Trial Outcomes & Findings for Nitrogen Bubble Detection After Simulated Dives in Divers With PFO and After PFO Closure (NCT NCT01854281)
NCT ID: NCT01854281
Last Updated: 2013-12-18
Results Overview
Arterial gas bubbles are detected by transcranial doppler ultrasonography. Positive outcome is 1 or more bubbles detected.
Recruitment status
COMPLETED
Target enrollment
47 participants
Primary outcome timeframe
assesed within 1 hour after surfacing
Results posted on
2013-12-18
Participant Flow
All participants were included consecutively in the Hyperbaric chamber of the Regional hospital Kladno, Kladno, Czech Republic and at Hyperbaric chamber Vyškov, Vyškov, Czech Republic, where they performed a training dive. Two dive profiles were performed (dive A and Dive B). The recruitment took part between 15/May/2013 and 15/June/2013.
No participants were excluded from the study, all enrolled participants completed the study, no transition between groups occured.
Participant milestones
| Measure |
Closure Dive A Group
Divers with a patent foramen ovale previously closed by a catheter-based procedure observed after Dive A.
|
Patent Foramen Ovale Dive A Group
Divers with a previously diagnosed patent foramen ovale observed after Dive A.
|
Closure Dive B Group
Divers with a patent foramen ovale previously closed by a catheter-based procedure observed after Dive B.
|
Patent Foramen Ovale Dive B Group
Divers with a previously diagnosed patent foramen ovale observed after Dive B.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
19
|
5
|
8
|
|
Overall Study
COMPLETED
|
15
|
19
|
5
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nitrogen Bubble Detection After Simulated Dives in Divers With PFO and After PFO Closure
Baseline characteristics by cohort
| Measure |
Closure Dive A Group
n=15 Participants
Divers with a patent foramen ovale previously closed by a catheter-based procedure observed after Dive A.
|
Patent Foramen Ovale Dive A Group
n=19 Participants
Divers with a previously diagnosed patent foramen ovale observed after dive A.
|
Closure Dive B Group
n=5 Participants
Divers with a patent foramen ovale previously closed by a catheter-based procedure observed after Dive B.
|
Patent Foramen Ovale Dive B Group
n=8 Participants
Divers with a previously diagnosed patent foramen ovale observed after dive B.
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
47 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age Continuous
|
41 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
33 years
STANDARD_DEVIATION 7.6 • n=7 Participants
|
33 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
33 years
STANDARD_DEVIATION 4.8 • n=4 Participants
|
35 years
STANDARD_DEVIATION 8.6 • n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
38 Participants
n=21 Participants
|
|
Region of Enrollment
Czech Republic
|
15 participants
n=5 Participants
|
19 participants
n=7 Participants
|
5 participants
n=5 Participants
|
8 participants
n=4 Participants
|
47 participants
n=21 Participants
|
|
Body mass index
|
27.3 kg/m2
STANDARD_DEVIATION 3.9 • n=5 Participants
|
25.9 kg/m2
STANDARD_DEVIATION 4.2 • n=7 Participants
|
28.3 kg/m2
STANDARD_DEVIATION 5.7 • n=5 Participants
|
25.2 kg/m2
STANDARD_DEVIATION 2.2 • n=4 Participants
|
26.3 kg/m2
STANDARD_DEVIATION 3.9 • n=21 Participants
|
|
Number of dives
|
1237 Dives
STANDARD_DEVIATION 1762 • n=5 Participants
|
412 Dives
STANDARD_DEVIATION 984 • n=7 Participants
|
998 Dives
STANDARD_DEVIATION 1851 • n=5 Participants
|
191 Dives
STANDARD_DEVIATION 339 • n=4 Participants
|
622 Dives
STANDARD_DEVIATION 1238 • n=21 Participants
|
|
Number of decompression dives
|
251 Dives
STANDARD_DEVIATION 314 • n=5 Participants
|
70 Dives
STANDARD_DEVIATION 180 • n=7 Participants
|
150 Dives
STANDARD_DEVIATION 162 • n=5 Participants
|
44 Dives
STANDARD_DEVIATION 82 • n=4 Participants
|
127 Dives
STANDARD_DEVIATION 228 • n=21 Participants
|
|
history of decompression sickness
|
14 participants
n=5 Participants
|
10 participants
n=7 Participants
|
4 participants
n=5 Participants
|
3 participants
n=4 Participants
|
31 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: assesed within 1 hour after surfacingArterial gas bubbles are detected by transcranial doppler ultrasonography. Positive outcome is 1 or more bubbles detected.
Outcome measures
| Measure |
Closure Dive A Group
n=15 Participants
Divers with a patent foramen ovale previously closed by a catheter-based procedure observed after Dive A.
|
Patent Foramen Ovale Dive A Group
n=19 Participants
Divers with a previously diagnosed patent foramen ovale observed after dive A.
|
Closure Dive B Group
n=5 Participants
Divers with a patent foramen ovale previously closed by a catheter-based procedure observed after Dive B.
|
Patent Foramen Ovale Dive B Group
n=8 Participants
Divers with a previously diagnosed patent foramen ovale observed after dive B.
|
|---|---|---|---|---|
|
Arterial Nitrogen Bubbles After Surfacing
|
0 participants
|
6 participants
|
0 participants
|
7 participants
|
Adverse Events
Closure Dive A Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Patent Foramen Ovale Dive A Group
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Closure Dive B Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Patent Foramen Ovale Dive B Group
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Closure Dive A Group
n=15 participants at risk
Divers with a patent foramen ovale previously closed by a catheter-based procedure observed after Dive A.
|
Patent Foramen Ovale Dive A Group
n=19 participants at risk
Divers with a previously diagnosed patent foramen ovale observed after dive A.
|
Closure Dive B Group
n=5 participants at risk
Divers with a patent foramen ovale previously closed by a catheter-based procedure observed after Dive B.
|
Patent Foramen Ovale Dive B Group
n=8 participants at risk
Divers with a previously diagnosed patent foramen ovale observed after dive B.
|
|---|---|---|---|---|
|
Nervous system disorders
Mild neurological symptoms of decompression sickness
|
0.00%
0/15
|
21.1%
4/19 • Number of events 4
|
0.00%
0/5
|
25.0%
2/8 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place