Impact of Hyperoxia and Involvement of the Immune System in Diving Accident

NCT ID: NCT04791488

Last Updated: 2023-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

265 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-30

Study Completion Date

2028-03-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Decompression Sickness

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Healthy individuals

Group Type EXPERIMENTAL

Hyperbaric oxygen therapy

Intervention Type PROCEDURE

Hyperbaric oxygen therapy protocol

Diving simulation

Intervention Type PROCEDURE

Hyperbaric chamber diving simulation protocol

Decompression sickness patients

Group Type EXPERIMENTAL

Hyperbaric oxygen therapy

Intervention Type PROCEDURE

Hyperbaric oxygen therapy protocol

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Hyperbaric oxygen therapy

Hyperbaric oxygen therapy protocol

Intervention Type PROCEDURE

Diving simulation

Hyperbaric chamber diving simulation protocol

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* Contraindication to diving or contraindication to hyperbaric oxygen therapy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Direction Centrale du Service de Santé des Armées

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hôpital d'Instruction des Armées Sainte-Anne

Toulon, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Nicolas VALLEE, PhD

Role: CONTACT

483162849 ext. +33

Céline RAMDANI, MD, PhD

Role: CONTACT

483162844 ext. +33

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Nicolas VALLEE, PhD

Role: primary

483162849 ext. +33

Céline RAMDANI, MD, PhD

Role: backup

483162844 ext. +33

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2019PBMD05

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Risk Factors for Exertional Heat Illness
NCT04979455 ACTIVE_NOT_RECRUITING
Acute Exercise With Overdressing
NCT07080853 COMPLETED NA
Chronic Exercise With Overdressing
NCT07099872 COMPLETED NA