An Adaptive Randomized Controlled Trial (RCT) Comparing High-flow Nasal Cannula Oxygen and Noninvasive Ventilation to Standard Oxygenation in Non-selected Intensive Care Unit Patients Admitted for Hypoxemic Acute Respiratory Failure: The KISS Trial (Key Oxygenation Interventions in Surgical and Non-Surgical Patients)

University Hospital, Montpellier1 site in 1 country2,100 target enrollmentMay 23, 2023

ConditionsAcute Respiratory Failure

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Acute Respiratory Failure
Sponsor: University Hospital, Montpellier
Enrollment: 2100
Locations: 1
Primary Endpoint: Day-28 mortality
Status: Recruiting
Last Updated: 12 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

May 23, 2023

End Date

August 23, 2026

Last Updated

12 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University Hospital, Montpellier

Responsible Party

Sponsor

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