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

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.

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Key information

Conditions

Acute Respiratory Failure Immunosuppression

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Poitiers

Poitiers, 86000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NIV/HFNC

Device

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%

HFNC

Device

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

Primary outcomes

mortality rates

Time frame: day 28

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

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Official study 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

Acronym: FLORALI-IM

Important dates

Study start: 2017
Primary completion: 2019
Study completion: 2019
First posted: Nov 30, 2016
Registry last updated: Sep 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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