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

Acute Respiratory Failure Clinical Trial

— FLORALI-IM  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02978300
• Other study ID #: 2016-A00834-47
• Status: Completed
• Phase: N/A
• Start date: January 21, 2017
• Est. completion date: August 30, 2019

Study information

• Verified date: September 2019
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: August 30, 2019
• Est. primary completion date: April 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Immunosuppression
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency

Intervention

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%
• HFNC
Gas flow of 60 l/min and FiO2 set to achieve SpO2 = 92%

Locations

Country	Name	City	State
France	CHU de Poitiers	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

References & Publications (1)

Coudroy R, Frat JP, Ehrmann S, Pène F, Terzi N, Decavèle M, Prat G, Garret C, Contou D, Bourenne J, Gacouin A, Girault C, Dellamonica J, Malacrino D, Labro G, Quenot JP, Herbland A, Jochmans S, Devaquet J, Benzekri D, Vivier E, Nseir S, Colin G, Thévenin D, Grasselli G, Assefi M, Guerin C, Bougon D, Lherm T, Kouatchet A, Ragot S, Thille AW; and the REVA Network. High-flow nasal oxygen therapy alone or with non-invasive ventilation in immunocompromised patients admitted to ICU for acute hypoxemic respiratory failure: the randomised multicentre controlled FLORALI-IM protocol. BMJ Open. 2019 Aug 10;9(8):e029798. doi: 10.1136/bmjopen-2019-029798. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mortality rates	Mortality rates at day 28 after randomization will be compared between the 2 groups	day 28