NCT Number: NCT02468752
Reduction of Venous Emboli Load After Breathing Normobaric Oxygen Compared to Air
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
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Notify MeKey information
Conditions
Age range
18 year–65 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2 / Phase 3
Primary location
Sahlgrenska University Hospital, Gothenburg, Sweden
About this study
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.
TTD measurements were done every five minutes during the first 30 minutes, thereafter every 15 minutes during 90 minutes.
TTE was performed every 30 minutes, using an apical 4-chamber view.
Blood samples were obtained pre-dive, 30-45 minutes post-dive and 120 minutes post-dive.
Set 1: 16 divers, divided into two equal groups (A and B). Dive to 42 msw during 10 min with a safety stop at five msw during three min. Immediately post dive breathing of oxygen (group A) or air (group B) during 30 min. VGE load, time to VGE detection and VGE duration is recorded. Blood samples were obtained pre-dive and 30 and 120 minutes post-dive. After 48 hours, the dives were repeated with switched gases between the groups.
Set 2: 32 divers, divided into two equal groups (A and B). Dive to 42 msw during 10 min with a safety stop at five msw during three min. Fifteen minutes post dive breathing of oxygen (group A) or air (group B) during 30 min. VGE load, time to VGE detection and VGE duration is recorded. Blood samples were obtained pre-dive and 45 and 120 minutes post-dive, from the first 16 divers. After 48 hours, the dives were repeated with switched gases between the groups.
Two further planned sets with repeated diving and shorter duration of oxygen/air-breathing were never carried through.
AE including SAE will be recorded during the study. DCS may be considered either an AE or SAE depending on severity. Ongoing AE and SAE will be followed up.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Professional diver
- Fit to dive according to Swedish Navy standards
Exclusion criteria
- NONE
Treatment and study plan
Air
OtherPrimary outcomes
-
Venous gas emboli
Time frame: 120 minutes
Kisman-Masurel grading
Secondary outcomes
-
Inflammatory activity and endothelial dysfunction
Time frame: 120 minutes/ 48 hours
E.g. VCAM-1, ICAM-1
-
Decompression sickness
Time frame: 24 hours
Clinical diagnosis
-
Markers of central nervous system injury
Time frame: 120 minutes/ 48 hours
E.g. GFAP, Tau, NfL, UCHL-1
Sponsors and collaborators
Lead sponsor
Göteborg University
Other
Collaborators
- KTH Royal Institute of Technology
- Sahlgrenska University Hospital
- Swedish Armed Forces Diving and Naval Medicine Centre
Registry information
Official study title
Mängden kvävgasbubblor i Blodet Efter Dykning Vid Syrgasandning jämfört Med Luftandning
Important dates
- Study start
- 2015
- Primary completion
- 2019
- Study completion
- 2019
- First posted
- Jun 11, 2015
- Registry last updated
- May 27, 2022
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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