NCT03980210

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2019

Completed
26 days until next milestone

First Posted

Study publicly available on registry

June 10, 2019

Completed
4 days until next milestone

Study Start

First participant enrolled

June 14, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2019

Completed
Last Updated

January 8, 2026

Status Verified

January 1, 2026

Enrollment Period

1 month

First QC Date

May 15, 2019

Last Update Submit

January 6, 2026

Conditions

Hyperbaric Oxygen Therapy

Keywords

Hyperbaric oxygen therapyNormobaric oxygen therapyHyperoxiaSidestream dark field videomicroscopyMicrocirculation

Outcome Measures

Primary Outcomes (1)

  • Changes in proportion of perfused vessel (PPV)

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

    30 minutes after hyperbaric hyperoxia exposure (FiO2 1 - 2.5 ATA)

Secondary Outcomes (5)

  • Changes in proportion of perfused vessel (PPV)

    30 minutes after FiO2 1 - 1 ATA exposure

  • Changes in proportion of perfused vessel (PPV)

    30 minutes after FiO2 0.21 - 2.5 ATA exposure

  • Changes in hyperemic reaction after a vaso-occlusion test

    30 minutes after FiO2 1 - 2.5 ATA exposure

  • Changes in area of hyperaemia after a vaso-occlusion test

    30 minutes after FiO2 1 - 2.5 ATA exposure

  • Validation of cardiac output assessed by bioimpedancemetry under hyperbaric condition

    30 minutes after FiO2 1 - 2.5 ATA exposure

Study Arms (1)

Hyperbaric oxygen therapy

EXPERIMENTAL

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

Procedure: Hyperbaric oxygen therapy

Interventions

Hyperbaric oxygen therapyPROCEDURE

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

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Roger Salengro, CHU

Lille, France

Location

Related Publications (1)

  • 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.

    PMID: 36525683RESULT

MeSH Terms

Conditions

Hyperoxia

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Oxygen Inhalation TherapyRespiratory TherapyTherapeutics

Study Officials

  • Thibault Duburcq, MD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2019

First Posted

June 10, 2019

Study Start

June 14, 2019

Primary Completion

July 25, 2019

Study Completion

July 25, 2019

Last Updated

January 8, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)