Test of Chamber Pressure to Divers and Chamber Attendants

NCT01430325 | Completed Results

• 1 other identifier: 1023955
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Traumatic Brain Injury

Keywords

Hyperbaric oxygen

Outcome Measures

Primary Outcomes (3)

• 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.

  Within 15 minutes of chamber excursion

• Participant Perception of Depth

  Mean depth perception for participants providing a free response.

  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.

  Within 15 minutes of chamber excursion

Study Arms (4)

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

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

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

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

Drug: Hyperbaric Oxygen (1.5 atm abs)

Interventions

Hyperbaric Oxygen (1.5 atm abs) DRUG

Hyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs.

Also known as: HBO2, HBO, HBOT

Altitude Equivalent 1.5 atm abs (O2); Sea Level Equivalent 1.5 atm abs (O2)

Sham Chamber Session DRUG

Sham control chamber session: regular air delivered at a chamber pressure of 1.2 atm abs

Also known as: Sham control, Air pressurization

Altitude Equivalent 1.2 atm abs (air); Sea Level Equivalent 1.2 atm abs (air)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Intermountain Health Care, Inc.: lead

Study Sites (2)

Intermountain Medical Center

Murray, Utah, 84107, United States

Location

LDS Hospital

Salt Lake City, Utah, 84143, United States

Location

Related Publications (4)

• Clarke D. Effective patient blinding during hyperbaric trials. Undersea Hyperb Med. 2009 Jan-Feb;36(1):13-7.

  PMID: 19341123 BACKGROUND

• 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.

  PMID: 20112525 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 22908836 RESULT

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Limitations and Caveats

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.

Results Point of Contact

• Title: Lindell K. Weaver, MD
• Organization: Intermountain Healthcare

lindell.weaver@imail.org

801-408-3623

Study Officials

• Lindell K. Weaver, MD

  Intermountain Health Care, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2011
• First Posted: September 8, 2011
• Study Start: July 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: February 15, 2013
• Results First Posted: February 7, 2013

Record last verified: 2012-12

Locations

US (2)