Clinical trial NCT05812911: Comparing High-flow Nasal Cannula Oxygen and Noninvasive Ventilation to Standard Oxygenation in Non-selected ICU Patients Admitted for Hypoxemic ARF
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Respiratory Failure
Keywords: High-Flow Nasal Cannula Oxygen
Non-Invasive Ventilation
Post-Operative
Immunocompromised
Acute Respiratory Failure
Intensive Care Unit
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2023-04-14
Enrollment: 2100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Day-28 mortality
timeFrame: Up to Day-28
Secondary outcomes:
measure: Intubation rate at Day-28
timeFrame: Day-28
measure: Intubation rate at Day-3
timeFrame: Day-3
measure: Intubation rate at Day-7
timeFrame: Day-7
measure: Oxygenation up to Day-7
timeFrame: Up to Day-7
measure: Need of other rescue oxygen therapy up to Day-7
timeFrame: Up to Day-7
measure: ICU length of stay
timeFrame: Up to Day-90
measure: Hospital length of stay
timeFrame: Up to Day-90
measure: Mortality rates in ICU
timeFrame: Up to Day-90
measure: Mortality rates in hospital
timeFrame: Up to Day-90
measure: Day-90 mortality
timeFrame: Day-90
measure: Adverse events
timeFrame: Up to Day-90
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Montpellier University Hospital - Saint Eloi Hospital
Study officials:
affiliation: Department of anaesthesia and ICU Saint-Eloi Hospital, Montpellier University Hospital
name: Samir Jaber, MD, PhD
role: STUDY_DIRECTOR
References: