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

NCT02978300 | Completed DMC

• 1 other identifier: 2016-A00834-47
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Respiratory Failure; Immunosuppression

Outcome Measures

Primary Outcomes (1)

• mortality rates

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

  day 28

Study Arms (2)

NIV/HFNC group

ACTIVE COMPARATOR

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.

Device: NIV/HFNC

HFNC group

EXPERIMENTAL

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

Device: HFNC

Interventions

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%

NIV/HFNC group

HFNC DEVICE

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

HFNC group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (1)

CHU de Poitiers

Poitiers, 86000, France

Location

Related Publications (2)

• Coudroy R, Frat JP, Ehrmann S, Pene F, Terzi N, Decavele 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, Thevenin D, Grasselli G, Assefi M, Guerin C, Bougon D, Lherm T, Kouatchet A, Ragot S, Thille AW; 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.

  PMID: 31401603 BACKGROUND

• Coudroy R, Frat JP, Ehrmann S, Pene F, Decavele M, Terzi N, Prat G, Garret C, Contou D, Gacouin A, Bourenne J, Girault C, Vinsonneau C, Dellamonica J, Labro G, Jochmans S, Herbland A, Quenot JP, Devaquet J, Benzekri D, Vivier E, Nseir S, Colin G, Thevenin D, Grasselli G, Bougon D, Assefi M, Guerin C, Lherm T, Kouatchet A, Ragot S, Thille AW; FLORALI-IM study group and the REVA Research Network. High-flow nasal oxygen alone or alternating with non-invasive ventilation in critically ill immunocompromised patients with acute respiratory failure: a randomised controlled trial. Lancet Respir Med. 2022 Jul;10(7):641-649. doi: 10.1016/S2213-2600(22)00096-0. Epub 2022 Mar 21.

  PMID: 35325620 DERIVED

Study Officials

• Rémi Coudroy, M.D.

  Poitiers University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2016
• First Posted: November 30, 2016
• Study Start: January 21, 2017
• Primary Completion: April 2, 2019
• Study Completion: August 30, 2019
• Last Updated: September 4, 2019

Record last verified: 2019-09

Locations

FR (1)