Hypoxemic Respiratory FailureNCT04022603
Impact of High-level Oxygen Therapy on the Reconditioning of Type I Hypoxemic Respiratory Insufficiency Patients in Intensive Care
A study testing Cyclometer Ergometer in people with Hypoxemic Respiratory Failure, run by Dr David DE BELS at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoxemic Respiratory Failure
- What is being tested?
- Cyclometer Ergometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- 18 Aug 2017to 3 Aug 2020
- 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
- Acute respiratory insufficiency type I, oxygen partial pressure (PaO2) <60 mmHg under oxygen without hypercapnia.
- Invasive arterial pressure measure
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Hypoxemic Respiratory Failure
- Being tested
- Cyclometer Ergometer
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyclometer ErgometerDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Optiflow nasal googles | Experimental | Oxygen provided by means of high throughput nasal googles (Optiflow, Fisher\&Paykel- New Zealand). Receives: Device: Cyclometer Ergometer |
| Venturi mask | Active comparator | Oxygen provided by means of a Venturi mask. Receives: Device: Cyclometer Ergometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline
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).
Measured: 12 minutes (maximal effort)
Oxygen inspired fraction (FiO2)
Oxygen inspired fraction (FiO2) is the fraction or percentage of oxygen present in the gas mixture that a person breathes.
Measured: Baseline
Oxygen inspired fraction (FiO2)
Oxygen inspired fraction (FiO2) is the fraction or percentage of oxygen present in the gas mixture that a person breathes.
Measured: 12 minutes (maximal effort)
Blood gasometry
Arterial blood analysis
Measured: Baseline
Blood gasometry
Arterial blood analysis
Measured: 12 minutes (maximal effort)
Heart rate
The heart rate is the number of heartbeats per unit minute.
Measured: Baseline
Heart rate
The heart rate is the number of heartbeats per minute.
Measured: 12 minutes (maximal effort)
Respiratory rate
Number of breath cycles (inspiration and expiration) per minute.
Measured: Baseline
Respiratory rate
Number of breath cycles (inspiration and expiration) per minute.
Measured: 12 minutes (maximal effort)
Mean arterial pressure
Mean arterial pressure
Measured: Baseline
Mean arterial pressure
Mean arterial pressure
Measured: 12 minutes (maximal effort)
Systolic blood pressure
Systolic blood pressure (pressure in the artery as the heart contracts)
Measured: Baseline
Systolic blood pressure
Systolic blood pressure (pressure in the artery as the heart contracts)
Measured: 12 minutes (maximal effort)
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).
Measured: 12 minutes (maximal effort)
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.
Measured: Baseline
Functional residual capacity (CFR)
Volume of air remaining in the airways after a spontaneous expiration (not forced)
Measured: Baseline
Secondary outcomes (3)
Age
Age
Measured: Baseline
Weight
Weight
Measured: Baseline
Sex
Sex
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2019
- Study start18 Aug 2017
- Primary completion3 Aug 2020
- Study completion3 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoxemic Respiratory FailureStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr David DE BELS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr David DE BELS, Brugmann University Hospital
- Investigators
- Sébastien Redant, Principal investigator, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04022603
- Sponsor's protocol ID
- CHUB-BPCO
- Status last verified
- Mar 2022
- First submitted
- 15 Jul 2019
- Last updated
- 4 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of High-level Oxygen Therapy on the Reconditioning of Type I Hypoxemic Respiratory Insufficiency Patients in Intensive Care
- ClinicalTrials.gov ID
- NCT04022603
- Acronym / sponsor ID
- CHUB-BPCO
- Conditions
- Hypoxemic Respiratory Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Dr David DE BELSUniversity, hospital or other
- Study start
- 18 Aug 2017 (actual)
- Primary completion
- 3 Aug 2020 (actual)
- Study completion
- 3 Aug 2020 (actual)
- First posted
- 17 Jul 2019 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Optiflow nasal googles | Experimental | Device: Cyclometer ErgometerOxygen provided by means of high throughput nasal googles (Optiflow, Fisher\&Paykel- New Zealand). |
| Venturi mask | Active comparator | Device: Cyclometer ErgometerOxygen provided by means of a Venturi mask. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Acute respiratory insufficiency type I, oxygen partial pressure (PaO2) <60 mmHg under oxygen without hypercapnia.
- Invasive arterial pressure measure
Key exclusion criteria (7 listed)
- Hemodynamic instability
- Patient under continuous high throughput oxygen therapy
- Left cardiac insufficiency
- Arteritis of the lower limbs
- Neuromuscular pathology
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 |
|---|---|---|
| Cyclometer ErgometerThe 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. | Device | Optiflow nasal googles, Venturi mask |
Primary outcome
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)
3 secondary outcomes
Age
Time frame: Baseline
Weight
Time frame: Baseline
Sex
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2022.
- Individual participant dataSharing planned: No
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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.
Sébastien Redant principal investigator
CHU Brugmann
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cyclometer Ergometer in people with Hypoxemic Respiratory Failure, run by Dr David DE BELS at 1 site in Belgium.
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 7 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: finished, as of the sponsor's last update on 4 Mar 2022. 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 Belgium. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pulsated oxygen saturation (Sp02) (time frame: Baseline). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Mar 2022.