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

Primary Purpose

Decompression Sickness

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Hyperbaric oxygen therapy
Diving simulation
Sponsored by
Direction Centrale du Service de Santé des Armées
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Decompression Sickness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Hôpital d'Instruction des Armées Sainte-AnneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Healthy individuals

Decompression sickness patients

Arm Description

Outcomes

Primary Outcome Measures

Evolution of decompression sickness clinical symptoms
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

Secondary Outcome Measures

Full Information

First Posted
December 13, 2020
Last Updated
April 27, 2023
Sponsor
Direction Centrale du Service de Santé des Armées
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1. Study Identification

Unique Protocol Identification Number
NCT04791488
Brief Title
Impact of Hyperoxia and Involvement of the Immune System in Diving Accident
Acronym
OXYDIVE
Official Title
Impact of Hyperoxia and Involvement of the Immune System in Diving Accident
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 30, 2022 (Actual)
Primary Completion Date
March 30, 2028 (Anticipated)
Study Completion Date
March 30, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Direction Centrale du Service de Santé des Armées

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Decompression Sickness

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
265 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy individuals
Arm Type
Experimental
Arm Title
Decompression sickness patients
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Hyperbaric oxygen therapy
Intervention Description
Hyperbaric oxygen therapy protocol
Intervention Type
Procedure
Intervention Name(s)
Diving simulation
Intervention Description
Hyperbaric chamber diving simulation protocol
Primary Outcome Measure Information:
Title
Evolution of decompression sickness clinical symptoms
Description
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
Time Frame
Until the end of the oxygen therapy treatment (up to 1 year)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicolas VALLEE, PhD
Phone
483162849
Ext
+33
Email
nicolas.vallee@intradef.gouv.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Céline RAMDANI, MD, PhD
Phone
483162844
Ext
+33
Email
celine.ramdani@intradef.gouv.fr
Facility Information:
Facility Name
Hôpital d'Instruction des Armées Sainte-Anne
City
Toulon
ZIP/Postal Code
83800
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas VALLEE, PhD
Phone
483162849
Ext
+33
Email
nicolas.vallee@intradef.gouv.fr
First Name & Middle Initial & Last Name & Degree
Céline RAMDANI, MD, PhD
Phone
483162844
Ext
+33
Email
celine.ramdani@intradef.gouv.fr
First Name & Middle Initial & Last Name & Degree
Céline RAMDANI, MD, PhD
First Name & Middle Initial & Last Name & Degree
Sarah RIVES, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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