An interventional study of Hyperbaric Oxygen (1.5 atm abs) and Sham Chamber Session in Traumatic Brain Injury, sponsored by Intermountain Health Care, Inc.. Completed at 2 sites in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-02-15.
Sponsored by Intermountain Health Care, Inc. · Not applicable and Interventional
SCUBA divers and chamber inside attendants will undergo a brief hyperbaric chamber excursion and will be asked to what chamber pressure they were compressed and what gas they breathed.
In clinical trials evaluating hyperbaric oxygen, blinding can be challenging. Options for participant blinding include offering regular air at a lower pressure than the hyperbaric oxygen intervention, or compressing all participants to the same pressure but providing different gas mixes to the active and sham arms.
In some trials of hyperbaric oxygen for brain injury, investigators offer a sham chamber session (regular air at 1.2 atmospheres absolute [atm abs]) compared to the active intervention, hyperbaric oxygen (100% oxygen at 1.5 atm abs). It is unknown whether individuals familiar with pressure changes, such as divers and hyperbaric chamber inside attendants, could discern the difference between these pressures and thereby become unblinded to study allocation.
In this study, 80 experienced divers and chamber inside attendants will be enrolled and randomly assigned to one of four possible chamber pressures and one of two breathing gases. After a brief hyperbaric chamber excursion, they will be asked to what chamber pressure they were compressed and what gas they breathed. If participants can accurately report chamber pressure or breathing gas, pressure-familiar individuals should be excluded from blinded clinical trials of hyperbaric oxygen.
2,112 studies on the registry are indexed under Brain Injuries; 384 are open to participants now.
This study's enrollment of 42 is below the median of 48 across 1,331 interventional studies indexed under Brain Injuries.
Browse Brain Injuries studies →Intermountain Health Care, Inc. is the lead sponsor of 118 studies on the registry; 15 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 3 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Sham Chamber Session Sea Level Equivalent 1.2 atm abs (2.6 psig) breathing regular air 20-chamber excursion
Drug: Sham Chamber Session
Hyperbaric Oxygen (1.5 atm abs) Sea Level Equivalent 1.5 atm abs (6.2 psig) breathing 100% oxygen 20-minute chamber excursion
Drug: Hyperbaric Oxygen (1.5 atm abs)
Sham Chamber Session Altitude Equivalent 1.2 atm abs (5.1 psig) breathing regular air 20-minute chamber excursion
Drug: Sham Chamber Session
Hyperbaric Oxygen (1.5 atm abs) Altitude Equivalent 1.5 atm abs (9.6 psig) breathing 100% oxygen 20-minute chamber excursion
Drug: Hyperbaric Oxygen (1.5 atm abs)
Hyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs.
Also known as: HBO2, HBO, HBOT
Sham control chamber session: regular air delivered at a chamber pressure of 1.2 atm abs
Also known as: Sham control, Air pressurization
Participants Indicating "I do Not Know" on Depth Questionnaire.
Participants indicating "I do not know" on depth questionnaire instead of providing a free response guess.
Time frame: Within 15 minutes of chamber excursion
Participant Perception of Depth
Mean depth perception for participants providing a free response.
Time frame: Within 15 minutes of chamber excursion
Participant Perception of Breathing Gas
Percent of participants in each arm guessing that their breathing gas was 100% oxygen.
Time frame: Within 15 minutes of chamber excursion
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.
| Milestone | Altitude Equivalent 1.2 Atm Abs (Air) | Altitude Equivalent 1.5 Atm Abs (O2) | Sea Level Equivalent 1.2 Atm Abs (Air) | Sea Level Equivalent 1.5 Atm Abs (O2) |
|---|---|---|---|---|
| Started | 10 | 12 | 8 | 12 |
| Completed | 10 | 12 | 8 | 12 |
| Not completed | 0 | 0 | 0 | 0 |
Participants indicating "I do not know" on depth questionnaire instead of providing a free response guess.
| participants | Altitude Equivalent 1.2 Atm Abs (Air) | Altitude Equivalent 1.5 Atm Abs (O2) | Sea Level Equivalent 1.2 Atm Abs (Air) | Sea Level Equivalent 1.5 Atm Abs (O2) |
|---|---|---|---|---|
| Participants Indicating "I do Not Know" on Depth Questionnaire. | 7 | 4 | 4 | 4 |
Mean depth perception for participants providing a free response.
| fsw | Altitude Equivalent 1.2 Atm Abs (Air) | Altitude Equivalent 1.5 Atm Abs (O2) | Sea Level Equivalent 1.2 Atm Abs (Air) | Sea Level Equivalent 1.5 Atm Abs (O2) |
|---|---|---|---|---|
| Participant Perception of Depth | 65 ± 13 | 35 ± 16 | 23 ± 12 | 23 ± 14 |
Percent of participants in each arm guessing that their breathing gas was 100% oxygen.
| percentage of participants | Altitude Equivalent 1.2 Atm Abs (Air) | Altitude Equivalent 1.5 Atm Abs (O2) | Sea Level Equivalent 1.2 Atm Abs (Air) | Sea Level Equivalent 1.5 Atm Abs (O2) |
|---|---|---|---|---|
| Participant Perception of Breathing Gas | 80 | 91 | 88 | 67 |
Collected over Adverse events were collected from the time that participants signed consent until they departed after the chamber excursion (approximately 1 hour).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Altitude Equivalent 1.2 Atm Abs (Air) | — | 0/10 (0%) | 1/10 (10%) |
| Altitude Equivalent 1.5 Atm Abs (O2) | — | 0/12 (0%) | 0/12 (0%) |
| Sea Level Equivalent 1.2 Atm Abs (Air) | — | 0/8 (0%) | 0/8 (0%) |
| Sea Level Equivalent 1.5 Atm Abs (O2) | — | 0/12 (0%) | 0/12 (0%) |
| Event | Altitude Equivalent 1.2 Atm Abs (Air) | Altitude Equivalent 1.5 Atm Abs (O2) | Sea Level Equivalent 1.2 Atm Abs (Air) | Sea Level Equivalent 1.5 Atm Abs (O2) |
|---|---|---|---|---|
| HeadacheNervous system disorders | 1/10 | 0/12 | 0/8 | 0/12 |
| Age, Categorical(Participants) | Altitude Equivalent 1.2 Atm Abs (Air) | Altitude Equivalent 1.5 Atm Abs (O2) | Sea Level Equivalent 1.2 Atm Abs (Air) | Sea Level Equivalent 1.5 Atm Abs (O2) | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 10 | 12 | 8 | 12 | 42 |
| >=65 years | 0 | 0 | 0 | 0 | 0 |
| Age Continuous(years) | Altitude Equivalent 1.2 Atm Abs (Air) | Altitude Equivalent 1.5 Atm Abs (O2) | Sea Level Equivalent 1.2 Atm Abs (Air) | Sea Level Equivalent 1.5 Atm Abs (O2) | Total |
|---|---|---|---|---|---|
| Mean | 45 ± 10 | 49 ± 7.8 | 47 ± 9.3 | 45 ± 13 | 46 ± 10 |
| Sex: Female, Male(Participants) | Altitude Equivalent 1.2 Atm Abs (Air) | Altitude Equivalent 1.5 Atm Abs (O2) | Sea Level Equivalent 1.2 Atm Abs (Air) | Sea Level Equivalent 1.5 Atm Abs (O2) | Total |
|---|---|---|---|---|---|
| Female | 3 | 2 | 1 | 4 | 10 |
| Male | 7 | 10 | 7 | 8 | 32 |
| Region of Enrollment(participants) | Altitude Equivalent 1.2 Atm Abs (Air) | Altitude Equivalent 1.5 Atm Abs (O2) | Sea Level Equivalent 1.2 Atm Abs (Air) | Sea Level Equivalent 1.5 Atm Abs (O2) | Total |
|---|---|---|---|---|---|
| United States | 10 | 12 | 8 | 12 | 42 |
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Intermountain Health Care, Inc.