NCT04791488

Brief Summary

The impact of oxygen therapy in many pathologies has been subject of recent work, arguing both favourable and harmful effects. Consequently, one can wonder about the influence of hyperoxic gas mixture during diving on the genesis of decompression sickness, but also about the systematic application of normobaric and hyperbaric oxygen in case of proven decompression sickness. In mammals, normoxic concentrations have been redefined at 20-100 mbars at the extracellular level and below 10 mbars in the mitochondria. Under hyperbaric conditions, most of the oxygen being dissolved in blood plasma, a state of hyperoxia is established which escapes the usual delivery and regulation system represented by red blood cells. The results of our team's previous work suggest a specific effect of diving on the levels of circulating mitochondrial DNA (mtDNA), suggesting cellular destruction linked to hyperoxia/hyperbaria. In fact, our studies, carried out on both animals and human divers, have shown that diving accident leads to an increase in mtDNA levels and an immune reaction through the mobilisation of leukocytes. The main objective of this study is to compare the influence of oxygen partial pressure levels on the evolution of clinical and biological variables during hyperbaric oxygen therapy sessions in healthy versus injured divers.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
265

participants targeted

Target at P75+ for not_applicable

Timeline
23mo left

Started Mar 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress68%
Mar 2022Mar 2028

First Submitted

Initial submission to the registry

December 13, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 10, 2021

Completed
1.1 years until next milestone

Study Start

First participant enrolled

March 30, 2022

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2028

Last Updated

April 28, 2023

Status Verified

April 1, 2023

Enrollment Period

6 years

First QC Date

December 13, 2020

Last Update Submit

April 27, 2023

Conditions

Decompression Sickness

Outcome Measures

Primary Outcomes (1)

  • Evolution of decompression sickness clinical symptoms

    Decompression sickness clinical symptoms will be assessed through a medical examination after each hyperbaric session. Decompression sickness clinical symptoms include: paresthesia, sensory deficit, motor deficit, spinal pain, sphincter disorder and brain injury. The evolution of symptoms will be rated as following: total regression, improvement, stabilization, fluctuation or worsening

    Until the end of the oxygen therapy treatment (up to 1 year)

Study Arms (2)

Healthy individuals

EXPERIMENTAL
Procedure: Hyperbaric oxygen therapyProcedure: Diving simulation

Decompression sickness patients

EXPERIMENTAL
Procedure: Hyperbaric oxygen therapy

Interventions

Hyperbaric oxygen therapyPROCEDURE

Hyperbaric oxygen therapy protocol

Decompression sickness patientsHealthy individuals
Diving simulationPROCEDURE

Hyperbaric chamber diving simulation protocol

Healthy individuals

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy subject with no contraindications to diving OR patient admitted to the hospital for suspicion of a diving accident OR patient admitted to the hospital for hyperbaric oxygen therapy

You may not qualify if:

  • Contraindication to diving or contraindication to hyperbaric oxygen therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital d'Instruction des Armées Sainte-Anne

Toulon, 83800, France

RECRUITING

MeSH Terms

Conditions

Decompression Sickness

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

BarotraumaWounds and Injuries

Intervention Hierarchy (Ancestors)

Oxygen Inhalation TherapyRespiratory TherapyTherapeutics

Central Study Contacts

Nicolas VALLEE, PhD

CONTACT

483162849nicolas.vallee@intradef.gouv.fr

Céline RAMDANI, MD, PhD

CONTACT

483162844celine.ramdani@intradef.gouv.fr

Study Design

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

Study Record Dates

First Submitted

December 13, 2020

First Posted

March 10, 2021

Study Start

March 30, 2022

Primary Completion (Estimated)

March 30, 2028

Study Completion (Estimated)

March 30, 2028

Last Updated

April 28, 2023

Record last verified: 2023-04

Locations

FR(1)