Clinical Trial

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

Study acronym: OXYDIVE
Recruiting
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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.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2021-03-08; most recent amendment 2023-04-27.
Status change: Not Yet Recruiting → Recruiting 2022-04-14
Trial Details
NCT Number NCT04791488
Lead Sponsor Direction Centrale du Service de Santé des Armées
Conditions Decompression Sickness
Enrollment 265 participants
Start Date 2022-03-30
Primary Completion 2028-03-30 (estimated)
Study Completion 2028-03-30 (estimated)
Updated on ClinicalTrials.gov 2023-04-28