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

Poitiers University Hospital

Status: Completed

Conditions: Acute Respiratory Failure; Immunosuppression

Treatments: Device: HFNC; Device: NIV/HFNC

Study type: Interventional

Funder types: Other

Identifiers

NCT02978300

2016-A00834-47

Details and patient eligibility

About

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.

Enrollment: 300 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

NIV/HFNC group

Active Comparator group

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.

Treatment:

Device: NIV/HFNC

HFNC group

Experimental group

Description:

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

Treatment:

Device: HFNC