Clinical trial NCT02468752: 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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Hyperbaric
Diving Medicine
Decompression Sickness
Central Nervous Injury
Inflammation
Endothelial Dysfunction
Lead sponsor: Göteborg University
Sponsor class: OTHER
Collaborators: name: Swedish Armed Forces Diving and Naval Medicine Centre
name: KTH Royal Institute of Technology
name: Sahlgrenska University Hospital
First posted: 2015-06-11
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* Professional diver
* Fit to dive according to Swedish Navy standards

Exclusion Criteria:

* NONE

Primary outcomes:
measure: Venous gas emboli
timeFrame: 120 minutes
Secondary outcomes:
measure: Inflammatory activity and endothelial dysfunction
timeFrame: 120 minutes/ 48 hours
measure: Decompression sickness
timeFrame: 24 hours
measure: Markers of central nervous system injury
timeFrame: 120 minutes/ 48 hours
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
city: Stockholm
country: Sweden
facility: Kungliga Tekniska Högskolan
Study officials:
affiliation: Kungliga Tekniska Högskolan, Stockholm, Sweden
name: Mikael Gennser, PhD
role: PRINCIPAL_INVESTIGATOR
References: