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Effect of Hyperbaric Oxygen Therapy on Microcirculation

Effect of Hyperbaric Oxygen Therapy on Healthy Volunteers Microcirculation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03980210
Acronym
MICROHB
Enrollment
15
Registered
2019-06-10
Start date
2019-06-14
Completion date
2019-07-25
Last updated
2026-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperbaric Oxygen Therapy

Keywords

Hyperbaric oxygen therapy, Normobaric oxygen therapy, Hyperoxia, Sidestream dark field videomicroscopy, Microcirculation

Brief summary

Previous studies shoes that hyperoxia alters microcirculation.The investigators hypothesize that hyperbaric may restore microcirculation integrity. This hypothesis is supported by a recent study in rabbits, but no data exists for humans. 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.

Detailed description

Microcirculation alterations and hyperoxia are known to alter ICU-patients' prognostic. 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.

Interventions

PROCEDUREHyperbaric 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

Sponsors

University Hospital, Lille
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes

Inclusion criteria

* To provide a medical certificate of fitness to dive (\< 1 year) * Consent given for study participation * French health insurance affiliated

Exclusion criteria

* Temporary or definitive contra-indication to dive * Pregnancy or \< 18 years of age * Precedent dive \< 24 hours * Under a legal protection measure * Medical history of a disease known to alter microcirculation

Design outcomes

Primary

MeasureTime frameDescription
Changes in proportion of perfused vessel (PPV)30 minutes after hyperbaric hyperoxia exposure (FiO2 1 - 2.5 ATA)Proportion of perfused vessel assessed by Sidestream dark field microscopy on the sublingual mucosa

Secondary

MeasureTime frameDescription
Changes in proportion of perfused vessel (PPV)30 minutes after FiO2 1 - 1 ATA exposureProportion of perfused vessel assessed by Sidestream dark field microscopy on the sublingual mucosa
Changes in hyperemic reaction after a vaso-occlusion test30 minutes after FiO2 1 - 2.5 ATA exposureArea under curve assessed by near-infrared spectroscopy
Changes in area of hyperaemia after a vaso-occlusion test30 minutes after FiO2 1 - 2.5 ATA exposureArea under curve assessed by Laser-Doppler
Validation of cardiac output assessed by bioimpedancemetry under hyperbaric condition30 minutes after FiO2 1 - 2.5 ATA exposureComparison with transthoracic echocardiography

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026