- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05441007
The Effect of Hypercapnia on Physiological Parameters During Short-term Breathing (HYPERCO)
March 10, 2026 updated by: Czech Technical University in Prague
The Effect of Hypercapnia and Hypoxia on Physiological Parameters During Short-term Breathing Experiment
The aim of the project is to evaluate the effect of hypercapnia on physiological parameters in a healthy person during short-term hypoxia and hypercapnia.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Hypercapnia causes changes in physiological parameters at various levels throughout the body.
The study aims to evaluate the effect of hypercapnia on physiological parameters in a healthy person during short-term hypoxia and hypercapnia.
It is an intervention prospective study that will be conducted at the Faculty of Biomedical Engineering on healthy volunteers.
All the volunteers undergo three different phases in random order.
The individual phases differ in the breathed mixture of oxygen, nitrogen and carbon dioxide gases.
Non-invasive measurements of physiological parameters, especially blood oxygen saturation, perfusion index and cardiac output, will be performed continuously during the experiment.
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Kladno, Czechia, 27201
- Czech Technical University in Prague
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Healthy volunteers
Exclusion Criteria:
- pregnancy
- severe cardiovascular conditions
- severe asthma or other severe respiratory conditions
- injury to the upper limbs or hands that could affect the peripheral perfusion
- diabetes
- hypotension or hypertension
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Hypoxic
Participants inhale ambient air, the hypoxic gas mixture, and ambient air.
|
Hypoxic gas mixture Gas mixture of 10% O2 and 90% N2 for six minutes.
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|
Experimental: Hypercapnic
Participants inhale ambient air, the hypercapnic gas mixture, and ambient air.
|
Hypercapnic gas mixture Gas mixture of 21% O2, 5% CO2 74% N2 for six minutes.
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|
Experimental: Hypoxic and Hypercapnic
Participants inhale ambient air, the hypoxic and hypercapnic gas mixture, and ambient air.
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Hypoxic and Hypercapnic gas mixture Gas mixture of 10% O2, 5% CO2 85% N2 for six minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in Cardiac output due to the induced hypoxia and hypercapnia
Time Frame: 1 hour
|
Based on the induced hypoxia, hypercapnia or combination of hypoxia and hypercapnia, Cardiac output will change
|
1 hour
|
|
Changes in Perfusion index due to the induced hypoxia and hypercapnia
Time Frame: 1 hour
|
Based on the induced hypoxia, hypercapnia or combination of hypoxia and hypercapnia, Perfusion index will change
|
1 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Karel Roubik, Professor, Czech Technical University in Prague
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 22, 2022
Primary Completion (Actual)
March 30, 2024
Study Completion (Actual)
June 30, 2024
Study Registration Dates
First Submitted
June 25, 2022
First Submitted That Met QC Criteria
June 29, 2022
First Posted (Actual)
July 1, 2022
Study Record Updates
Last Update Posted (Actual)
March 11, 2026
Last Update Submitted That Met QC Criteria
March 10, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CTU HYPERCO
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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