Back to resultsEffects of High-flow Oxygen Therapy and Non-invasive Ventilation on Lung Volumes and on Upper Airway (HONIVAH)
Primary Purpose
Respiratory Failure
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
HFNC
NIV
Sponsored by
About this trial
This is an interventional treatment trial for Respiratory Failure focused on measuring intensive care, non-invasive ventilation, high-flow nasal oxygen therapy, hypoxemic respiratory failure, upper airway
Eligibility Criteria
Inclusion Criteria: Patient with hypoxemia at any time of ICU stay defined as follow: standard oxygen therapy flow ≥ 3L/min to maintain a pulsed oxygen saturation ≥ 95% Adult (age ≥ 18 years) (2) A CT scan prescribed by the physician in charge of the patient as part of the exploration of the patient's pathology and not as part of a "dedicated" prescription for the study. Exclusion Criteria: NIV contraindication (need for immediate endotracheal intubation and mechanical ventilation; hemodynamic instability defined by systolic blood pressure < 90 mmHg or mean blood pressure < 65 mmHg, use of vasopressors; Glasgow Coma Scale score of 12 points or less) History of recent facial trauma not compatible with the use of nasal cannulas Pregnancy Refusal of study participation protected person Patient not affiliated to the social security system or not benefiting from such a system Lack of signed informed consent
Sites / Locations
- Centre Hospitalier Universitaire Montpellier, Saint EloiRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
HFNC (Hight-flow oxygen therapy)
Non-invasive ventilation (NIV)
Arm Description
In the HFNC group, patients will receive HFNC oxygen therapy for 20 minutes. Oxygen will be passed through a heated humidifier and continuously delivered through medium or large nasal cannulas (OptiflowTM, Fisher and Paykel Healthcare) depending on patient anatomy, with a gas flow of 50 litres per minute and the FiO2 will be adjusted to maintain a SpO2 between 95% and 98%.
In the NIV Group, patients will receive NIV for 20 minutes delivered with a naso-buccal or face mask according to the patient's tolerance. The pressure-support level will be adjusted with the aim of an expired tidal volume of 6 to 8 ml per kilogram of predicted body weight, with a positive end-expiratory pressure (PEEP) of 5 cmH2O. The FiO2 will be adjusted to maintain a SpO2 between 95% and 98%.
Outcomes
Primary Outcome Measures
Variation in poorly aerated lung volume
The poorly aerated volume will be measured by CT scan
Variation in non-aereted lung volume
The non-aereted volume will be measured by CT scan
Secondary Outcome Measures
Variation in cross-sectional upper airway area
The variation will be measured by CT-scan in mm
Variation in normally aerated lung volume
The normally aerated lung volume will be measured by CT scan
Variation in Positive End Expiratory Pressure (PEEP)
Variation in Total lung volume
The total lung volume will be measured by CT-scan
Variation in O2 gas exchange
Change in PaO2 in mmHg
Variation in CO2 gas exchange
Change in PaO2 in mmHg
Variation in respiratory rate
Respiratory rate is the number of cycles per minute
Variation in cardiac output (Qc)
the cardiac output is in L/min
Variation in patient comfort
Patient comfort through a numeric rating scale (NRS) from 0 (no discomfort) to 10 (maximum imaginable discomfort)
Full Information
NCT ID
NCT05643911
First Posted
November 17, 2022
Last Updated
January 31, 2023
Sponsor
University Hospital, Montpellier
1. Study Identification
Unique Protocol Identification Number
NCT05643911
Brief Title
Effects of High-flow Oxygen Therapy and Non-invasive Ventilation on Lung Volumes and on Upper Airway
Acronym
HONIVAH
Official Title
Effects of High-flow Oxygen Therapy and Non-invasive Ventilation on Lung Volumes and on Upper Airway in Hypoxemic Critical Care Patients: a Physiological Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 27, 2023 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
January 2025 (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
No
5. Study Description
Brief Summary
Respiratory failure is the most frequent organ failure and cause for admission in the Intensive Care Unit (ICU) . It is a severe complication with an ICU mortality ranged from 31% to 33%. Symptomatic treatment of hypoxemic respiratory failure is a controversial topic with different options: 1) standard oxygen therapy, 2) high flow nasal cannula oxygen therapy (HFNC) and 3) non-invasive ventilation (NIV).
The aim of the study is to compare HFNC versus NIV ventilation using CT scan. The hypothesis of this study is that in hypoxemic critically ill patients, the increase of lung volumes with NIV would be significantly higher than the increase of lung volumes with HFNC.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure
Keywords
intensive care, non-invasive ventilation, high-flow nasal oxygen therapy, hypoxemic respiratory failure, upper airway
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
56 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HFNC (Hight-flow oxygen therapy)
Arm Type
Experimental
Arm Description
In the HFNC group, patients will receive HFNC oxygen therapy for 20 minutes. Oxygen will be passed through a heated humidifier and continuously delivered through medium or large nasal cannulas (OptiflowTM, Fisher and Paykel Healthcare) depending on patient anatomy, with a gas flow of 50 litres per minute and the FiO2 will be adjusted to maintain a SpO2 between 95% and 98%.
Arm Title
Non-invasive ventilation (NIV)
Arm Type
Active Comparator
Arm Description
In the NIV Group, patients will receive NIV for 20 minutes delivered with a naso-buccal or face mask according to the patient's tolerance. The pressure-support level will be adjusted with the aim of an expired tidal volume of 6 to 8 ml per kilogram of predicted body weight, with a positive end-expiratory pressure (PEEP) of 5 cmH2O. The FiO2 will be adjusted to maintain a SpO2 between 95% and 98%.
Intervention Type
Procedure
Intervention Name(s)
HFNC
Intervention Description
In the HFNC group, patients will receive HFNC oxygen therapy for 20 minutes.
Intervention Type
Procedure
Intervention Name(s)
NIV
Intervention Description
Patients will receive NIV for 20 minutes delivered with a naso-buccal or face mask according to the patient's tolerance.
Primary Outcome Measure Information:
Title
Variation in poorly aerated lung volume
Description
The poorly aerated volume will be measured by CT scan
Time Frame
the day of inclusion
Title
Variation in non-aereted lung volume
Description
The non-aereted volume will be measured by CT scan
Time Frame
the day of inclusion
Secondary Outcome Measure Information:
Title
Variation in cross-sectional upper airway area
Description
The variation will be measured by CT-scan in mm
Time Frame
the day of inclusion
Title
Variation in normally aerated lung volume
Description
The normally aerated lung volume will be measured by CT scan
Time Frame
the day of inclusion
Title
Variation in Positive End Expiratory Pressure (PEEP)
Time Frame
the day of inclusion
Title
Variation in Total lung volume
Description
The total lung volume will be measured by CT-scan
Time Frame
the day of inclusion
Title
Variation in O2 gas exchange
Description
Change in PaO2 in mmHg
Time Frame
the day of inclusion
Title
Variation in CO2 gas exchange
Description
Change in PaO2 in mmHg
Time Frame
the day of inclusion
Title
Variation in respiratory rate
Description
Respiratory rate is the number of cycles per minute
Time Frame
the day of inclusion
Title
Variation in cardiac output (Qc)
Description
the cardiac output is in L/min
Time Frame
the day of inclusion
Title
Variation in patient comfort
Description
Patient comfort through a numeric rating scale (NRS) from 0 (no discomfort) to 10 (maximum imaginable discomfort)
Time Frame
the day of inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient with hypoxemia at any time of ICU stay defined as follow: standard oxygen therapy flow ≥ 3L/min to maintain a pulsed oxygen saturation ≥ 95%
Adult (age ≥ 18 years)
(2) A CT scan prescribed by the physician in charge of the patient as part of the exploration of the patient's pathology and not as part of a "dedicated" prescription for the study.
Exclusion Criteria:
NIV contraindication (need for immediate endotracheal intubation and mechanical ventilation; hemodynamic instability defined by systolic blood pressure < 90 mmHg or mean blood pressure < 65 mmHg, use of vasopressors; Glasgow Coma Scale score of 12 points or less)
History of recent facial trauma not compatible with the use of nasal cannulas
Pregnancy
Refusal of study participation
protected person
Patient not affiliated to the social security system or not benefiting from such a system
Lack of signed informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Samir JABER
Phone
0033467337271
Email
s-jaber@chu-montpellier.fr
Facility Information:
Facility Name
Centre Hospitalier Universitaire Montpellier, Saint Eloi
City
Montpellier
State/Province
Languedoc-Roussillon
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samir JABER, MD, PhD
Phone
+33467337271
Email
s-jaber@chu-montpellier.fr
First Name & Middle Initial & Last Name & Degree
Samir JABER, MD, PhD
First Name & Middle Initial & Last Name & Degree
Audrey De JONG, MD
First Name & Middle Initial & Last Name & Degree
Clément MONET, MD
First Name & Middle Initial & Last Name & Degree
Matthieu CONSEIL, MD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Time Frame
12 months after the main publication
IPD Sharing Access Criteria
Data are provided to qualified investigators free of charge. Required documents to request data include a summary of the research plan, request form, and institutional review board (IRB) review. Dataset will be shared after careful examination by the study board of investigators.
Learn more about this trial
Effects of High-flow Oxygen Therapy and Non-invasive Ventilation on Lung Volumes and on Upper Airway
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