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

Sponsor
Poitiers University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02978300
Collaborator
(none)
300
Enrollment
1
Location
2
Arms
31.2
Actual Duration (Months)
9.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: NIV/HFNC
  • Device: HFNC
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jan 21, 2017
Actual Primary Completion Date :
Apr 2, 2019
Actual Study Completion Date :
Aug 30, 2019

Arms and Interventions

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%

Outcome Measures

Primary Outcome Measures

  1. mortality rates [day 28]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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:

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU de Poitiers Poitiers France 86000

Sponsors and Collaborators

  • Poitiers University Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Poitiers University Hospital
ClinicalTrials.gov Identifier:
NCT02978300
Other Study ID Numbers:
  • 2016-A00834-47
First Posted:
Nov 30, 2016
Last Update Posted:
Sep 4, 2019
Last Verified:
Sep 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Respiratory Insufficiency
Respiratory Distress Syndrome

Study Results

No Results Posted as of Sep 4, 2019