Comparing High-flow Nasal Cannula Oxygen and Noninvasive Ventilation to Standard Oxygenation in Non-selected ICU Patients Admitted for Hypoxemic ARF

NCT05812911 | Recruiting DMC

• 1 other identifier: RECHMPL20_0031
• Study Type: interventional
• Target: 2,100
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to determine whether one of the two oxygenation or ventilation strategies (NIV and/or HFNO) is superior to standard oxygen to reduce 28-day mortality rate in hypoxemic acute respiratory failure (ARF) patients.

Conditions

Acute Respiratory Failure

Keywords

High-Flow Nasal Cannula Oxygen; Non-Invasive Ventilation; Post-Operative; Immunocompromised; Acute Respiratory Failure; Intensive Care Unit

Outcome Measures

Primary Outcomes (1)

• Day-28 mortality

  Mortality rates at Day-28

  Up to Day-28

Secondary Outcomes (11)

• Intubation rate at Day-28

  Day-28

• Intubation rate at Day-3

  Day-3

• Intubation rate at Day-7

  Day-7

• Oxygenation up to Day-7

  Up to Day-7

• Need of other rescue oxygen therapy up to Day-7

  Up to Day-7

Study Arms (3)

Standard oxygen therapy

ACTIVE COMPARATOR

Patients will receive standard oxygen. First attempt device in usual care.

Procedure: Standard oxygen

High-Flow nasal cannula therapy (HFNO)

EXPERIMENTAL

Patient will receive HFNO using a humidification system or via the high-flow interface of the ICU ventilator.

Procedure: HFNO

Noninvasive ventilation therapy (NIV)

EXPERIMENTAL

Between NIV sessions, patients will receive HFNO with the same modalities than the HFNO group.

Procedure: NIV

Interventions

Standard oxygen PROCEDURE

Standard oxygen therapy administered through a Venturi mask allowing a fraction of inspired oxygen (FiO2) setting to maintain a peripheral oxygen saturation (SpO2) ≥ 94%. For medical reasons left to the clinician appreciation (such as a COPD or pulmonary fibrosis or other conditions), a SpO2 ≥ 90% will be accepted.

Standard oxygen therapy

HFNO PROCEDURE

The oxygen therapy will be administered in a semi-sitting position, with a setting of the FiO2 and the oxygen flow rate, to obtain a SpO2 ≥ 94%. For medical reasons left to the clinician appreciation (such as a COPD or pulmonary fibrosis or other conditions), a SpO2 ≥ 90% will be accepted.

High-Flow nasal cannula therapy (HFNO)

NIV PROCEDURE

Systematic application of NIV using two levels of pressure, pressure support (PS) + positive end-expiratory pressure (PEEP) provided using a dedicated NIV ventilator or a standard ICU ventilator with the " NIV module " through a facial mask. The FiO2 will be set to obtain a SpO2 ≥ 94%. For medical reasons left to the clinician appreciation (such as a COPD or pulmonary fibrosis or other conditions), a SpO2 ≥ 90% will be accepted.

Noninvasive ventilation therapy (NIV)

Eligibility Criteria

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

You may qualify if:

• Adult (age ≥ 18 years)
• A diagnosis of hypoxemic ARF occurring defined as the presence and persistence for more than 30 minutes of hypoxemia (defined by a partial oxygen pressure \<60 mm Hg when breathing room air or \<80 mmHg when breathing 15 L/min of oxygen or a peripheral oxygen saturation \[SpO2\] ≤90% when breathing room air and/or a PaO2(partial pressure of oxygen)/FiO2 ratio \< 300 mmHg plus either \[1\] a respiratory rate higher than 30/min or \[2\] clinical signs suggestive of intense respiratory muscle work and/or labored breathing, such as use of accessory respiratory muscles, paradoxical motion of the abdomen, or intercostal retraction).

You may not qualify if:

• Contraindications to NIV and/or HFNO
• Sleep apnea syndrome with home ventilator
• Immediate tracheal intubation
• Requirement for an emergent surgical procedure requiring intubation
• Hypercapnia with a formal indication for NIV (formal indication for NIV with PaCO2 ≥ 50 mmHg or clinical signs of hypercapnia)
• Isolated cardiogenic pulmonary edema (formal indication for NIV). Patients with pulmonary edema associated with another ARF etiology can be included.
• Anatomical factors precluding the use of NIV and/or HFNO
• Patients with limitation or withdrawal of life-sustaining therapies with a do-not-intubate order
• Pregnancy in progress or planned during the study period or breastfeeding women
• Patients protected by law (Art. L1121-6 and L1121-8 of the Code de la Santé Publique): Adult protected by law or patient under guardianship or curatorship
• Subjects not covered by public health insurance

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Montpellier University Hospital - Saint Eloi Hospital

Montpellier, 34295, France

RECRUITING

Related Publications (1)

• Jaber S, Huguet H, Molinari N, De Jong A. Comparing high-flow nasal cannula oxygen and non-invasive ventilation to standard oxygenation in non-selected intensive care unit patients admitted for acute hypoxaemic respiratory failure: protocol for the KISS (Key oxygenation Interventions in Surgical and non-Surgical patients) adaptive randomised controlled trial. BMJ Open. 2025 Oct 20;15(10):e100149. doi: 10.1136/bmjopen-2025-100149.

  PMID: 41120174 DERIVED

Study Officials

• Samir Jaber, MD, PhD

  Department of anaesthesia and ICU Saint-Eloi Hospital, Montpellier University Hospital

  STUDY DIRECTOR

Central Study Contacts

Samir Jaber, MD, PhD

CONTACT

0033467337271; s-jaber@chu-montpellier.fr

Audrey DE JONG, MD,PhD

CONTACT

0033467337271; a-de_jong@chu-montpellier.fr

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: March 31, 2023
• First Posted: April 14, 2023
• Study Start: May 23, 2023
• Primary Completion (Estimated): May 23, 2026
• Study Completion (Estimated): August 23, 2026
• Last Updated: May 7, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Immediately following publication, no end date.
• Access Criteria: Data will be available for the corresponding author on reasonable request.

Locations

FR (1)