HFNC Alone or Associated With NIV for Immunocompromised Patients Admitted to ICU for Acute Respiratory Failure (FLORALI-IM)

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

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.

Study Overview

• Status: Completed
• Conditions: Immunosuppression; Acute Respiratory Failure
• Intervention / Treatment: Device: NIV/HFNC; Device: HFNC

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Poitiers, France, 86000
    • CHU de Poitiers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: NIV/HFNC group; 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; 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%
Experimental: HFNC group; Continuous HFNC alone 24h/24 until weaning or intubation.	Device: HFNC; Gas flow of 60 l/min and FiO2 set to achieve SpO2 ≥ 92%

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

Collaborators and Investigators

• Sponsor: Poitiers University Hospital
• Investigators: Study Director: Rémi Coudroy, M.D., Poitiers University Hospital

Publications and helpful links

General Publications

• Coudroy R, Frat JP, Ehrmann S, Pene F, Terzi N, Decavele M, Prat G, Garret C, Contou D, Bourenne J, Gacouin A, Girault C, Dellamonica J, Malacrino D, Labro G, Quenot JP, Herbland A, Jochmans S, Devaquet J, Benzekri D, Vivier E, Nseir S, Colin G, Thevenin D, Grasselli G, Assefi M, Guerin C, Bougon D, Lherm T, Kouatchet A, Ragot S, Thille AW; REVA Network. High-flow nasal oxygen therapy alone or with non-invasive ventilation in immunocompromised patients admitted to ICU for acute hypoxemic respiratory failure: the randomised multicentre controlled FLORALI-IM protocol. BMJ Open. 2019 Aug 10;9(8):e029798. doi: 10.1136/bmjopen-2019-029798.
• Coudroy R, Frat JP, Ehrmann S, Pene F, Decavele M, Terzi N, Prat G, Garret C, Contou D, Gacouin A, Bourenne J, Girault C, Vinsonneau C, Dellamonica J, Labro G, Jochmans S, Herbland A, Quenot JP, Devaquet J, Benzekri D, Vivier E, Nseir S, Colin G, Thevenin D, Grasselli G, Bougon D, Assefi M, Guerin C, Lherm T, Kouatchet A, Ragot S, Thille AW; FLORALI-IM study group and the REVA Research Network. High-flow nasal oxygen alone or alternating with non-invasive ventilation in critically ill immunocompromised patients with acute respiratory failure: a randomised controlled trial. Lancet Respir Med. 2022 Jul;10(7):641-649. doi: 10.1016/S2213-2600(22)00096-0. Epub 2022 Mar 21.

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2017
• Primary Completion (Actual): April 2, 2019
• Study Completion (Actual): August 30, 2019

Study Registration Dates

• First Submitted: November 24, 2016
• First Submitted That Met QC Criteria: November 28, 2016
• First Posted (Estimate): November 30, 2016

Study Record Updates

• Last Update Posted (Actual): September 4, 2019
• Last Update Submitted That Met QC Criteria: September 2, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Respiratory Insufficiency; Respiratory Distress Syndrome
• Other Study ID Numbers: 2016-A00834-47

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No