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Hypercapnia: Cognitive Effects and Monitoring

Hypercapnia: Cognitive Effects and Monitoring

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01782625
Enrollment
58
Registered
2013-02-04
Start date
2013-01-31
Completion date
2016-02-29
Last updated
2016-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diving, Exercise, Hypercapnia, Immersion, Nitrogen Narcosis

Keywords

diving, cognitive impairment, nitrogen narcosis, narcosis, end tidal carbon dioxide, arterial carbon dioxide, immersion

Brief summary

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).

Interventions

OTHERNO exercise at depth

Subjects will NOT exercise while at depth

OTHERexercise at depth

Subjects will exercise while at depth

Sponsors

Duke University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Is cognitive ability different while resting versus compared to cognitive ability while diving, breathing different gas mixtures and while exercising?pre-dive to dive to post-dive (approximately 2 hours)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.

Secondary

MeasureTime frameDescription
How does exhaled (end tidal) carbon dioxide compare with arterial carbon dioxide?pre-dive to dive to post dive (approximately 2 hours)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)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026