Reduction of Venous Emboli Load After Breathing Normobaric Oxygen Compared to Air

• Register: ClinicalTrials.gov
• Last refreshed on: 6 June 2022
• Main ID: NCT02468752
• Date of registration: 03/06/2015
• Prospective Registration: No
• Primary sponsor: Göteborg University
• Public title: Reduction of Venous Emboli Load After Breathing Normobaric Oxygen Compared to Air
• Scientific title: Mängden kvävgasbubblor i Blodet Efter Dykning Vid Syrgasandning jämfört Med Luftandning
• Date of first enrolment: May 2015
• Target sample size: 48
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02468752
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Prevention. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 2/Phase 3

Countries of recruitment

Sweden

Contacts

• Name: Mikael Gennser, PhD
• Affiliation: Kungliga Tekniska Högskolan, Stockholm, Sweden

Key inclusion & exclusion criteria

Inclusion Criteria:

- Professional diver

- Fit to dive according to Swedish Navy standards

Exclusion Criteria:

- NONE



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Inflammation

Diving Medicine

Central Nervous Injury

Endothelial Dysfunction

Decompression Sickness

Hyperbaric

Intervention(s)

Other: Air

Drug: Oxygen

Primary Outcome(s)

Venous gas emboli [Time Frame: 120 minutes]

Secondary Outcome(s)

Decompression sickness [Time Frame: 24 hours]

Markers of central nervous system injury [Time Frame: 120 minutes/ 48 hours]

Inflammatory activity and endothelial dysfunction [Time Frame: 120 minutes/ 48 hours]

Secondary ID(s)

DYK 14-16

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

KTH Royal Institute of Technology

Sahlgrenska University Hospital, Sweden

Swedish Armed Forces Diving and Naval Medicine Centre