Non Invasive Evaluation of Muscle Hypoxia in COPD Patient (EVANIMUS)

NCT03921983 | Unknown

• 2 other identifiers: RBHP 2018 COSTES2018-A02206-49
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

COPD (Chronic Obstructive Pulmonary Disease); Hypoxemia

Keywords

muscle oxygenation; hypoxia; mitochondrial function; non invasive

Outcome Measures

Primary Outcomes (1)

• mVO2 recovery time constant (k) measured while breathing ambient air

  Time constant (min-1) of NIRS muscle oxygenation kinetics following repetitive arterial occlusions

  day 1

Secondary Outcomes (2)

• variation of k with oxygen supplementation

  day 1

• Mitochondrial affinity for O2

  day 1

Study Arms (2)

LTOT +

EXPERIMENTAL

COPD patients with long term oxygenotherapy

Other: Oxygen supplementation

LTOT -

ACTIVE COMPARATOR

COPD patients without chronic hypoxemia (no LTOT)

Other: Oxygen supplementation

Interventions

Oxygen supplementation OTHER

short term O2 supplementation during 1 hour

LTOT +; LTOT -

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• COPD diagnostic
• Both sex
• \<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).

You may not qualify if:

• 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%)

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Hypoxia

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Frédériv Costes, MD, PhD

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise LACLAUTRE

CONTACT

+334.75754963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: measurements will be made with and without short term oxygen supplementation

Study Record Dates

• First Submitted: April 15, 2019
• First Posted: April 19, 2019
• Study Start: July 1, 2019
• Primary Completion: January 1, 2020
• Study Completion: December 31, 2020
• Last Updated: April 19, 2019

Record last verified: 2019-04

Locations

FR (1)