Reduction of Venous Emboli Load After Breathing Normobaric Oxygen Compared to Air
NCT ID: NCT02468752
Last Updated: 2022-05-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
48 participants
INTERVENTIONAL
2015-05-31
2019-04-30
Brief Summary
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\- 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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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
TRIPLE
Study Groups
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Air
Normobaric air breathing
Air
Oxygen
Normobaric oxygen breathing
Oxygen
Interventions
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Oxygen
Air
Eligibility Criteria
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Inclusion Criteria
* Fit to dive according to Swedish Navy standards
Exclusion Criteria
18 Years
65 Years
ALL
Yes
Sponsors
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Swedish Armed Forces Diving and Naval Medicine Centre
OTHER
KTH Royal Institute of Technology
OTHER
Sahlgrenska University Hospital
OTHER
Göteborg University
OTHER
Responsible Party
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Nicklas Oscarsson
MD
Principal Investigators
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Mikael Gennser, PhD
Role: PRINCIPAL_INVESTIGATOR
Kungliga Tekniska Högskolan, Stockholm, Sweden
Locations
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Sahlgrenska University Hospital
Gothenburg, , Sweden
Kungliga Tekniska Högskolan
Stockholm, , Sweden
Countries
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Other Identifiers
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DYK 14-16
Identifier Type: -
Identifier Source: org_study_id
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