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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02468752
Other study ID # DYK 14-16
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date May 2015
Est. completion date April 2019

Study information

Verified date May 2022
Source Göteborg University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date April 2019
Est. primary completion date April 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Professional diver - Fit to dive according to Swedish Navy standards Exclusion Criteria: - NONE

Study Design


Intervention

Drug:
Oxygen

Other:
Air


Locations

Country Name City State
Sweden Sahlgrenska University Hospital Gothenburg
Sweden Kungliga Tekniska Högskolan Stockholm

Sponsors (4)

Lead Sponsor Collaborator
Göteborg University KTH Royal Institute of Technology, Sahlgrenska University Hospital, Sweden, Swedish Armed Forces Diving and Naval Medicine Centre

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Venous gas emboli Kisman-Masurel grading 120 minutes
Secondary Inflammatory activity and endothelial dysfunction E.g. VCAM-1, ICAM-1 120 minutes/ 48 hours
Secondary Decompression sickness Clinical diagnosis 24 hours
Secondary Markers of central nervous system injury E.g. GFAP, Tau, NfL, UCHL-1 120 minutes/ 48 hours
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