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

Sponsor

Czech Technical University in Prague (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05441007

Collaborator

(none)

Enrollment

Location

Arms

24.1

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hypoxia Hypercapnia Cardiac Output, High	Other: Hypoxic Other: Hypercapnic Other: Hypoxic and Hypercapnic	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

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

Masking:

Single (Participant)

Masking Description:

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

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Jun 26, 2022

Anticipated Primary Completion Date :

Oct 30, 2023

Anticipated Study Completion Date :

Jun 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Hypoxic Participants inhale ambient air, the hypoxic gas mixture, and ambient air.	Other: Hypoxic Hypoxic gas mixture Gas mixture of 10% O2 and 90% N2 for six minutes.
Experimental: Hypercapnic Participants inhale ambient air, the hypercapnic gas mixture, and ambient air.	Other: Hypercapnic Hypercapnic gas mixture Gas mixture of 21% O2, 5% CO2 74% N2 for six minutes.
Experimental: Hypoxic and Hypercapnic Participants inhale ambient air, the hypoxic and hypercapnic gas mixture, and ambient air.	Other: Hypoxic and Hypercapnic Hypoxic and Hypercapnic gas mixture Gas mixture of 10% O2, 5% CO2 85% N2 for six minutes.

Arm

Intervention/Treatment

Experimental: Hypoxic

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

Other: Hypoxic

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

Experimental: Hypercapnic

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

Other: Hypercapnic

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

Experimental: Hypoxic and Hypercapnic

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

Other: Hypoxic and Hypercapnic

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

Outcome Measures

Primary Outcome Measures

Changes in Cardiac output due to the induced hypoxia and hypercapnia [1 hour]
Based on the induced hypoxia, hypercapnia or combination of hypoxia and hypercapnia, Cardiac output will change
Changes in Perfusion index due to the induced hypoxia and hypercapnia [1 hour]
Based on the induced hypoxia, hypercapnia or combination of hypoxia and hypercapnia, Perfusion index will change

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Czech Technical University in Prague	Kladno		Czechia	27201

Sponsors and Collaborators

Czech Technical University in Prague

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Czech Technical University in Prague

ClinicalTrials.gov Identifier:

NCT05441007

Other Study ID Numbers:

CTU HYPERCO

First Posted:

Jul 1, 2022

Last Update Posted:

Jul 1, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Czech Technical University in Prague

Cardiac Output

Perfusion index

Pulse oximetry

Additional relevant MeSH terms:

Cardiac Output, High

Hypoxia

Hypercapnia

Study Results

No Results Posted as of Jul 1, 2022