Reduction of Venous Emboli Load After Breathing Normobaric Oxygen Compared to Air
Primary Purpose
Hyperbaric, Diving Medicine, Decompression Sickness
Status
Completed
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
Oxygen
Air
Sponsored by
About this trial
This is an interventional prevention trial for Hyperbaric
Eligibility Criteria
Inclusion Criteria:
- Professional diver
- Fit to dive according to Swedish Navy standards
Exclusion Criteria:
- NONE
Sites / Locations
- Sahlgrenska University Hospital
- Kungliga Tekniska Högskolan
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Experimental
Arm Label
Air
Oxygen
Arm Description
Normobaric air breathing
Normobaric oxygen breathing
Outcomes
Primary Outcome Measures
Venous gas emboli
Kisman-Masurel grading
Secondary Outcome Measures
Inflammatory activity and endothelial dysfunction
E.g. VCAM-1, ICAM-1
Decompression sickness
Clinical diagnosis
Markers of central nervous system injury
E.g. GFAP, Tau, NfL, UCHL-1
Full Information
NCT ID
NCT02468752
First Posted
June 3, 2015
Last Updated
May 25, 2022
Sponsor
Göteborg University
Collaborators
Swedish Armed Forces Diving and Naval Medicine Centre, KTH Royal Institute of Technology, Sahlgrenska University Hospital, Sweden
1. Study Identification
Unique Protocol Identification Number
NCT02468752
Brief Title
Reduction of Venous Emboli Load After Breathing Normobaric Oxygen Compared to Air
Official Title
Mängden kvävgasbubblor i Blodet Efter Dykning Vid Syrgasandning jämfört Med Luftandning
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
May 2015 (Actual)
Primary Completion Date
April 2019 (Actual)
Study Completion Date
April 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Göteborg University
Collaborators
Swedish Armed Forces Diving and Naval Medicine Centre, KTH Royal Institute of Technology, Sahlgrenska University Hospital, Sweden
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperbaric, Diving Medicine, Decompression Sickness, Central Nervous Injury, Inflammation, Endothelial Dysfunction
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Air
Arm Type
Sham Comparator
Arm Description
Normobaric air breathing
Arm Title
Oxygen
Arm Type
Experimental
Arm Description
Normobaric oxygen breathing
Intervention Type
Drug
Intervention Name(s)
Oxygen
Intervention Type
Other
Intervention Name(s)
Air
Primary Outcome Measure Information:
Title
Venous gas emboli
Description
Kisman-Masurel grading
Time Frame
120 minutes
Secondary Outcome Measure Information:
Title
Inflammatory activity and endothelial dysfunction
Description
E.g. VCAM-1, ICAM-1
Time Frame
120 minutes/ 48 hours
Title
Decompression sickness
Description
Clinical diagnosis
Time Frame
24 hours
Title
Markers of central nervous system injury
Description
E.g. GFAP, Tau, NfL, UCHL-1
Time Frame
120 minutes/ 48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Professional diver
Fit to dive according to Swedish Navy standards
Exclusion Criteria:
NONE
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mikael Gennser, PhD
Organizational Affiliation
Kungliga Tekniska Högskolan, Stockholm, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sahlgrenska University Hospital
City
Gothenburg
ZIP/Postal Code
S-416 85
Country
Sweden
Facility Name
Kungliga Tekniska Högskolan
City
Stockholm
ZIP/Postal Code
S-100 44
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
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Reduction of Venous Emboli Load After Breathing Normobaric Oxygen Compared to Air
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