NCT02468752

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2015

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 3, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 11, 2015

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

May 27, 2022

Status Verified

May 1, 2022

Enrollment Period

3.9 years

First QC Date

June 3, 2015

Last Update Submit

May 25, 2022

Conditions

HyperbaricDiving MedicineDecompression SicknessCentral Nervous InjuryInflammationEndothelial Dysfunction

Outcome Measures

Primary Outcomes (1)

  • Venous gas emboli

    Kisman-Masurel grading

    120 minutes

Secondary Outcomes (3)

  • Inflammatory activity and endothelial dysfunction

    120 minutes/ 48 hours

  • Decompression sickness

    24 hours

  • Markers of central nervous system injury

    120 minutes/ 48 hours

Study Arms (2)

Air

SHAM COMPARATOR

Normobaric air breathing

Other: Air

Oxygen

EXPERIMENTAL

Normobaric oxygen breathing

Drug: Oxygen

Interventions

OxygenDRUG
Oxygen
AirOTHER
Air

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • NONE

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sahlgrenska University Hospital

Gothenburg, S-416 85, Sweden

Location

Kungliga Tekniska Högskolan

Stockholm, S-100 44, Sweden

Location

MeSH Terms

Conditions

Decompression SicknessInflammation

Interventions

OxygenAir

Condition Hierarchy (Ancestors)

BarotraumaWounds and InjuriesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsGasesAtmosphereEnvironmentEcological and Environmental PhenomenaBiological PhenomenaMeteorological ConceptsEnvironment and Public Health

Study Officials

  • Mikael Gennser, PhD

    Kungliga Tekniska Högskolan, Stockholm, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 3, 2015

First Posted

June 11, 2015

Study Start

May 1, 2015

Primary Completion

April 1, 2019

Study Completion

April 1, 2019

Last Updated

May 27, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

SE(2)