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

University Hospital Center (CHU)

Status: Enrolling

Conditions: Acute Respiratory Failure

Treatments: Procedure: NIV; Procedure: HFNO; Procedure: Standard oxygen

Study type: Interventional

Funder types: Other

Identifiers

NCT05812911

RECHMPL20_0031

Details and patient eligibility

About

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.

Full 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).

Enrollment: 2,100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,100 participants in 3 patient groups

Standard oxygen therapy

Active Comparator group

Description:

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

Treatment:

Procedure: Standard oxygen

High-Flow nasal cannula therapy (HFNO)

Experimental group

Description:

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

Treatment:

Procedure: HFNO

Noninvasive ventilation therapy (NIV)

Experimental group

Description:

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

Treatment:

Procedure: NIV