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
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
France
Montpellier University Hospital - Saint Eloi Hospital
RECRUITING
Montpellier
Contact Information
Primary
Samir Jaber, MD, PhD
s-jaber@chu-montpellier.fr
0033467337271
Backup
Audrey DE JONG, MD,PhD
a-de_jong@chu-montpellier.fr
0033467337271
Time Frame
Start Date: 2023-05-23
Estimated Completion Date: 2026-08-23
Participants
Target number of participants: 2100
Treatments
Active_comparator: Standard oxygen therapy
Patients will receive standard oxygen. First attempt device in usual care.
Experimental: High-Flow nasal cannula therapy (HFNO)
Patient will receive HFNO using a humidification system or via the high-flow interface of the ICU ventilator.
Experimental: Noninvasive ventilation therapy (NIV)
Between NIV sessions, patients will receive HFNO with the same modalities than the HFNO group.
Sponsors
Leads: University Hospital, Montpellier

This content was sourced from clinicaltrials.gov