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NCT05441007 Clinical Trial

The Effect of Hypercapnia on Physiological Parameters During Short-term Breathing

Hypoxia Clinical Trial

— HYPERCO  

Official title:
The Effect of Hypercapnia and Hypoxia on Physiological Parameters During Short-term Breathing Experiment

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05441007
Other study ID # CTU HYPERCO
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date June 26, 2022
Est. completion date June 30, 2024

Study information
Verified date June 2022
Source Czech Technical University in Prague
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 15
Est. completion date June 30, 2024
Est. primary completion date October 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Hypoxic
Hypoxic gas mixture Gas mixture of 10% O2 and 90% N2 for six minutes.
• Hypercapnic
Hypercapnic gas mixture Gas mixture of 21% O2, 5% CO2 74% N2 for six minutes.
• Hypoxic and Hypercapnic
Hypoxic and Hypercapnic gas mixture Gas mixture of 10% O2, 5% CO2 85% N2 for six minutes.

Locations
Country Name City State
Czechia Czech Technical University in Prague Kladno

Sponsors (1)
Lead Sponsor Collaborator
Czech Technical University in Prague

Country where clinical trial is conducted

Czechia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Changes in Cardiac output due to the induced hypoxia and hypercapnia Based on the induced hypoxia, hypercapnia or combination of hypoxia and hypercapnia, Cardiac output will change 1 hour
Primary Changes in Perfusion index due to the induced hypoxia and hypercapnia Based on the induced hypoxia, hypercapnia or combination of hypoxia and hypercapnia, Perfusion index will change 1 hour
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