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

NCT ID: NCT05441007

Last Updated: 2022-07-01

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

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-26

Study Completion Date

2024-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hypoxia Hypercapnia Cardiac Output, High

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Interventional single blinded randomized crossover prospective study. All participants go through all study arms, in random order.
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants
The participant undergoes all three phases of the experiment and the participant does not know which one is it.

Study Groups

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Hypoxic

Participants inhale ambient air, the hypoxic gas mixture, and ambient air.

Group Type EXPERIMENTAL

Hypoxic

Intervention Type OTHER

Hypoxic gas mixture Gas mixture of 10% O2 and 90% N2 for six minutes.

Hypercapnic

Participants inhale ambient air, the hypercapnic gas mixture, and ambient air.

Group Type EXPERIMENTAL

Hypercapnic

Intervention Type OTHER

Hypercapnic gas mixture Gas mixture of 21% O2, 5% CO2 74% N2 for six minutes.

Hypoxic and Hypercapnic

Participants inhale ambient air, the hypoxic and hypercapnic gas mixture, and ambient air.

Group Type EXPERIMENTAL

Hypoxic and Hypercapnic

Intervention Type OTHER

Hypoxic and Hypercapnic gas mixture Gas mixture of 10% O2, 5% CO2 85% N2 for six minutes.

Interventions

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Hypoxic

Hypoxic gas mixture Gas mixture of 10% O2 and 90% N2 for six minutes.

Intervention Type OTHER

Hypercapnic

Hypercapnic gas mixture Gas mixture of 21% O2, 5% CO2 74% N2 for six minutes.

Intervention Type OTHER

Hypoxic and Hypercapnic

Hypoxic and Hypercapnic gas mixture Gas mixture of 10% O2, 5% CO2 85% N2 for six minutes.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Czech Technical University in Prague

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Czech Technical University in Prague

Kladno, , Czechia

Site Status

Countries

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Czechia

Other Identifiers

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CTU HYPERCO

Identifier Type: -

Identifier Source: org_study_id

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