Impact of Hyperoxia and Involvement of the Immune System in Diving Accident (OXYDIVE)

Direction Centrale du Service de Santé des Armées

Status: Enrolling

Conditions: Decompression Sickness

Treatments: Procedure: Hyperbaric oxygen therapy; Procedure: Diving simulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04791488

2019PBMD05

Details and patient eligibility

About

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.

Enrollment: 265 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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265 participants in 2 patient groups

Healthy individuals

Experimental group

Treatment:

Procedure: Diving simulation

Procedure: Hyperbaric oxygen therapy

Decompression sickness patients

Experimental group

Treatment:

Procedure: Hyperbaric oxygen therapy