Traumatic Brain InjuryTOP-DIVERNCT01430325

Test of Chamber Pressure to Divers and Chamber Attendants

A study testing Hyperbaric Oxygen (1.5 atm abs) in people with Traumatic Brain Injury, run by Intermountain Health Care, Inc. at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Traumatic Brain Injury
What is being tested?: Hyperbaric Oxygen (1.5 atm abs)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 42 participants
Where: 2 sitesUnited States
Study dates: Jul 2011to Oct 2011
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Adult, age 18 - 65 years
Completion of medical history questionnaire without concerns identified for exposure to increased pressure
Familiarity with atmospheric pressure change:
Experienced and active hyperbaric chamber inside attendant: more than 50 hyperbaric compressions, with more than 4 have been in the last 4 months; or
Experienced and active SCUBA diver: more than 20 lifetime compressed gas open water (not swimming pool) dives, with more than 10 in the last 12 months
Able to equalize middle ear pressure easily

Who cannot join

Pregnancy
Known risk for barotrauma, as identified on the medical history questionnaire, such as:
Recent (within 12 months) inner ear or sinus surgery
Spontaneous pneumothorax
Pulmonary cysts
Emphysema

Show all 12Show fewer

Bullous lung disease
Chronic obstructive pulmonary disease needing chronic active therapy
Inability to tolerate chamber confinement or pressure
Presence of heart failure
Presence of any implanted electrical device, except hyperbaric-approved pacemakers
Presence of middle-ear tympanostomy tubes

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Intermountain Medical Center
Murray, Utah, 84107
LDS Hospital
Salt Lake City, Utah, 84143

Other trials in United States

About this study

Official title: Test of Chamber Pressure to Divers and Chamber Attendants: A Blinded Trial to Investigate if "Pressure-familiar" Individuals Can Determine Pressure

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.

Read the detailed description

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.

Conditions: Traumatic Brain Injury
Being tested: Hyperbaric Oxygen (1.5 atm abs), Sham Chamber Session
Keywords: Hyperbaric oxygen
Medical subject headings: Brain Injuries, Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Hyperbaric Oxygen (1.5 atm abs)Drug
Also called HBO2, HBO, HBOT
Hyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs.
Sham Chamber SessionDrug
Also called Sham control, Air pressurization
Sham control chamber session: regular air delivered at a chamber pressure of 1.2 atm abs

Study groups in NCT01430325
Study group	Role	What they receive
Sea Level Equivalent 1.2 atm abs (air)	Sham comparator	Sham Chamber Session Sea Level Equivalent 1.2 atm abs (2.6 psig) breathing regular air 20-chamber excursion Receives: Drug: Sham Chamber Session
Sea Level Equivalent 1.5 atm abs (O2)	Experimental	Hyperbaric Oxygen (1.5 atm abs) Sea Level Equivalent 1.5 atm abs (6.2 psig) breathing 100% oxygen 20-minute chamber excursion Receives: Drug: Hyperbaric Oxygen (1.5 atm abs)
Altitude Equivalent 1.2 atm abs (air)	Sham comparator	Sham Chamber Session Altitude Equivalent 1.2 atm abs (5.1 psig) breathing regular air 20-minute chamber excursion Receives: Drug: Sham Chamber Session
Altitude Equivalent 1.5 atm abs (O2)	Experimental	Hyperbaric Oxygen (1.5 atm abs) Altitude Equivalent 1.5 atm abs (9.6 psig) breathing 100% oxygen 20-minute chamber excursion Receives: Drug: Hyperbaric Oxygen (1.5 atm abs)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Within 15 minutes of chamber excursion
Participant Perception of Depth
Mean depth perception for participants providing a free response.
Measured: 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.
Measured: Within 15 minutes of chamber excursion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2011Oct 2011

First posted8 Sep 2011 (estimated)
Study startJul 2011
Primary completionOct 2011
Study completionOct 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Allocation: Randomised
Intervention model: Single group
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01430325
Sponsor's protocol ID: 1023955
Acronym: TOP-DIVER
Status last verified: Dec 2012
First submitted: 2 Sep 2011
Last updated: 15 Feb 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Clarke D. Effective patient blinding during hyperbaric trials. Undersea Hyperb Med. 2009 Jan-Feb;36(1):13-7.
PubMed 19341123
Jansen T, Mortensen CR, Tvede MF. It is possible to perform a double-blind hyperbaric session: a double-blinded randomized trial performed on healthy volunteers. Undersea Hyperb Med. 2009 Sep-Oct;36(5):347-51.
PubMed 20112525
Weaver LK, Hopkins RO, Churchill S, Haberstock D. Double-Blinding is Possible in Hyperbaric Oxygen (HBO2) Randomized Clinical Trials (RCT) Using a Minimal Chamber Pressurization as Control. Undersea Hyperb Med 1997;24(Suppl):36.
Weaver LK, Churchill SK, Bell J, Deru K, Snow GL. A blinded trial to investigate whether 'pressure-familiar' individuals can determine chamber pressure. Undersea Hyperb Med. 2012 Jul-Aug;39(4):801-5.
PubMed 22908836

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
RecruitingObservational study
Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
Moderate Traumatic Brain Injury
Not yet recruitingPhase 1
Nanopulse Laser Therapy
TBI (Traumatic Brain Injury)
RecruitingObservational study
Effect of Different Intravenous Fluids on Post-operative Chronic Subdural Hematoma Size and Recurrence
Chronic Subdural Hematoma

All Traumatic Brain Injury trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Test of Chamber Pressure to Divers and Chamber Attendants: A Blinded Trial to Investigate if "Pressure-familiar" Individuals Can Determine Pressure
ClinicalTrials.gov ID: NCT01430325
Acronym / sponsor ID: TOP-DIVER / 1023955
Conditions: Traumatic Brain Injury
Keywords: Hyperbaric oxygen
Study type: Interventional
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: Intermountain Health Care, Inc.University, hospital or other
Study start: Jul 2011
Primary completion: Oct 2011 (actual)
Study completion: Oct 2011 (actual)
First posted: 8 Sep 2011 (estimated)
Results: Posted 7 Feb 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Allocation: Randomised
Intervention model: Single group
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Sea Level Equivalent 1.2 atm abs (air)	Sham comparator	Drug: Sham Chamber SessionSham Chamber Session Sea Level Equivalent 1.2 atm abs (2.6 psig) breathing regular air 20-chamber excursion
Sea Level Equivalent 1.5 atm abs (O2)	Experimental	Drug: Hyperbaric Oxygen (1.5 atm abs)Hyperbaric Oxygen (1.5 atm abs) Sea Level Equivalent 1.5 atm abs (6.2 psig) breathing 100% oxygen 20-minute chamber excursion
Altitude Equivalent 1.2 atm abs (air)	Sham comparator	Drug: Sham Chamber SessionSham Chamber Session Altitude Equivalent 1.2 atm abs (5.1 psig) breathing regular air 20-minute chamber excursion
Altitude Equivalent 1.5 atm abs (O2)	Experimental	Drug: Hyperbaric Oxygen (1.5 atm abs)Hyperbaric Oxygen (1.5 atm abs) Altitude Equivalent 1.5 atm abs (9.6 psig) breathing 100% oxygen 20-minute chamber excursion

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Adult, age 18 - 65 years
Completion of medical history questionnaire without concerns identified for exposure to increased pressure
Familiarity with atmospheric pressure change:
Experienced and active hyperbaric chamber inside attendant: more than 50 hyperbaric compressions, with more than 4 have been in the last 4 months; or
Experienced and active SCUBA diver: more than 20 lifetime compressed gas open water (not swimming pool) dives, with more than 10 in the last 12 months

Key exclusion criteria (12 listed)

Pregnancy
Known risk for barotrauma, as identified on the medical history questionnaire, such as:
Recent (within 12 months) inner ear or sinus surgery
Spontaneous pneumothorax
Pulmonary cysts

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Hyperbaric Oxygen (1.5 atm abs)Also: HBO2, HBO, HBOTHyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs.	Drug	Altitude Equivalent 1.5 atm abs (O2), Sea Level Equivalent 1.5 atm abs (O2)
Sham Chamber SessionAlso: Sham control, Air pressurizationSham control chamber session: regular air delivered at a chamber pressure of 1.2 atm abs	Drug	Altitude Equivalent 1.2 atm abs (air), Sea Level Equivalent 1.2 atm abs (air)

Primary outcome

Participants Indicating "I do Not Know" on Depth Questionnaire.
Time frame: Within 15 minutes of chamber excursion
Participants indicating "I do not know" on depth questionnaire instead of providing a free response guess.
Participant Perception of Depth
Time frame: Within 15 minutes of chamber excursion
Mean depth perception for participants providing a free response.
Participant Perception of Breathing Gas
Time frame: Within 15 minutes of chamber excursion
Percent of participants in each arm guessing that their breathing gas was 100% oxygen.

Results and safety

Results posted to the registry on 7 Feb 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Altitude Equivalent 1.2 Atm Abs (Air)	10	10
Altitude Equivalent 1.5 Atm Abs (O2)	12	12
Sea Level Equivalent 1.2 Atm Abs (Air)	8	8
Sea Level Equivalent 1.5 Atm Abs (O2)	12	12

Primary outcome: Participants Indicating "I do Not Know" on Depth Questionnaire.

Time frame: Within 15 minutes of chamber excursion. Number. Unit: participants

Measure	Altitude Equivalent 1.2 Atm Abs (Air) n = 10	Altitude Equivalent 1.5 Atm Abs (O2) n = 12	Sea Level Equivalent 1.2 Atm Abs (Air) n = 8	Sea Level Equivalent 1.5 Atm Abs (O2) n = 12
Value	7	4	4	4

Population analysed: All participants who enrolled in the study were analyzed.

Primary outcome: Participant Perception of Depth

Time frame: Within 15 minutes of chamber excursion. Mean (Standard Deviation). Unit: fsw

Measure	Altitude Equivalent 1.2 Atm Abs (Air) n = 4	Altitude Equivalent 1.5 Atm Abs (O2) n = 8	Sea Level Equivalent 1.2 Atm Abs (Air) n = 4	Sea Level Equivalent 1.5 Atm Abs (O2) n = 7
Value	65 (13)	35 (16)	23 (12)	23 (14)

Population analysed: 23 of 42 participants provided a numerical response. The remainder selected "I do not know."

Primary outcome: Participant Perception of Breathing Gas

Time frame: Within 15 minutes of chamber excursion. Number. Unit: percentage of participants

Measure	Altitude Equivalent 1.2 Atm Abs (Air) n = 10	Altitude Equivalent 1.5 Atm Abs (O2) n = 11	Sea Level Equivalent 1.2 Atm Abs (Air) n = 8	Sea Level Equivalent 1.5 Atm Abs (O2) n = 11
Value	80	91	88	67

Population analysed: 40 of 42 participants provided an answer to this question.

Adverse events

Time frame: Adverse events were collected from the time that participants signed consent until they departed after the chamber excursion (approximately 1 hour).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Altitude Equivalent 1.2 Atm Abs (Air)	0 of 10 (0%)	1 of 10 (10%)	Not reported
Altitude Equivalent 1.5 Atm Abs (O2)	0 of 12 (0%)	0 of 12 (0%)	Not reported
Sea Level Equivalent 1.2 Atm Abs (Air)	0 of 8 (0%)	0 of 8 (0%)	Not reported
Sea Level Equivalent 1.5 Atm Abs (O2)	0 of 12 (0%)	0 of 12 (0%)	Not reported

Limitations and caveats (from the sponsor): Smaller sample size; enrollment was stopped at 42 participants when investigators had exhausted the planned recruitment methods. Very few inside attendants enrolled. Pressures in this study were relatively close.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 19341123Clarke D. Effective patient blinding during hyperbaric trials. Undersea Hyperb Med. 2009 Jan-Feb;36(1):13-7.
Background: PubMed 20112525Jansen T, Mortensen CR, Tvede MF. It is possible to perform a double-blind hyperbaric session: a double-blinded randomized trial performed on healthy volunteers. Undersea Hyperb Med. 2009 Sep-Oct;36(5):347-51.
BackgroundWeaver LK, Hopkins RO, Churchill S, Haberstock D. Double-Blinding is Possible in Hyperbaric Oxygen (HBO2) Randomized Clinical Trials (RCT) Using a Minimal Chamber Pressurization as Control. Undersea Hyperb Med 1997;24(Suppl):36.
Results publication: PubMed 22908836Weaver LK, Churchill SK, Bell J, Deru K, Snow GL. A blinded trial to investigate whether 'pressure-familiar' individuals can determine chamber pressure. Undersea Hyperb Med. 2012 Jul-Aug;39(4):801-5.

Related trials for Traumatic Brain Injury

Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
RecruitingObservational study
Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
Moderate Traumatic Brain Injury
Not yet recruitingPhase 1
Nanopulse Laser Therapy
TBI (Traumatic Brain Injury)
RecruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lindell K. Weaver, MD principal investigator

Intermountain Health Care, Inc.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Hyperbaric Oxygen (1.5 atm abs) in people with Traumatic Brain Injury, run by Intermountain Health Care, Inc. at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Feb 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participants Indicating "I do Not Know" on Depth Questionnaire. (time frame: Within 15 minutes of chamber excursion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01430325, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2013.