Status:

COMPLETED

Test of Chamber Pressure to Divers and Chamber Attendants

Lead Sponsor:

Intermountain Health Care, Inc.

Conditions:

Traumatic Brain Injury

Eligibility:

All Genders

18-65 years

Phase:

NA

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.

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,...

Eligibility Criteria

Inclusion

  • 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

Exclusion

  • 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

Key Trial Info

Start Date :

July 1 2011

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 1 2011

Estimated Enrollment :

42 Patients enrolled

Trial Details

Trial ID

NCT01430325

Start Date

July 1 2011

End Date

October 1 2011

Last Update

February 15 2013

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Intermountain Medical Center

Murray, Utah, United States, 84107

2

LDS Hospital

Salt Lake City, Utah, United States, 84143