NCT05812911

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

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)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,100 (estimated)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	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.
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.
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.

Timeline

• Start date: 2023-05-23
• Primary completion: 2026-05-23
• Completion: 2026-08-23
• First posted: 2023-04-14
• Last updated: 2025-05-07

Locations

1 site across 1 country: France