Trial Outcomes & Findings for Test of Chamber Pressure to Divers and Chamber Attendants (NCT NCT01430325)
NCT ID: NCT01430325
Last Updated: 2013-02-15
Results Overview
Participants indicating "I do not know" on depth questionnaire instead of providing a free response guess.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
42 participants
Primary outcome timeframe
Within 15 minutes of chamber excursion
Results posted on
2013-02-15
Participant Flow
82 individuals responded to study announcements and were pre-screened by telephone, of which 25 were deemed ineligible (due to inadequate diving experience). An additional 15 individuals declined to participate (primarily due to scheduling conflicts). 42 divers and chamber inside attendants signed informed consent and participated in the study.
All participants signing informed consent continued to group assignment.
Participant milestones
| Measure |
Altitude Equivalent 1.2 Atm Abs (Air)
Altitude Equivalent 1.2 atm abs (5.1 psig) breathing regular air 20-minute chamber excursion
Sham Chamber Session : Sham control chamber session: regular air delivered at a chamber pressure of 1.2 atm abs
|
Altitude Equivalent 1.5 Atm Abs (O2)
Altitude Equivalent 1.5 atm abs (9.6 psig) breathing 100% oxygen 20-minute chamber excursion
Hyperbaric Oxygen (1.5 atm abs) : Hyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs.
|
Sea Level Equivalent 1.2 Atm Abs (Air)
Sea Level Equivalent 1.2 atm abs (2.6 psig) breathing regular air 20-chamber excursion
Sham Chamber Session : Sham control chamber session: regular air delivered at a chamber pressure of 1.2 atm abs
|
Sea Level Equivalent 1.5 Atm Abs (O2)
Sea Level Equivalent 1.5 atm abs (6.2 psig) breathing 100% oxygen 20-minute chamber excursion
Hyperbaric Oxygen (1.5 atm abs) : Hyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
12
|
8
|
12
|
|
Overall Study
COMPLETED
|
10
|
12
|
8
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Test of Chamber Pressure to Divers and Chamber Attendants
Baseline characteristics by cohort
| Measure |
Altitude Equivalent 1.2 Atm Abs (Air)
n=10 Participants
Altitude Equivalent 1.2 atm abs (5.1 psig) breathing regular air 20-minute chamber excursion
Sham Chamber Session : Sham control chamber session: regular air delivered at a chamber pressure of 1.2 atm abs
|
Altitude Equivalent 1.5 Atm Abs (O2)
n=12 Participants
Altitude Equivalent 1.5 atm abs (9.6 psig) breathing 100% oxygen 20-minute chamber excursion
Hyperbaric Oxygen (1.5 atm abs) : Hyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs.
|
Sea Level Equivalent 1.2 Atm Abs (Air)
n=8 Participants
Sea Level Equivalent 1.2 atm abs (2.6 psig) breathing regular air 20-chamber excursion
Sham Chamber Session : Sham control chamber session: regular air delivered at a chamber pressure of 1.2 atm abs
|
Sea Level Equivalent 1.5 Atm Abs (O2)
n=12 Participants
Sea Level Equivalent 1.5 atm abs (6.2 psig) breathing 100% oxygen 20-minute chamber excursion
Hyperbaric Oxygen (1.5 atm abs) : Hyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs.
|
Total
n=42 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
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
42 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
|
45 years
STANDARD_DEVIATION 10 • n=5 Participants
|
49 years
STANDARD_DEVIATION 7.8 • n=7 Participants
|
47 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
45 years
STANDARD_DEVIATION 13 • n=4 Participants
|
46 years
STANDARD_DEVIATION 10 • n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
12 participants
n=7 Participants
|
8 participants
n=5 Participants
|
12 participants
n=4 Participants
|
42 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Within 15 minutes of chamber excursionPopulation: All participants who enrolled in the study were analyzed.
Participants indicating "I do not know" on depth questionnaire instead of providing a free response guess.
Outcome measures
| Measure |
Altitude Equivalent 1.2 Atm Abs (Air)
n=10 Participants
Altitude Equivalent 1.2 atm abs (5.1 psig) breathing regular air 20-minute chamber excursion
Sham Chamber Session : Sham control chamber session: regular air delivered at a chamber pressure of 1.2 atm abs
|
Altitude Equivalent 1.5 Atm Abs (O2)
n=12 Participants
Altitude Equivalent 1.5 atm abs (9.6 psig) breathing 100% oxygen 20-minute chamber excursion
Hyperbaric Oxygen (1.5 atm abs) : Hyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs.
|
Sea Level Equivalent 1.2 Atm Abs (Air)
n=8 Participants
Sea Level Equivalent 1.2 atm abs (2.6 psig) breathing regular air 20-chamber excursion
Sham Chamber Session : Sham control chamber session: regular air delivered at a chamber pressure of 1.2 atm abs
|
Sea Level Equivalent 1.5 Atm Abs (O2)
n=12 Participants
Sea Level Equivalent 1.5 atm abs (6.2 psig) breathing 100% oxygen 20-minute chamber excursion
Hyperbaric Oxygen (1.5 atm abs) : Hyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs.
|
|---|---|---|---|---|
|
Participants Indicating "I do Not Know" on Depth Questionnaire.
|
7 participants
|
4 participants
|
4 participants
|
4 participants
|
PRIMARY outcome
Timeframe: Within 15 minutes of chamber excursionPopulation: 23 of 42 participants provided a numerical response. The remainder selected "I do not know."
Mean depth perception for participants providing a free response.
Outcome measures
| Measure |
Altitude Equivalent 1.2 Atm Abs (Air)
n=4 Participants
Altitude Equivalent 1.2 atm abs (5.1 psig) breathing regular air 20-minute chamber excursion
Sham Chamber Session : Sham control chamber session: regular air delivered at a chamber pressure of 1.2 atm abs
|
Altitude Equivalent 1.5 Atm Abs (O2)
n=8 Participants
Altitude Equivalent 1.5 atm abs (9.6 psig) breathing 100% oxygen 20-minute chamber excursion
Hyperbaric Oxygen (1.5 atm abs) : Hyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs.
|
Sea Level Equivalent 1.2 Atm Abs (Air)
n=4 Participants
Sea Level Equivalent 1.2 atm abs (2.6 psig) breathing regular air 20-chamber excursion
Sham Chamber Session : Sham control chamber session: regular air delivered at a chamber pressure of 1.2 atm abs
|
Sea Level Equivalent 1.5 Atm Abs (O2)
n=7 Participants
Sea Level Equivalent 1.5 atm abs (6.2 psig) breathing 100% oxygen 20-minute chamber excursion
Hyperbaric Oxygen (1.5 atm abs) : Hyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs.
|
|---|---|---|---|---|
|
Participant Perception of Depth
|
65 fsw
Standard Deviation 13
|
35 fsw
Standard Deviation 16
|
23 fsw
Standard Deviation 12
|
23 fsw
Standard Deviation 14
|
PRIMARY outcome
Timeframe: Within 15 minutes of chamber excursionPopulation: 40 of 42 participants provided an answer to this question.
Percent of participants in each arm guessing that their breathing gas was 100% oxygen.
Outcome measures
| Measure |
Altitude Equivalent 1.2 Atm Abs (Air)
n=10 Participants
Altitude Equivalent 1.2 atm abs (5.1 psig) breathing regular air 20-minute chamber excursion
Sham Chamber Session : Sham control chamber session: regular air delivered at a chamber pressure of 1.2 atm abs
|
Altitude Equivalent 1.5 Atm Abs (O2)
n=11 Participants
Altitude Equivalent 1.5 atm abs (9.6 psig) breathing 100% oxygen 20-minute chamber excursion
Hyperbaric Oxygen (1.5 atm abs) : Hyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs.
|
Sea Level Equivalent 1.2 Atm Abs (Air)
n=8 Participants
Sea Level Equivalent 1.2 atm abs (2.6 psig) breathing regular air 20-chamber excursion
Sham Chamber Session : Sham control chamber session: regular air delivered at a chamber pressure of 1.2 atm abs
|
Sea Level Equivalent 1.5 Atm Abs (O2)
n=11 Participants
Sea Level Equivalent 1.5 atm abs (6.2 psig) breathing 100% oxygen 20-minute chamber excursion
Hyperbaric Oxygen (1.5 atm abs) : Hyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs.
|
|---|---|---|---|---|
|
Participant Perception of Breathing Gas
|
80 percentage of participants
|
91 percentage of participants
|
88 percentage of participants
|
67 percentage of participants
|
Adverse Events
Altitude Equivalent 1.2 Atm Abs (Air)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Altitude Equivalent 1.5 Atm Abs (O2)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sea Level Equivalent 1.2 Atm Abs (Air)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sea Level Equivalent 1.5 Atm Abs (O2)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Altitude Equivalent 1.2 Atm Abs (Air)
n=10 participants at risk
Altitude Equivalent 1.2 atm abs (5.1 psig) breathing regular air 20-minute chamber excursion
Sham Chamber Session : Sham control chamber session: regular air delivered at a chamber pressure of 1.2 atm abs
|
Altitude Equivalent 1.5 Atm Abs (O2)
n=12 participants at risk
Altitude Equivalent 1.5 atm abs (9.6 psig) breathing 100% oxygen 20-minute chamber excursion
Hyperbaric Oxygen (1.5 atm abs) : Hyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs.
|
Sea Level Equivalent 1.2 Atm Abs (Air)
n=8 participants at risk
Sea Level Equivalent 1.2 atm abs (2.6 psig) breathing regular air 20-chamber excursion
Sham Chamber Session : Sham control chamber session: regular air delivered at a chamber pressure of 1.2 atm abs
|
Sea Level Equivalent 1.5 Atm Abs (O2)
n=12 participants at risk
Sea Level Equivalent 1.5 atm abs (6.2 psig) breathing 100% oxygen 20-minute chamber excursion
Hyperbaric Oxygen (1.5 atm abs) : Hyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs.
|
|---|---|---|---|---|
|
Nervous system disorders
Headache
|
10.0%
1/10 • Number of events 1 • Adverse events were collected from the time that participants signed consent until they departed after the chamber excursion (approximately 1 hour).
|
0.00%
0/12 • Adverse events were collected from the time that participants signed consent until they departed after the chamber excursion (approximately 1 hour).
|
0.00%
0/8 • Adverse events were collected from the time that participants signed consent until they departed after the chamber excursion (approximately 1 hour).
|
0.00%
0/12 • Adverse events were collected from the time that participants signed consent until they departed after the chamber excursion (approximately 1 hour).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place