N/A Completed N=42 Randomized Triple-blind

Test of Chamber Pressure to Divers and Chamber Attendants

Traumatic Brain Injury

Source: ClinicalTrials.gov NCT01430325 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2013

Primary outcomePrimary: Participants Indicating "I do Not Know" on Depth Questionnaire. — 7; 4; 4; 4 participants

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Participants Indicating "I do Not Know" on Depth Questionnaire.	7; 4; 4; 4	—
PRIMARY Participant Perception of Depth	65; 35; 23; 23	—
PRIMARY Participant Perception of Breathing Gas	80; 91; 88; 67	—

Eligibility Criteria

Inclusion Criteria

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 Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01430325). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.