Hypercapnia: Cognitive Effects and Monitoring

NCT ID: NCT01782625

Last Updated: 2016-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2016-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypercapnia Exercise Nitrogen Narcosis Diving Immersion

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

dive to 122 feet, no exercise

Subjects will undergo a simulated dive to a maximum depth of 122 feet of seawater with no exercise at depth

Group Type EXPERIMENTAL

NO exercise at depth

Intervention Type OTHER

Subjects will NOT exercise while at depth

dive to 158 feet, no exercise

Subjects will undergo a simulated dive to a maximum depth of 154 feet of seawater with no exercise at depth

Group Type EXPERIMENTAL

NO exercise at depth

Intervention Type OTHER

Subjects will NOT exercise while at depth

dive to 122 feet, exercise

Subjects will undergo a simulated dive to a maximum depth of 122 feet of seawater with exercise at depth

Group Type EXPERIMENTAL

exercise at depth

Intervention Type OTHER

Subjects will exercise while at depth

dive to 158 feet, exercise

Subjects will undergo a simulated dive to a maximum depth of 154 feet of seawater with exercise at depth.

Group Type EXPERIMENTAL

exercise at depth

Intervention Type OTHER

Subjects will exercise while at depth

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

NO exercise at depth

Subjects will NOT exercise while at depth

Intervention Type OTHER

exercise at depth

Subjects will exercise while at depth

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Duke University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

John J Freiberger, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Duke Center for Hyperbaric Medicine and Environmental Physiology

Durham, North Carolina, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SPS 181258

Identifier Type: REGISTRY

Identifier Source: secondary_id

Pro00036937

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

NASA Prebreathe Study
NCT06740305 SUSPENDED PHASE1