapies with a do-not-intubate order 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard oxygen therapy<br>Patients will receive standard oxygen. First attempt device in usual care. | Procedure: Standard oxygen<br>* Standard oxygen therapy administered through a Venturi mask allowing a fraction of inspired oxygen (FiO2) setting to maintain a peripheral oxygen saturation (SpO2) ≥ 94%. For medical reasons left to the clinician appreciation (such as a COPD or pulmonary fibrosis or other conditions), a SpO2 ≥ 90% will be accepted.<br>|
| Experimental: High-Flow nasal cannula therapy (HFNO)<br>Patient will receive HFNO using a humidification system or via the high-flow interface of the ICU ventilator. | Procedure: HFNO<br>* 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%. For medical reasons left to the clinician appreciation (such as a COPD or pulmonary fibrosis or other conditions), a SpO2 ≥ 90% will be accepted.<br>|
| Experimental: Noninvasive ventilation therapy (NIV)<br>Between NIV sessions, patients will receive HFNO with the same modalities than the HFNO group. | Procedure: NIV<br>* 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%. For medical reasons left to the clinician appreciation (such as a COPD or pulmonary fibrosis or other conditions), a SpO2 ≥ 90% will be accepted.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Day-28 mortality | Mortality rates at Day-28 | Up to Day-28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intubation rate at Day-28 | Proportion of patients requiring invasive mechanical ventilation | Day-28 | 
| Intubation rate at Day-3 | Proportion of patients requiring invasive mechanical ventilation | Day-3 | 
| Intubation rate at Day-7 | Proportion of patients requiring invasive mechanical ventilation | Day-7 | 
| 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 | Mortality rates at Day-90 | Day-90 | 
| Adverse events | Related to the treatment | Up to Day-90 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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High-Flow Nasal Cannula Oxygen, Non-Invasive Ventilation, Post-Operative, Immunocompromised, Acute Respiratory Failure, Intensive Care Unit