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CompletedNCT02978300FLORALI-IMUpdated Sep 4, 2019

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

An interventional study of NIV/HFNC and HFNC in Acute Respiratory Failure and Immunosuppression, sponsored by Poitiers University Hospital. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-04.

Sponsored by Poitiers University Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Acute Respiratory Failure
  • Immunosuppression
03

In context

Respiratory Insufficiency

1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.

This study's enrollment of 300 is above the median of 55 across 1,043 interventional studies indexed under Respiratory Insufficiency.

Browse Respiratory Insufficiency studies →

Lead sponsor

Poitiers University Hospital is the lead sponsor of 310 studies on the registry; 64 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
300 participants (actual)

Study arms

  • 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

  • Experimental
    HFNC group

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

    Device: HFNC

Interventions

  • DeviceNIV/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%

  • DeviceHFNC

    Gas flow of 60 l/min and FiO2 set to achieve SpO2 ≥ 92%

06

What researchers measure

Primary outcomes

  1. mortality rates

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

    Time frame: day 28

07

Study locations

1 site
  • CHU de Poitiers
    Poitiers, 86000, France
08

References and documents

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. PubMed 31401603 ↗
  • 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. PubMed 35325620 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 4, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02978300
Lead sponsor
Poitiers University Hospital
Responsible party
Sponsor
First posted
Nov 30, 2016
Start date
Jan 21, 2017
Primary completion
Apr 2, 2019
Completion
Aug 30, 2019
Last update
Sep 4, 2019

Study contacts

Rémi Coudroy, M.D.
study director · Poitiers University Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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