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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Acute Respiratory Failure
- Sponsor
- Poitiers University Hospital
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- mortality rates
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
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
Outcomes
Primary Outcomes
mortality rates
Time Frame: day 28
Mortality rates at day 28 after randomization will be compared between the 2 groups