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NCT Number: NCT04791488

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital d'Instruction des Armées Sainte-Anne

Toulon, 83800, France

Location status: Recruiting

Location contact

Céline RAMDANI, MD, PhD

CONTACT

[email protected]

483162844 ext. +33

Céline RAMDANI, MD, PhD

PRINCIPAL_INVESTIGATOR

Nicolas VALLEE, PhD

CONTACT

[email protected]

483162849 ext. +33

Sarah RIVES, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Hyperbaric Oxygen Therapy

Procedure

Hyperbaric oxygen therapy protocol

Diving simulation

Procedure

Hyperbaric chamber diving simulation protocol

Primary outcomes

  1. Evolution of decompression sickness clinical symptoms

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

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Céline RAMDANI, MD, PhD

CONTACT

[email protected]

483162844 ext. +33

Nicolas VALLEE, PhD

CONTACT

[email protected]

483162849 ext. +33

Sponsors and collaborators

Lead sponsor

Direction Centrale du Service de Santé des Armées

Other

Registry information

Acronym: OXYDIVE

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Mar 10, 2021
Registry last updated
Apr 28, 2023

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

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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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