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

NCT ID: NCT05812911

Last Updated: 2025-05-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 2100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-23
• Study Completion Date: 2026-08-23

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.

Detailed Description

This randomized controlled trial is a superiority study to test if one of the methods (NIV and/or HFNO) is superior to standard oxygen in ARF patients requiring oxygen. It is an investigator-initiated, multicenter, adaptive, three arms parallel-group trial with a computer-generated allocation sequence and an electronic system-based randomization, with a stratification on medical (then stratification between immunocompromised and non-immunocompromised patients) versus surgical (then stratification between cardiothoracic and abdominal patients).

Conditions

Acute Respiratory Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard oxygen therapy

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

Group Type: ACTIVE_COMPARATOR

Standard oxygen

Intervention Type: 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.

High-Flow nasal cannula therapy (HFNO)

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

Group Type: EXPERIMENTAL

HFNO

Intervention Type: 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.

Noninvasive ventilation therapy (NIV)

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

Group Type: EXPERIMENTAL

NIV

Intervention Type: 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.

Interventions

Standard oxygen

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.

Intervention Type: PROCEDURE

HFNO

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.

Intervention Type: PROCEDURE

NIV

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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).

Exclusion Criteria

• 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
• Absence of written informed consent from the patient or his or her proxy (if present) before inclusion or when possible when the patient has been included in an emergency setting

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Samir Jaber, MD, PhD

Role: STUDY_DIRECTOR

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

Locations

Montpellier University Hospital - Saint Eloi Hospital

Montpellier, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Samir Jaber, MD, PhD

Role: CONTACT

s-jaber@chu-montpellier.fr

0033467337271

Audrey DE JONG, MD,PhD

Role: CONTACT

a-de_jong@chu-montpellier.fr

0033467337271

Facility Contacts

Samir Jaber, MD, PhD

Role: primary

s-jaber@chu-montpellier.fr

0033467337271

References

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.

Reference Type: DERIVED

PMID: 41120174 (View on PubMed)

Other Identifiers

RECHMPL20_0031

Identifier Type: -

Identifier Source: org_study_id