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Completed

NCT Number: NCT03980210

Effect of Hyperbaric Oxygen Therapy on Microcirculation

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.

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Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Roger Salengro, CHU

Lille, France

About this study

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 :

  • FiO2 0.21 - 1 ATA
  • FiO2 1 - 1 ATA
  • FiO2 1 - 2.5 ATA
  • FiO2 0.21 - 2.5 ATA
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hyperbaric Oxygen Therapy

Procedure
  • FiO2 0.21 - 1 ATA
  • FiO2 1 - 1 ATA
  • FiO2 1 - 2.5 ATA
  • FiO2 0.21 - 2.5 ATA
  • FiO2 0.21 - 1 ATA

Primary outcomes

  1. Changes in proportion of perfused vessel (PPV)

    Time frame: 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 outcomes

  1. Changes in proportion of perfused vessel (PPV)

    Time frame: 30 minutes after FiO2 1 - 1 ATA exposure

    Proportion of perfused vessel assessed by Sidestream dark field microscopy on the sublingual mucosa

  2. Changes in proportion of perfused vessel (PPV)

    Time frame: 30 minutes after FiO2 0.21 - 2.5 ATA exposure

    Proportion of perfused vessel assessed by Sidestream dark field microscopy on the sublingual mucosa

  3. Changes in hyperemic reaction after a vaso-occlusion test

    Time frame: 30 minutes after FiO2 1 - 2.5 ATA exposure

    Area under curve assessed by near-infrared spectroscopy

  4. Changes in area of hyperaemia after a vaso-occlusion test

    Time frame: 30 minutes after FiO2 1 - 2.5 ATA exposure

    Area under curve assessed by Laser-Doppler

  5. Validation of cardiac output assessed by bioimpedancemetry under hyperbaric condition

    Time frame: 30 minutes after FiO2 1 - 2.5 ATA exposure

    Comparison with transthoracic echocardiography

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

Effect of Hyperbaric Oxygen Therapy on Healthy Volunteers Microcirculation

Acronym: MICROHB

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 10, 2019
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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