NCT01430325

Test of Chamber Pressure to Divers and Chamber Attendants

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Intermountain Health Care, Inc. · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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, 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

Interventions

Type	Name	Description
DRUG	Hyperbaric Oxygen (1.5 atm abs)	Hyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs.
DRUG	Sham Chamber Session	Sham control chamber session: regular air delivered at a chamber pressure of 1.2 atm abs

Timeline

• Start date: 2011-07-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2011-09-08
• Last updated: 2013-02-15
• Results posted: 2013-02-07

Locations

2 sites across 1 country: United States