Impact of High-level Oxygen Therapy on the Reconditioning of Type I Hypoxemic Respiratory Insufficiency Patients in Intensive Care
Primary Purpose
Hypoxemic Respiratory Failure
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Cyclometer Ergometer
Sponsored by
About this trial
This is an interventional treatment trial for Hypoxemic Respiratory Failure
Eligibility Criteria
Inclusion Criteria:
- Acute respiratory insufficiency type I, oxygen partial pressure (PaO2) <60 mmHg under oxygen without hypercapnia.
- Invasive arterial pressure measure
Exclusion Criteria:
- Hemodynamic instability
- Patient under continuous high throughput oxygen therapy
- Left cardiac insufficiency
- Arteritis of the lower limbs
- Neuromuscular pathology
- Osteo-articular limitations
- Hemoglobin inferior to 8g/dl
Sites / Locations
- CHU Brugmann
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Optiflow nasal googles
Venturi mask
Arm Description
Oxygen provided by means of high throughput nasal googles (Optiflow, Fisher&Paykel- New Zealand).
Oxygen provided by means of a Venturi mask.
Outcomes
Primary Outcome Measures
Pulsated oxygen saturation (Sp02)
SpO2 is an estimate of the amount of oxygen in the blood. More precisely, it represents the percentage of oxygenated hemoglobin (containing oxygen) relative to the total amount of hemoglobin in the blood (oxygenated hemoglobin and non-oxygenated hemoglobin).
Pulsated oxygen saturation (Sp02)
SpO2 is an estimate of the amount of oxygen in the blood. More precisely, it represents the percentage of oxygenated hemoglobin (containing oxygen) relative to the total amount of hemoglobin in the blood (oxygenated hemoglobin and non-oxygenated hemoglobin).
Oxygen inspired fraction (FiO2)
Oxygen inspired fraction (FiO2) is the fraction or percentage of oxygen present in the gas mixture that a person breathes.
Oxygen inspired fraction (FiO2)
Oxygen inspired fraction (FiO2) is the fraction or percentage of oxygen present in the gas mixture that a person breathes.
Blood gasometry
Arterial blood analysis
Blood gasometry
Arterial blood analysis
Heart rate
The heart rate is the number of heartbeats per unit minute.
Heart rate
The heart rate is the number of heartbeats per minute.
Respiratory rate
Number of breath cycles (inspiration and expiration) per minute.
Respiratory rate
Number of breath cycles (inspiration and expiration) per minute.
Mean arterial pressure
Mean arterial pressure
Mean arterial pressure
Mean arterial pressure
Systolic blood pressure
Systolic blood pressure (pressure in the artery as the heart contracts)
Systolic blood pressure
Systolic blood pressure (pressure in the artery as the heart contracts)
Borg score
The Borg scale is a quantitative measure of the perception of effort during exercise. The scale between 0 and 10 was designed to approximate the heart rate of a healthy young adult (effort 8 represents 80% of the cardiac frequency).
Forced expiratory volume per second (FEV1)
The "Forced Expiratory Volume Per Second" (FEV1) is the volume of air exhaled during the first second of a so-called "forced" exhalation, following deep inspiration. It is measured by spirometry.
Functional residual capacity (CFR)
Volume of air remaining in the airways after a spontaneous expiration (not forced)
Secondary Outcome Measures
Age
Age
Weight
Weight
Sex
Sex
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04022603
Brief Title
Impact of High-level Oxygen Therapy on the Reconditioning of Type I Hypoxemic Respiratory Insufficiency Patients in Intensive Care
Official Title
Impact of High-level Oxygen Therapy on the Reconditioning of Type I Hypoxemic Respiratory Insufficiency Patients in Intensive Care
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
August 18, 2017 (Actual)
Primary Completion Date
August 3, 2020 (Actual)
Study Completion Date
August 3, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr David DE BELS
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
High-throughput oxygen therapy is known as an alternative to non-invasive ventilation, with a benefit in terms of survival in non-hypercapnic respiratory failure patients.
The use of high-throughput oxygen therapy is well studied in stable chronic obstructive pulmonary disease (COPD) patients and has as known effects the decrease of transcutaneous CO2 and respiratory rate, and the increase in the inspiratory/expiratory time report, in the tidal volume and in the forced expiratory volume per second.
In the event of an exacerbation, high-flow oxygen therapy has shown to be beneficial in terms of increased mean airway pressure, tidal volume with a decrease in hypercapnia, and respiratory rate.
The net effect on the CO2 pressure is linked to the CO2 clearance of the dead anatomical space by the high throughput. The effect can be compared with the one of non invasive ventilation in a stable COPD patient.
Oxygen therapy, even in patients with non-hypoxic COPD at rest, has benefits in terms of performance and improvement of quality of life. High-throughput oxygen therapy has also shown a benefit in COPD patients in revalidation units, in terms of exercise performance and oxygenation.
However, the reconditioning of critical patients in acute situations, by means of nasal goggles, has never been studied.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxemic Respiratory Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Optiflow nasal googles
Arm Type
Experimental
Arm Description
Oxygen provided by means of high throughput nasal googles (Optiflow, Fisher&Paykel- New Zealand).
Arm Title
Venturi mask
Arm Type
Active Comparator
Arm Description
Oxygen provided by means of a Venturi mask.
Intervention Type
Device
Intervention Name(s)
Cyclometer Ergometer
Intervention Description
The measurements are carried out on a max effort of 12 minutes on a cyclometer ergometer with a constant load (Motomed viva2 light). A first effort is made with a Venturi type mask whose Inspired Fraction in Oxygen (FiO2) is set for a pulsated oxygen saturation (SpO2) greater than or equal to 85%, and then a second at 2h interval with high-throughput googles (Optiflow) with the corresponding FiO2.
Primary Outcome Measure Information:
Title
Pulsated oxygen saturation (Sp02)
Description
SpO2 is an estimate of the amount of oxygen in the blood. More precisely, it represents the percentage of oxygenated hemoglobin (containing oxygen) relative to the total amount of hemoglobin in the blood (oxygenated hemoglobin and non-oxygenated hemoglobin).
Time Frame
Baseline
Title
Pulsated oxygen saturation (Sp02)
Description
SpO2 is an estimate of the amount of oxygen in the blood. More precisely, it represents the percentage of oxygenated hemoglobin (containing oxygen) relative to the total amount of hemoglobin in the blood (oxygenated hemoglobin and non-oxygenated hemoglobin).
Time Frame
12 minutes (maximal effort)
Title
Oxygen inspired fraction (FiO2)
Description
Oxygen inspired fraction (FiO2) is the fraction or percentage of oxygen present in the gas mixture that a person breathes.
Time Frame
Baseline
Title
Oxygen inspired fraction (FiO2)
Description
Oxygen inspired fraction (FiO2) is the fraction or percentage of oxygen present in the gas mixture that a person breathes.
Time Frame
12 minutes (maximal effort)
Title
Blood gasometry
Description
Arterial blood analysis
Time Frame
Baseline
Title
Blood gasometry
Description
Arterial blood analysis
Time Frame
12 minutes (maximal effort)
Title
Heart rate
Description
The heart rate is the number of heartbeats per unit minute.
Time Frame
Baseline
Title
Heart rate
Description
The heart rate is the number of heartbeats per minute.
Time Frame
12 minutes (maximal effort)
Title
Respiratory rate
Description
Number of breath cycles (inspiration and expiration) per minute.
Time Frame
Baseline
Title
Respiratory rate
Description
Number of breath cycles (inspiration and expiration) per minute.
Time Frame
12 minutes (maximal effort)
Title
Mean arterial pressure
Description
Mean arterial pressure
Time Frame
Baseline
Title
Mean arterial pressure
Description
Mean arterial pressure
Time Frame
12 minutes (maximal effort)
Title
Systolic blood pressure
Description
Systolic blood pressure (pressure in the artery as the heart contracts)
Time Frame
Baseline
Title
Systolic blood pressure
Description
Systolic blood pressure (pressure in the artery as the heart contracts)
Time Frame
12 minutes (maximal effort)
Title
Borg score
Description
The Borg scale is a quantitative measure of the perception of effort during exercise. The scale between 0 and 10 was designed to approximate the heart rate of a healthy young adult (effort 8 represents 80% of the cardiac frequency).
Time Frame
12 minutes (maximal effort)
Title
Forced expiratory volume per second (FEV1)
Description
The "Forced Expiratory Volume Per Second" (FEV1) is the volume of air exhaled during the first second of a so-called "forced" exhalation, following deep inspiration. It is measured by spirometry.
Time Frame
Baseline
Title
Functional residual capacity (CFR)
Description
Volume of air remaining in the airways after a spontaneous expiration (not forced)
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Age
Description
Age
Time Frame
Baseline
Title
Weight
Description
Weight
Time Frame
Baseline
Title
Sex
Description
Sex
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Acute respiratory insufficiency type I, oxygen partial pressure (PaO2) <60 mmHg under oxygen without hypercapnia.
Invasive arterial pressure measure
Exclusion Criteria:
Hemodynamic instability
Patient under continuous high throughput oxygen therapy
Left cardiac insufficiency
Arteritis of the lower limbs
Neuromuscular pathology
Osteo-articular limitations
Hemoglobin inferior to 8g/dl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sébastien Redant
Organizational Affiliation
CHU Brugmann
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Brugmann
City
Brussels
ZIP/Postal Code
1020
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Impact of High-level Oxygen Therapy on the Reconditioning of Type I Hypoxemic Respiratory Insufficiency Patients in Intensive Care
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