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

Acute Respiratory Failure Clinical Trial

— KISS  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05812911
• Other study ID #: RECHMPL20_0031
• Status: Recruiting
• Phase: N/A
• Start date: May 23, 2023
• Est. completion date: August 2026

Study information

• Verified date: December 2023
• Source: University Hospital, Montpellier
• Contact: Samir Jaber, MD, PhD
• Phone: 0033467337271
• Email: s-jaber[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2100
• Est. completion date: August 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Respiratory Distress Syndrome
• Respiratory Insufficiency

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
France	Montpellier University Hospital - Saint Eloi Hospital	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Day-28 mortality	Mortality rates at Day-28	Up to Day-28
Secondary	Intubation rate at Day-28	Proportion of patients requiring invasive mechanical ventilation	Day-28
Secondary	Intubation rate at Day-3	Proportion of patients requiring invasive mechanical ventilation	Day-3
Secondary	Intubation rate at Day-7	Proportion of patients requiring invasive mechanical ventilation	Day-7
Secondary	Oxygenation up to Day-7		Up to Day-7
Secondary	Need of other rescue oxygen therapy up to Day-7		Up to Day-7
Secondary	ICU length of stay		Up to Day-90
Secondary	Hospital length of stay		Up to Day-90
Secondary	Mortality rates in ICU		Up to Day-90
Secondary	Mortality rates in hospital		Up to Day-90
Secondary	Day-90 mortality	Mortality rates at Day-90	Day-90
Secondary	Adverse events	Related to the treatment	Up to Day-90