Comparing oxygenation methods for patients with acute respiratory failure
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)
This study is testing whether high-flow nasal cannula oxygen or non-invasive ventilation works better than standard oxygen therapy to help adults with acute respiratory failure live longer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Montpellier Academic / other |
| Locations | 1 site (Montpellier) |
| Trial ID | NCT05812911 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to determine if high-flow nasal cannula oxygen (HFNO) or non-invasive ventilation (NIV) is more effective than standard oxygen therapy in reducing the 28-day mortality rate in patients with hypoxemic acute respiratory failure (ARF). It is a randomized controlled trial with three parallel groups, utilizing a computer-generated allocation sequence for participant randomization. The study will stratify participants based on their medical or surgical status and whether they are immunocompromised. The trial will include adult patients diagnosed with hypoxemic ARF and will assess the effectiveness of the different oxygenation strategies.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with hypoxemic acute respiratory failure.
Not a fit: Patients with contraindications to NIV or HFNO, or those requiring immediate intubation, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective oxygenation strategy that reduces mortality in patients with acute respiratory failure.
How similar studies have performed: Other studies have shown promising results with similar approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Montpellier
- Montpellier University Hospital - Saint Eloi Hospital — Montpellier, France (Recruiting)
Study contacts
- Study coordinator: Samir Jaber, MD, PhD
- Email: s-jaber@chu-montpellier.fr
- Phone: 0033467337271
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.