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

Primary Purpose

Acute Respiratory Failure

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Standard oxygen
HFNO
NIV
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Failure focused on measuring High-Flow Nasal Cannula Oxygen, Non-Invasive Ventilation, Post-Operative, Immunocompromised, Acute Respiratory Failure, Intensive Care Unit

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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 Previous ARF in the last month 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

Sites / Locations

  • Montpellier University Hospital - Saint Eloi HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Standard oxygen therapy

High-Flow nasal cannula therapy (HFNO)

Noninvasive ventilation therapy (NIV)

Arm Description

Patients will receive standard oxygen. First attempt device in usual care.

Patient will receive HFNO using a humidification system or via the high-flow interface of the ICU ventilator.

Between NIV sessions, patients will receive HFNO with the same modalities than the HFNO group.

Outcomes

Primary Outcome Measures

Day-28 mortality
Mortality rates at Day-28

Secondary Outcome Measures

Intubation rate at Day-28
Proportion of patients requiring invasive mechanical ventilation
Intubation rate at Day-3
Proportion of patients requiring invasive mechanical ventilation
Intubation rate at Day-7
Proportion of patients requiring invasive mechanical ventilation
Oxygenation up to Day-7
Need of other rescue oxygen therapy up to Day-7
ICU length of stay
Hospital length of stay
Mortality rates in ICU
Mortality rates in hospital
Day-90 mortality
Mortality rates at Day-90
Adverse events
Related to the treatment

Full Information

First Posted
March 31, 2023
Last Updated
May 23, 2023
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT05812911
Brief Title
Comparing High-flow Nasal Cannula Oxygen and Noninvasive Ventilation to Standard Oxygenation in Non-selected ICU Patients Admitted for Hypoxemic ARF
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 23, 2023 (Actual)
Primary Completion Date
May 2026 (Anticipated)
Study Completion Date
August 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Failure
Keywords
High-Flow Nasal Cannula Oxygen, Non-Invasive Ventilation, Post-Operative, Immunocompromised, Acute Respiratory Failure, Intensive Care Unit

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard oxygen therapy
Arm Type
Active Comparator
Arm Description
Patients will receive standard oxygen. First attempt device in usual care.
Arm Title
High-Flow nasal cannula therapy (HFNO)
Arm Type
Experimental
Arm Description
Patient will receive HFNO using a humidification system or via the high-flow interface of the ICU ventilator.
Arm Title
Noninvasive ventilation therapy (NIV)
Arm Type
Experimental
Arm Description
Between NIV sessions, patients will receive HFNO with the same modalities than the HFNO group.
Intervention Type
Procedure
Intervention Name(s)
Standard oxygen
Intervention Description
Standard oxygen therapy administered through a Venturi mask allowing a fraction of inspired oxygen (FiO2) setting to maintain a peripheral oxygen saturation (SpO2) ≥ 94%.
Intervention Type
Procedure
Intervention Name(s)
HFNO
Intervention Description
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%.
Intervention Type
Procedure
Intervention Name(s)
NIV
Intervention Description
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%.
Primary Outcome Measure Information:
Title
Day-28 mortality
Description
Mortality rates at Day-28
Time Frame
Up to Day-28
Secondary Outcome Measure Information:
Title
Intubation rate at Day-28
Description
Proportion of patients requiring invasive mechanical ventilation
Time Frame
Day-28
Title
Intubation rate at Day-3
Description
Proportion of patients requiring invasive mechanical ventilation
Time Frame
Day-3
Title
Intubation rate at Day-7
Description
Proportion of patients requiring invasive mechanical ventilation
Time Frame
Day-7
Title
Oxygenation up to Day-7
Time Frame
Up to Day-7
Title
Need of other rescue oxygen therapy up to Day-7
Time Frame
Up to Day-7
Title
ICU length of stay
Time Frame
Up to Day-90
Title
Hospital length of stay
Time Frame
Up to Day-90
Title
Mortality rates in ICU
Time Frame
Up to Day-90
Title
Mortality rates in hospital
Time Frame
Up to Day-90
Title
Day-90 mortality
Description
Mortality rates at Day-90
Time Frame
Day-90
Title
Adverse events
Description
Related to the treatment
Time Frame
Up to Day-90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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 Previous ARF in the last month 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Samir Jaber, MD, PhD
Phone
0033467337271
Email
s-jaber@chu-montpellier.fr
Facility Information:
Facility Name
Montpellier University Hospital - Saint Eloi Hospital
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samir Jaber, MD, PhD
Phone
0033467337271
Email
s-jaber@chu-montpellier.fr
First Name & Middle Initial & Last Name & Degree
Samir Jaber, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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