Mängden kvävgasbubblor i Blodet Efter Dykning Vid Syrgasandning jämfört Med Luftandning
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 48
- Locations
- 2
- Primary Endpoint
- Venous gas emboli
Study Overview
Brief Summary
Primary objective:
- Assessment of venous gas emboli load post diving when breathing normobaric oxygen compared to air.
Secondary objective:
- Assessment of fluid markers of central nervous system injury in blood post diving
- Assessment of fluid markers of inflammation and endothelial dysfunction in blood post diving
Tertiary objective:
- Assessment of DCS frequency
Detailed Description
This is a prospective, double blinded, randomized, cross-over study in Sweden. The study was performed in two different sets, each containing standardized dives in a wet hyperbaric chamber. The dives included movement on depth.
In each study set 16-32 professional divers performed no-decompression dives to a depth of 42 metres of seawater (msw). The gas used during the dives was compressed air.
After surfacing the divers breathed either normobaric oxygen or normobaric air on a demand mask. Timing of oxygen/air-breathing differed between study sets. The content of breathing gas was unknown to both divers and examining personnel.
Immediately post dive the divers were assessed using either transthoracic doppler ultrasound (TTD) or transthoracic 2-D ultrasound (TTE) to determine VGE load, time to VGE detection and VGE duration.
Signs of DCS were actively sought.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Professional diver
- •Fit to dive according to Swedish Navy standards
Exclusion Criteria
- Not provided
Arms & Interventions
Air
Normobaric air breathing
Intervention: Air (Other)
Oxygen
Normobaric oxygen breathing
Intervention: Oxygen (Drug)
Outcomes
Primary Outcomes
Venous gas emboli
Time Frame: 120 minutes
Kisman-Masurel grading
Secondary Outcomes
- Inflammatory activity and endothelial dysfunction(120 minutes/ 48 hours)
- Decompression sickness(24 hours)
- Markers of central nervous system injury(120 minutes/ 48 hours)
Investigators
Nicklas Oscarsson
MD
Göteborg University