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

Not Applicable

Completed

• Conditions: Acute Respiratory Failure; Immunosuppression
• Interventions: Device: HFNC; Device: NIV/HFNC

• Registration Number: NCT02978300
• Lead Sponsor: Poitiers University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-24
• Study First Submitted QC: 2016-11-28
• Study First Posted: 2016-11-30
• Study Start: 2017-01-21
• Primary Completion: 2019-04-02
• Study Completion: 2019-08-30
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-02
• Last Update Posted: 2019-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HFNC group	HFNC	Continuous HFNC alone 24h/24 until weaning or intubation.
NIV/HFNC group	NIV/HFNC	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

CHU de Poitiers; 🇫🇷 Poitiers, France