COPD (Chronic Obstructive Pulmonary Disease)EVANIMUSNCT03921983
Non Invasive Evaluation of Muscle Hypoxia in COPD Patient (EVANIMUS)
A study testing Oxygen supplementation in people with COPD (Chronic Obstructive Pulmonary Disease) and Hypoxemia, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Peripheral muscle oxidative function is altered in COPD(chronic obstrutive pulmonary disease) patients. Multiple factors could contribute to this dysfunction including chronic hypoxia and deconditioning (sedentarity). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease), Hypoxemia
- What is being tested?
- Oxygen supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2019to 31 Dec 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD diagnostic
- Both sex
- 18 <Age <80 years old
- LTOT- group : PaO2 ≥ 65 mmHg and SaO2≥ 92%
- LTOT+ group: long term oxygenotherapy prescribed for more than 3 months, with daily use between 12 and 15 hours.
- Patients in both groups will be matched for age (± 5 years), sex and physical activity estimated by GPAQ questionnaire (± 15% Mets.min/week).
Who cannot join
- Recent cardiorespiratory exacerbation (<6 weeks).
- Pulmonary rehabilitation program during the last 2 months
- Continuous LTOT (24 hours) or deambulation O2 therapy alone
- Anticoagulant drugs
- Hematocrit outside the normal range (35-50%)
Trial locations and contacts
1 site in 1 country.
France1 site
CHU de Clermont-Ferrand
Clermont-Ferrand, 63000
Lise LACLAUTRE, +33473754963, promo_interne_drci@chu-clermontferrand.fr
Frédéric Costes, MD, PhD
About this study
Official title: Non Invasive Evaluation of Muscle Hypoxia in Chronic Obstructive Pulmonary Disease Patient
Peripheral muscle oxidative function is altered in COPD(chronic obstrutive pulmonary disease) patients. Multiple factors could contribute to this dysfunction including chronic hypoxia and deconditioning (sedentarity).
The evaluation of mitochondrial function is based on invasive method (muscle biopsy and in vitro respirometry) or magnetic resonance spectroscopy limited to small muscle groups. Recently, a non invasive method has been described using Near InfraRed Spectroscopy (NIRS). During arterial occlusion, muscle deoxygenation is only dependent of local oxygen consumption. The time constant recovery (k) of the deoxygenation during repeated ischemia periods has been shown to be correlated to measurements of maximal mitochondrial capacity.
Read more
k is lower in COPD patients compared to smokers without bronchial obstruction. However, the influence of arterial hypoxia has never been studied precisely, no more than the confounding effect of deconditioning on k.
So , the aim is to compare k in COPD patients with chronic hypoxemia (treated with long term oxygenotherapy, LTOT+ group) and patients without hypoxia, matched for their physical activity (LTOT- group).
The hypothe is that k will be lower in LTOT+ group compared to LTOT- group and that short term O2 supplementation will improve it, which would suggest a muscle hypoxia. By contrast, O2 should not influence k in LOT- group, in whom it is mainly determined by muscle conditioning.
Read the detailed description
Investigator will compare mVO2 time constant in 2 groups of COPD (chronic obstrutive pulmonary disease) patients matched for age, sex, physical activity (estimated by GPAQ questionnaire (Global Physical Activity Questionnaire)), one with chronic hypoxemia (LTOT+ group) and one without blood gas abnormalities (LTOT- group)..
Inclusion visit It will allow to calculate physical activity in Mets.min/week, from the GPAQ questionnaire. The patient will also be accustomed to the repeated arterial occlusion procedure. A pneumatic cuff will be wrapped around the thigh and will be progressively inflated to a suprasystolic value (rapid air inflation system Hokanson), from 160 mmHg up to tolerated maximal pressure (max 220 mmHg).
Experimental visit
- Muscle biopsy. A biopsy of the vastus lateralis will be performed while breathing ambient air. After disinfection and anesthesia of skin and subcutaneous tissue, an automatic biopsy gun (Monopty Bard 14G) will be introduced in the muscle and a 20 mg biopsy will be withdrawn. The maximal mitochondrial O2 consumption and mitochondrial affinity for O2 will be immediately measured with high resolution respirometry (Oroboros, 10 mg tissue). A 10 mg fragment will be stored in liquid nitrogen for mRNA analysis of hypoxia driven genes (Hypoxia-inducible Factor 1, Vascular Endothelial Growth Factor, Carbonic Anhydrase 9, Heme Oxygenase 1).
- mVO2 time constant measurement (k, min-1) in ambient air. A NIRS probe (Oxymon III) will be placed on the thigh (contralateral to the muscle biopsy) and secured with an elastic wrap. The NIRS signal will be displayed continuously and recorded on a software (Oxysoft) The inflation cuff will be placed upstream the NIRS probe. After 5 to 10 isometric contractions of the quadriceps, the cuff will be rapidly inflated (maximal tolerated pressure determined during the inclusion visit) and deflated according to a predetermined protocol: 5 s /5 s 5 times, followed by 7 s /7 s 5 times and then 10 s/10 s 10 times. The deoxygenation kinetics (% deoxygenation/min) will be calculated for every occlusion and these deoxygenation indices will be expressed over time in order to calculate the time constant of the exponential relationship (k, min-1). This sequence will be repeated twice and the k values will be averaged.
- mVO2 time constant measurement with O2. Oxygen therapy will be given to the patient for 1 hour before repeating the k determination as described above. Oxygen flow will be set to the habitual flow rate in the LTOT+ group, and an arbitrary 3 L/min flow rate in the LTOT- group.
- Being tested
- Oxygen supplementation
- Keywords
- muscle oxygenation, hypoxia, mitochondrial function, non invasive
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxygen supplementationOther
short term O2 supplementation during 1 hour
| Study group | Role | What they receive |
|---|---|---|
| LTOT + | Experimental | COPD patients with long term oxygenotherapy Receives: Other: Oxygen supplementation |
| LTOT - | Active comparator | COPD patients without chronic hypoxemia (no LTOT) Receives: Other: Oxygen supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
mVO2 recovery time constant (k) measured while breathing ambient air
Time constant (min-1) of NIRS muscle oxygenation kinetics following repetitive arterial occlusions
Measured: day 1
Secondary outcomes (2)
variation of k with oxygen supplementation
Difference of the time constant (k, min-1) between 2 conditions: ambient air and with oxygen supplementation
Measured: day 1
Mitochondrial affinity for O2
Apparent K (µmol O2/min/g tissue) measured with respirometry on permeabilized muscle fibers at decreasing concentration of O2
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2019
- Study start1 Jul 2019 (estimated)
- Primary completion1 Jan 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD (Chronic Obstructive Pulmonary Disease)Studies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- measurements will be made with and without short term oxygen supplementation
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frédériv Costes, MD, PhD, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03921983
- Sponsor's protocol ID
- RBHP 2018 COSTES
- Other IDs
- 2018-A02206-49
- Acronym
- EVANIMUS
- Status last verified
- Apr 2019
- First submitted
- 15 Apr 2019
- Last updated
- 19 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non Invasive Evaluation of Muscle Hypoxia in Chronic Obstructive Pulmonary Disease Patient
- ClinicalTrials.gov ID
- NCT03921983
- Acronym / sponsor ID
- EVANIMUS / RBHP 2018 COSTES
- Keywords
- muscle oxygenation, hypoxia, mitochondrial function, non invasive
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 1 Jul 2019 (estimated)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 19 Apr 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.
Peripheral muscle oxidative function is altered in COPD(chronic obstrutive pulmonary disease) patients. Multiple factors could contribute to this dysfunction including chronic hypoxia and deconditioning (sedentarity).
The evaluation of mitochondrial function is based on invasive method (muscle biopsy and in vitro respirometry) or magnetic resonance spectroscopy limited to small muscle groups. Recently, a non invasive method has been described using Near InfraRed Spectroscopy (NIRS). During arterial occlusion, muscle deoxygenation is only dependent of local oxygen consumption. The time constant recovery (k) of the deoxygenation during repeated ischemia periods has been shown to be correlated to measurements of maximal mitochondrial capacity.
k is lower in COPD patients compared to smokers without bronchial obstruction. However, the influence of arterial hypoxia has never been studied precisely, no more than the confounding effect of deconditioning on k.
So , the aim is to compare k in COPD patients with chronic hypoxemia (treated with long term oxygenotherapy, LTOT+ group) and patients without hypoxia, matched for their physical activity (LTOT- group).
The hypothe is that k will be lower in LTOT+ group compared to LTOT- group and that short term O2 supplementation will improve it, which would suggest a muscle hypoxia. By contrast, O2 should not influence k in LOT- group, in whom it is mainly determined by muscle conditioning.
Detailed description
Investigator will compare mVO2 time constant in 2 groups of COPD (chronic obstrutive pulmonary disease) patients matched for age, sex, physical activity (estimated by GPAQ questionnaire (Global Physical Activity Questionnaire)), one with chronic hypoxemia (LTOT+ group) and one without blood gas abnormalities (LTOT- group)..
Inclusion visit It will allow to calculate physical activity in Mets.min/week, from the GPAQ questionnaire. The patient will also be accustomed to the repeated arterial occlusion procedure. A pneumatic cuff will be wrapped around the thigh and will be progressively inflated to a suprasystolic value (rapid air inflation system Hokanson), from 160 mmHg up to tolerated maximal pressure (max 220 mmHg).
Experimental visit
- Muscle biopsy. A biopsy of the vastus lateralis will be performed while breathing ambient air. After disinfection and anesthesia of skin and subcutaneous tissue, an automatic biopsy gun (Monopty Bard 14G) will be introduced in the muscle and a 20 mg biopsy will be withdrawn. The maximal mitochondrial O2 consumption and mitochondrial affinity for O2 will be immediately measured with high resolution respirometry (Oroboros, 10 mg tissue). A 10 mg fragment will be stored in liquid nitrogen for mRNA analysis of hypoxia driven genes (Hypoxia-inducible Factor 1, Vascular Endothelial Growth Factor, Carbonic Anhydrase 9, Heme Oxygenase 1).
- mVO2 time constant measurement (k, min-1) in ambient air. A NIRS probe (Oxymon III) will be placed on the thigh (contralateral to the muscle biopsy) and secured with an elastic wrap. The NIRS signal will be displayed continuously and recorded on a software (Oxysoft) The inflation cuff will be placed upstream the NIRS probe. After 5 to 10 isometric contractions of the quadriceps, the cuff will be rapidly inflated (maximal tolerated pressure determined during the inclusion visit) and deflated according to a predetermined protocol: 5 s /5 s 5 times, followed by 7 s /7 s 5 times and then 10 s/10 s 10 times. The deoxygenation kinetics (% deoxygenation/min) will be calculated for every occlusion and these deoxygenation indices will be expressed over time in order to calculate the time constant of the exponential relationship (k, min-1). This sequence will be repeated twice and the k values will be averaged.
- mVO2 time constant measurement with O2. Oxygen therapy will be given to the patient for 1 hour before repeating the k determination as described above. Oxygen flow will be set to the habitual flow rate in the LTOT+ group, and an arbitrary 3 L/min flow rate in the LTOT- group.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- measurements will be made with and without short term oxygen supplementation
| Arm | Type | Receives |
|---|---|---|
| LTOT + | Experimental | Other: Oxygen supplementationCOPD patients with long term oxygenotherapy |
| LTOT - | Active comparator | Other: Oxygen supplementationCOPD patients without chronic hypoxemia (no LTOT) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- COPD diagnostic
- Both sex
- 18 <Age <80 years old
- LTOT- group : PaO2 ≥ 65 mmHg and SaO2≥ 92%
- LTOT+ group: long term oxygenotherapy prescribed for more than 3 months, with daily use between 12 and 15 hours.
Key exclusion criteria (5 listed)
- Recent cardiorespiratory exacerbation (<6 weeks).
- Pulmonary rehabilitation program during the last 2 months
- Continuous LTOT (24 hours) or deambulation O2 therapy alone
- Anticoagulant drugs
- Hematocrit outside the normal range (35-50%)
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 |
|---|---|---|
| Oxygen supplementationshort term O2 supplementation during 1 hour | Other | LTOT +, LTOT - |
Primary outcome
mVO2 recovery time constant (k) measured while breathing ambient air
Time frame: day 1
Time constant (min-1) of NIRS muscle oxygenation kinetics following repetitive arterial occlusions
2 secondary outcomes
variation of k with oxygen supplementation
Time frame: day 1
Mitochondrial affinity for O2
Time frame: day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2019.
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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.
Frédériv Costes, MD, PhD principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxygen supplementation in people with COPD (Chronic Obstructive Pulmonary Disease) and Hypoxemia, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 19 Apr 2019. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lise LACLAUTRE (+334.75754963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mVO2 recovery time constant (k) measured while breathing ambient air (time frame: day 1). 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 19 Apr 2019.