HFNC Alone or Associated With NIV for Immunocompromised Patients Admitted to ICU for Acute Respiratory Failure

Study Overview
=================
Brief Summary
-----------------
Acute respiratory failure is the leading cause of ICU admission of immunocompromized patients. In this subgroup of patients, the need for intubation and invasive mechanical ventilation occurs in about 50% of cases and is associated with very a high mortality rate, reaching 70% of cases. Therefore, noninvasive oxygenation strategies have been developed to avoid intubation. More than 15 years ago, 2 trials have suggested that NIV could decrease intubation and mortality rates of immunocompromized patients as compared to standard oxygen through a mask. However these results have not been confirmed in a recent large trial. HFNC is a recent and well-tolerated oxygenation technique. In a recent trial, HFNC alone could decrease mortality and intubation rates in patients with ARF as compared to NIV. Similar findings have been reported in a post-hoc analysis on immunocompromized patients excluding those with profound neutropenia. Likewise in a retrospective monocentric cohort of immunocompromized patients, we reported better outcomes with HFNC than with NIV.

Official Title
-----------------
High-Flow Nasal Cannula Oxygen Therapy (HFNC) Alone or Associated With Noninvasive Ventilation (NIV) for Immunocompromised Patients Admitted to Intensive Care Unit for Acute Respiratory Failure : FLORALI-Immunodéprimés

Conditions
-----------------
Acute Respiratory Failure, Immunosuppression

Intervention / Treatment
-----------------
* Device: NIV/HFNC
* Device: HFNC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 Admission to ICU for acute respiratory failure defined by all of the following criteria: Dyspnea at rest with RR ≥ 25 breaths/min PaCO2 ≤ 50 mm Hg PaO2/FiO2 ≤ 300 mm Hg under oxygen ≥ 10 l/min through a mask or HFNC or NIV (for patients under oxygen FiO2 will be calculated using the following formula: oxygen flow in liters per minute x 3 + 21) Immunosuppresion defined by 1 of the following criteria: Hematological malignancy (active or remitting < 5 years) Allogenic stem cell transplantation < 5 years Solid cancer (active) Leucopenia < 1 G/l or neutropenia ≤ 0.5 G/l after chemotherapy Solid organ transplantation AIDS (not only HIV) Treatment with immunosuppressive or immunomodulatory drugs Systemic steroids ≥ 0.5 mg/kg/d of prednisone-equivalent for ≥ 3 weeks Non opposition to participate obtained from the patient or their legally acceptable representative. Exclusion Criteria: Contraindication of NIV (patient refusal, cardiac arrest, coma, not drained pneumothorax, unresolving vomiting, upper airways obstruction, hematemesis, severe facial trauma) Chronic respiratory failure with altered pulmonary function tests Overt cardiogenic pulmonary edema Urgent need for intubation Severe shock (vasopressors > 0.3 µg/kg/min to maintain SAP > 90 mm Hg) Impaired consciousness (Glasgow coma scale score ≤ 12) or agitation Surgery under general anesthesia < 7 days Previously included in the trial Do-not-intubate order Pregnancy or breastfeeding Persons benefiting from enhanced protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social institution, adults under legal protection

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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: NIV/HFNC group<br>Continuous NIV for at least 4 hours until clinical improvement then intermittent 1-hour sessions for a minimal duration of 12 hours a day. Between NIV sessions HFNC will be delivered as in the HFNC group. | Device: NIV/HFNC<br>* Pressure support level to achieve an expired tidal volume between 6 and 8 ml/kg of predicted body weight Positive end expiratory pressure from 5 to 10 cm H2O, aiming a PEEP level ≥ 8 cm H2O FiO2 set to achieve SpO2 ≥ 92%<br>|
| Experimental: HFNC group<br>Continuous HFNC alone 24h/24 until weaning or intubation. | Device: HFNC<br>* Gas flow of 60 l/min and FiO2 set to achieve SpO2 ≥ 92%<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality rates | Mortality rates at day 28 after randomization will be compared between the 2 groups | day 28 |