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

Study acronym: OXYDIVE
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Site contact updatedv7
  2. Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: Jul 2028 to Mar 30, 2028
    • Start date changed from estimate of Jul 2022 to Mar 30, 2022
    • Site details revised
    v6
  3. Primary and study completion dates: Oct 2027 to Jul 2028
    • Start date: Oct 2021 to Jul 2022
    v5
  4. Primary and study completion dates: Jun 2027 to Oct 2027
    • Start date: Sep 2021 to Oct 2021
    v4
  5. Start date: Apr 2021 to Sep 2021
    • Primary and study completion dates: Mar 2027 to Jun 2027
    v3
  6. Start date: Mar 2021 to Apr 2021v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT04791488
Lead Sponsor Direction Centrale du Service de Santé des Armées
Conditions
(from sponsor)		 Decompression Sickness
Related terms Decompression Sickness
Enrollment 265 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov