Effect of Hyperbaric Oxygen Therapy on Microcirculation
NCT ID: NCT03980210
Last Updated: 2026-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
15 participants
INTERVENTIONAL
2019-06-14
2019-07-25
Brief Summary
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The study will expose fifteen healthy volunteers to a succession of different fraction of inspired oxygen and barometric pressure and assess microcirculatory and macrocirculatory changes via sidestream dark field videomicroscopy, near-infrared spectroscopy, Laser Doppler, transthoracic echocardiography and bio-impedancemetry at every step.
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Detailed Description
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Studies have shown that hyperoxia alters healthy volunteers' microcirculation, whereas hyperbaric oxygen therapy is commonly used to facilitate cicatrization. There seems to be a paradox. A recent study in rabbits has given some evidences that hyperbaria may restore microcirculation integrity, but to date, there is no such evidences in human.
To study hyperoxia and hyperbaric induced changes in micro and macrocirculation, fifteen healthy volunteers will be exposed to successive variations of inspired oxygen fraction and barometric pressure according to a predefine sequence so that only one parameter will change from a condition to the next one :
1. FiO2 0.21 - 1 ATA
2. FiO2 1 - 1 ATA
3. FiO2 1 - 2.5 ATA
4. FiO2 0.21 - 2.5 ATA
5. FiO2 0.21 - 1 ATA
At each time, and after a 30 minutes period of exposure, measures will be made using SDF-microscopy, Laser Doppler and NIRS to assess microcirculation.
As previously described, macrocirculation can modify microcirculation due to a mechanism called hemodynamic coherence.
Hence, the investigators planned to assess macrocirculation changes at every step of the protocol using bioimpedancemetry and transthoracic echocardiography.
Each volunteer will be his own control, using the first measurements (condition 1. FiO2 0.21 - 1 ATA) as reference.
Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Hyperbaric oxygen therapy
Successive changes in fraction of inspired oxygen and barometric pressure (ATA: Atmosphere absolute)
Five successive steps:
1. FiO2 0.21 - 1 ATA
2. FiO2 1 - 1 ATA
3. FiO2 1 - 2.5 ATA
4. FiO2 0.21 - 2.5 ATA
5. FiO2 0.21 - 1 ATA
Hyperbaric oxygen therapy
1. FiO2 0.21 - 1 ATA
2. FiO2 1 - 1 ATA
3. FiO2 1 - 2.5 ATA
4. FiO2 0.21 - 2.5 ATA
5. FiO2 0.21 - 1 ATA
Interventions
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Hyperbaric oxygen therapy
1. FiO2 0.21 - 1 ATA
2. FiO2 1 - 1 ATA
3. FiO2 1 - 2.5 ATA
4. FiO2 0.21 - 2.5 ATA
5. FiO2 0.21 - 1 ATA
Eligibility Criteria
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Inclusion Criteria
* Consent given for study participation
* French health insurance affiliated
Exclusion Criteria
* Pregnancy or \< 18 years of age
* Precedent dive \< 24 hours
* Under a legal protection measure
* Medical history of a disease known to alter microcirculation
18 Years
64 Years
ALL
Yes
Sponsors
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University Hospital, Lille
OTHER
Responsible Party
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Principal Investigators
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Thibault Duburcq, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Lille
Locations
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Hôpital Roger Salengro, CHU
Lille, , France
Countries
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References
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Cousin N, Goutay J, Girardie P, Favory R, Drumez E, Mathieu D, Poissy J, Parmentier E, Duburcq T. Effects of high oxygen tension on healthy volunteer microcirculation. Diving Hyperb Med. 2022 Dec 20;52(4):260-70. doi: 10.28920/dhm52.4.260-270.
Other Identifiers
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2019-A00053-54
Identifier Type: REGISTRY
Identifier Source: secondary_id
2018_63
Identifier Type: -
Identifier Source: org_study_id
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