Test of Chamber Pressure to Divers and Chamber Attendants: A Blinded Trial to Investigate if "Pressure-familiar" Individuals Can Determine Pressure
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.
Condition:
Traumatic Brain Injury
Treatment:
Hyperbaric Oxygen (1.5 atm abs)
Start Date:
July 2011
Sponsor:
Intermountain Health Care, Inc.
For More Information:
https://clinicaltrials.gov/show/NCT01430325