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Test of Chamber Pressure to Divers and Chamber Attendants — TOP-DIVER  

Traumatic Brain Injury Clinical Trial

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

Clinical 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01430325
Study type Interventional
Source Intermountain Health Care, Inc.
Contact
Status Completed
Phase N/A
Start date July 2011
Completion date October 2011
View Details
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