Acute Respiratory FailureKISSNCT05812911
Comparing High-flow Nasal Cannula Oxygen and Noninvasive Ventilation to Standard Oxygenation in Non-selected ICU Patients Admitted for Hypoxemic ARF
A study testing Standard oxygen, HFNO and NIV in people with Acute Respiratory Failure, run by University Hospital, Montpellier at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure
- What is being tested?
- Standard oxygen, HFNO and NIV
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,470 participants
- Where
- 1 siteFrance
- Study dates
- 23 May 2023to 15 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Montpellier University Hospital - Saint Eloi Hospital
Montpellier, 34295
About this study
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)
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.
Read the 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
- Being tested
- Standard oxygen, HFNO, NIV
- Keywords
- High-Flow Nasal Cannula Oxygen, Non-Invasive Ventilation, Post-Operative, Immunocompromised, Acute Respiratory Failure, Intensive Care Unit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard oxygenProcedure or surgery
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.
HFNOProcedure or surgery
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.
NIVProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard oxygen therapy | Active comparator | Patients will receive standard oxygen. First attempt device in usual care. Receives: Procedure: Standard oxygen |
| High-Flow nasal cannula therapy (HFNO) | Experimental | Patient will receive HFNO using a humidification system or via the high-flow interface of the ICU ventilator. Receives: Procedure: HFNO |
| Noninvasive ventilation therapy (NIV) | Experimental | Between NIV sessions, patients will receive HFNO with the same modalities than the HFNO group. Receives: Procedure: NIV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Day-28 mortality
Mortality rates at Day-28
Measured: Up to Day-28
Secondary outcomes (11)
Intubation rate at Day-28
Proportion of patients requiring invasive mechanical ventilation
Measured: Day-28
Intubation rate at Day-3
Proportion of patients requiring invasive mechanical ventilation
Measured: Day-3
Intubation rate at Day-7
Proportion of patients requiring invasive mechanical ventilation
Measured: Day-7
Oxygenation up to Day-7
Proportion of patients with better oxygenation
Measured: Up to Day-7
Need of other rescue oxygen therapy up to Day-7
Proportion of patients requiring rescue oxygen therapy
Measured: Up to Day-7
ICU length of stay
Duration time in ICU
Measured: Up to Day-90
Hospital length of stay
Duration time in Hospital
Measured: Up to Day-90
Mortality rates in ICU
Mortality rates in ICU
Measured: Up to Day-90
Mortality rates in hospital
Mortality rates in hospital
Measured: Up to Day-90
Day-90 mortality
Mortality rates at Day-90
Measured: Day-90
Adverse events
Related to the treatment
Measured: Up to Day-90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study start23 May 2023
- Primary completion14 Mar 2026
- Study completion15 May 2026
Why it stopped: At th second interim analysis, the DSMB recommended discontinuation of the trial for futility. The sponsor took this recommendation into account and decided to prematurely terminate the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory FailureStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,470 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samir Jaber, MD, PhD, Study director, Department of anaesthesia and ICU Saint-Eloi Hospital, Montpellier University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05812911
- Sponsor's protocol ID
- RECHMPL20_0031
- Acronym
- KISS
- Status last verified
- Jun 2026
- First submitted
- 31 Mar 2023
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only the statisticians will have access to the full trial dataset during the enrolment period. All data will be made available to the coordinator at the end of inclusion. Controlled access will be granted to participant-level data sets. Technical appendix, statistical code, and dataset will be available on demand.
Publications
Jaber S, Huguet H, Molinari N, De Jong A. Comparing high-flow nasal cannula oxygen and non-invasive ventilation to standard oxygenation in non-selected intensive care unit patients admitted for acute hypoxaemic respiratory failure: protocol for the KISS (Key oxygenation Interventions in Surgical and non-Surgical patients) adaptive randomised controlled trial. BMJ Open. 2025 Oct 20;15(10):e100149. doi: 10.1136/bmjopen-2025-100149.
PubMed 41120174Jaber S, Pensier J, Futier E, Paugam-Burtz C, Seguin P, Ferrandiere M, Lasocki S, Pottecher J, Abback PS, Riu B, Belafia F, Constantin JM, Verzilli D, Chanques G, De Jong A, Molinari N; NIVAS Study Group. Noninvasive ventilation on reintubation in patients with obesity and hypoxemic respiratory failure following abdominal surgery: a post hoc analysis of a randomized clinical trial. Intensive Care Med. 2024 Aug;50(8):1265-1274. doi: 10.1007/s00134-024-07522-4. Epub 2024 Jul 29.
PubMed 39073580
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05812911
- Acronym / sponsor ID
- KISS / RECHMPL20_0031
- Conditions
- Acute Respiratory Failure
- Keywords
- High-Flow Nasal Cannula Oxygen, Non-Invasive Ventilation, Post-Operative, Immunocompromised, Acute Respiratory Failure, Intensive Care Unit
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: At th second interim analysis, the DSMB recommended discontinuation of the trial for futility. The sponsor took this recommendation into account and decided to prematurely terminate the study
- Enrolment
- 1,470 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 23 May 2023 (actual)
- Primary completion
- 14 Mar 2026 (actual)
- Study completion
- 15 May 2026 (actual)
- First posted
- 14 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard oxygen therapy | Active comparator | Procedure: Standard oxygenPatients will receive standard oxygen. First attempt device in usual care. |
| High-Flow nasal cannula therapy (HFNO) | Experimental | Procedure: HFNOPatient will receive HFNO using a humidification system or via the high-flow interface of the ICU ventilator. |
| Noninvasive ventilation therapy (NIV) | Experimental | Procedure: NIVBetween NIV sessions, patients will receive HFNO with the same modalities than the HFNO group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard oxygenStandard 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 or surgery | Standard oxygen therapy |
| HFNOThe 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 or surgery | High-Flow nasal cannula therapy (HFNO) |
| NIVSystematic 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. | Procedure or surgery | Noninvasive ventilation therapy (NIV) |
Primary outcome
Day-28 mortality
Time frame: Up to Day-28
Mortality rates at Day-28
11 secondary outcomes
Intubation rate at Day-28
Time frame: Day-28
Intubation rate at Day-3
Time frame: Day-3
Intubation rate at Day-7
Time frame: Day-7
Oxygenation up to Day-7
Time frame: Up to Day-7
Need of other rescue oxygen therapy up to Day-7
Time frame: Up to Day-7
ICU length of stay
Time frame: Up to Day-90
Hospital length of stay
Time frame: Up to Day-90
Mortality rates in ICU
Time frame: Up to Day-90
Mortality rates in hospital
Time frame: Up to Day-90
Day-90 mortality
Time frame: Day-90
Adverse events
Time frame: Up to Day-90
Results and safety
The study was stopped early (reason given: At th second interim analysis, the DSMB recommended discontinuation of the trial for futility. The sponsor took this recommendation into account and decided to prematurely terminate the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Derived from this study: PubMed 41120174Jaber S, Huguet H, Molinari N, De Jong A. Comparing high-flow nasal cannula oxygen and non-invasive ventilation to standard oxygenation in non-selected intensive care unit patients admitted for acute hypoxaemic respiratory failure: protocol for the KISS (Key oxygenation Interventions in Surgical and non-Surgical patients) adaptive randomised controlled trial. BMJ Open. 2025 Oct 20;15(10):e100149. doi: 10.1136/bmjopen-2025-100149.
- Derived from this study: PubMed 39073580Jaber S, Pensier J, Futier E, Paugam-Burtz C, Seguin P, Ferrandiere M, Lasocki S, Pottecher J, Abback PS, Riu B, Belafia F, Constantin JM, Verzilli D, Chanques G, De Jong A, Molinari N; NIVAS Study Group. Noninvasive ventilation on reintubation in patients with obesity and hypoxemic respiratory failure following abdominal surgery: a post hoc analysis of a randomized clinical trial. Intensive Care Med. 2024 Aug;50(8):1265-1274. doi: 10.1007/s00134-024-07522-4. Epub 2024 Jul 29.
- Individual participant dataSharing planned: Yes. Only the statisticians will have access to the full trial dataset during the enrolment period. All data will be made available to the coordinator at the end of inclusion. Controlled access will be granted to participant-level data sets. Technical appendix, statistical code, and dataset will be available on demand.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samir Jaber, MD, PhD study director
Department of anaesthesia and ICU Saint-Eloi Hospital, Montpellier University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard oxygen, HFNO and NIV in people with Acute Respiratory Failure, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: At th second interim analysis, the DSMB recommended discontinuation of the trial for futility. The sponsor took this recommendation into account and decided to prematurely terminate the study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Day-28 mortality (time frame: Up to Day-28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05812911, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.