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出境医 / 临床实验 / Impact of High-level Oxygen Therapy on the Reconditioning of Type I Hypoxemic Respiratory Insufficiency Patients in Intensive Care
Impact of High-level Oxygen Therapy on the Reconditioning of Type I Hypoxemic Respiratory Insufficiency Patients in Intensive Care
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hypoxemic Respiratory Failure | Device: Cyclometer Ergometer | Not Applicable |
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 30 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Impact of High-level Oxygen Therapy on the Reconditioning of Type I Hypoxemic Respiratory Insufficiency Patients in Intensive Care |
| Actual Study Start Date : | August 18, 2017 |
| Estimated Primary Completion Date : | December 31, 2019 |
| Estimated Study Completion Date : | December 31, 2019 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Optiflow nasal googles
Oxygen provided by means of high throughput nasal googles (Optiflow, Fisher&Paykel- New Zealand).
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Device: Cyclometer Ergometer
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.
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Active Comparator: Venturi mask
Oxygen provided by means of a Venturi mask.
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Device: Cyclometer Ergometer
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.
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Outcome Measures
Primary Outcome Measures :
- Pulsated oxygen saturation (Sp02) [ Time Frame: Baseline ]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) [ Time Frame: 12 minutes (maximal effort) ]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) [ Time Frame: Baseline ]Oxygen inspired fraction (FiO2) is the fraction or percentage of oxygen present in the gas mixture that a person breathes.
- Oxygen inspired fraction (FiO2) [ Time Frame: 12 minutes (maximal effort) ]Oxygen inspired fraction (FiO2) is the fraction or percentage of oxygen present in the gas mixture that a person breathes.
- Blood gasometry [ Time Frame: Baseline ]Arterial blood analysis
- Blood gasometry [ Time Frame: 12 minutes (maximal effort) ]Arterial blood analysis
- Heart rate [ Time Frame: Baseline ]The heart rate is the number of heartbeats per unit minute.
- Heart rate [ Time Frame: 12 minutes (maximal effort) ]The heart rate is the number of heartbeats per minute.
- Respiratory rate [ Time Frame: Baseline ]Number of breath cycles (inspiration and expiration) per minute.
- Respiratory rate [ Time Frame: 12 minutes (maximal effort) ]Number of breath cycles (inspiration and expiration) per minute.
- Mean arterial pressure [ Time Frame: Baseline ]Mean arterial pressure
- Mean arterial pressure [ Time Frame: 12 minutes (maximal effort) ]Mean arterial pressure
- Systolic blood pressure [ Time Frame: Baseline ]Systolic blood pressure (pressure in the artery as the heart contracts)
- Systolic blood pressure [ Time Frame: 12 minutes (maximal effort) ]Systolic blood pressure (pressure in the artery as the heart contracts)
- Borg score [ Time Frame: 12 minutes (maximal effort) ]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) [ Time Frame: Baseline ]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) [ Time Frame: Baseline ]Volume of air remaining in the airways after a spontaneous expiration (not forced)
Secondary Outcome Measures :
- Age [ Time Frame: Baseline ]Age
- Weight [ Time Frame: Baseline ]Weight
- Sex [ Time Frame: Baseline ]Sex
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Contacts
| Contact: Sébastien Redant, MD | 3224773100 | Sebastien.REDANT@chu-brugmann.be |
Locations
| Belgium | |
| CHU Brugmann | Recruiting |
| Brussels, Belgium, 1020 | |
| Contact: David De Bels, MD 3224779127 David.DEBELS@chu-brugmann.be | |
Sponsors and Collaborators
Dr David DE BELS
Investigators
| Principal Investigator: | Sébastien Redant | CHU Brugmann |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | July 15, 2019 | ||||
| First Posted Date ICMJE | July 17, 2019 | ||||
| Last Update Posted Date | July 17, 2019 | ||||
| Actual Study Start Date ICMJE | August 18, 2017 | ||||
| Estimated Primary Completion Date | December 31, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Impact of High-level Oxygen Therapy on the Reconditioning of Type I Hypoxemic Respiratory Insufficiency Patients in Intensive Care | ||||
| Official Title ICMJE | Impact of High-level Oxygen Therapy on the Reconditioning of Type I Hypoxemic Respiratory Insufficiency Patients in Intensive Care | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE | Hypoxemic Respiratory Failure | ||||
| Intervention ICMJE | Device: Cyclometer Ergometer
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.
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE |
30 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | December 31, 2019 | ||||
| Estimated Primary Completion Date | December 31, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Belgium | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT04022603 | ||||
| Other Study ID Numbers ICMJE | CHUB-BPCO | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Dr David DE BELS, Brugmann University Hospital | ||||
| Study Sponsor ICMJE | Dr David DE BELS | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | Brugmann University Hospital | ||||
| Verification Date | July 2019 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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