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

Primary Purpose

Acute Respiratory Failure, Immunosuppression

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
NIV/HFNC
HFNC
Sponsored by
Poitiers University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Poitiers

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

NIV/HFNC group

HFNC group

Arm Description

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.

Continuous HFNC alone 24h/24 until weaning or intubation.

Outcomes

Primary Outcome Measures

mortality rates
Mortality rates at day 28 after randomization will be compared between the 2 groups

Secondary Outcome Measures

Full Information

First Posted
November 24, 2016
Last Updated
September 2, 2019
Sponsor
Poitiers University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02978300
Brief Title
HFNC Alone or Associated With NIV for Immunocompromised Patients Admitted to ICU for Acute Respiratory Failure
Acronym
FLORALI-IM
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
January 21, 2017 (Actual)
Primary Completion Date
April 2, 2019 (Actual)
Study Completion Date
August 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Failure, Immunosuppression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NIV/HFNC group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
HFNC group
Arm Type
Experimental
Arm Description
Continuous HFNC alone 24h/24 until weaning or intubation.
Intervention Type
Device
Intervention Name(s)
NIV/HFNC
Intervention Description
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%
Intervention Type
Device
Intervention Name(s)
HFNC
Intervention Description
Gas flow of 60 l/min and FiO2 set to achieve SpO2 ≥ 92%
Primary Outcome Measure Information:
Title
mortality rates
Description
Mortality rates at day 28 after randomization will be compared between the 2 groups
Time Frame
day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rémi Coudroy, M.D.
Organizational Affiliation
Poitiers University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
CHU de Poitiers
City
Poitiers
ZIP/Postal Code
86000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31401603
Citation
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.
Results Reference
background
PubMed Identifier
35325620
Citation
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.
Results Reference
derived

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

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