Exercise Clinical Trial
Official title:
Hypercapnia: Cognitive Effects and Monitoring
Verified date | May 2016 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
The investigators will simulate the conditions of a working, helmeted diver by using
exercising, "head out" immersed subjects to test the following hypotheses:
1. An algorithm can be developed which predicts cognitive performance in immersed
exercising divers, based on the exhaled carbon dioxide (PETCO2) and the diver's
inspired partial pressures of oxygen and nitrogen (PIO2 and PIN2).
2. PETCO2 using mass spectrometry is an accurate estimate of arterial carbon dioxide
(PaCO2) at rest and during immersed exercise and can be used as a PaCO2 surrogate at
levels exceeding 50 mmHg and depths up to 158 fsw (gas density 6.4 g/l, similar to 165
fsw density of 6.8 g/l).
Status | Completed |
Enrollment | 58 |
Est. completion date | February 2016 |
Est. primary completion date | February 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: - healthy, - male, - age greater than 18, - age less than 50 Exclusion Criteria: - smoker, - asthma, - cardiac disease, - inability to pedal a bicycle ergometer, - inability to perform vigorous exercise |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
United States | Duke Center for Hyperbaric Medicine and Environmental Physiology | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Duke University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Is cognitive ability different while resting versus compared to cognitive ability while diving, breathing different gas mixtures and while exercising? | Subjects will undergo computerized cognitive testing before, during and after a simulated dive in the Duke Hyperbaric Chamber. Different exercise conditions (rest or exercise) and different breathing gas mixtures (added carbon dioxide or not)will be assessed and compared to the pre-dive conditions. | pre-dive to dive to post-dive (approximately 2 hours) | No |
Secondary | How does exhaled (end tidal) carbon dioxide compare with arterial carbon dioxide? | Exhaled (end tidal) carbon dioxide will be compared to arterial carbon dioxide at the various experimental conditions of the study (at the surface versus during the dive, during exercise versus during rest, breathing gas with added carbon dioxide versus breathing gas without added carbon dioxide) | pre-dive to dive to post dive (approximately 2 hours) | No |
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