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

Primary Purpose

Hypoxia, Hypercapnia, Cardiac Output, High

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Hypoxic
Hypercapnic
Hypoxic and Hypercapnic
Sponsored by
Czech Technical University in Prague
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hypoxia focused on measuring Cardiac Output, Perfusion index, Pulse oximetry

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Czech Technical University in Prague

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Hypoxic

Hypercapnic

Hypoxic and Hypercapnic

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Full Information

First Posted
June 25, 2022
Last Updated
June 29, 2022
Sponsor
Czech Technical University in Prague
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1. Study Identification

Unique Protocol Identification Number
NCT05441007
Brief Title
The Effect of Hypercapnia on Physiological Parameters During Short-term Breathing
Acronym
HYPERCO
Official Title
The Effect of Hypercapnia and Hypoxia on Physiological Parameters During Short-term Breathing Experiment
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 26, 2022 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Czech Technical University in Prague

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxia, Hypercapnia, Cardiac Output, High
Keywords
Cardiac Output, Perfusion index, Pulse oximetry

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Interventional single blinded randomized crossover prospective study. All participants go through all study arms, in random order.
Masking
Participant
Masking Description
The participant undergoes all three phases of the experiment and the participant does not know which one is it.
Allocation
Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hypoxic
Arm Type
Experimental
Arm Description
Participants inhale ambient air, the hypoxic gas mixture, and ambient air.
Arm Title
Hypercapnic
Arm Type
Experimental
Arm Description
Participants inhale ambient air, the hypercapnic gas mixture, and ambient air.
Arm Title
Hypoxic and Hypercapnic
Arm Type
Experimental
Arm Description
Participants inhale ambient air, the hypoxic and hypercapnic gas mixture, and ambient air.
Intervention Type
Other
Intervention Name(s)
Hypoxic
Intervention Description
Hypoxic gas mixture Gas mixture of 10% O2 and 90% N2 for six minutes.
Intervention Type
Other
Intervention Name(s)
Hypercapnic
Intervention Description
Hypercapnic gas mixture Gas mixture of 21% O2, 5% CO2 74% N2 for six minutes.
Intervention Type
Other
Intervention Name(s)
Hypoxic and Hypercapnic
Intervention Description
Hypoxic and Hypercapnic gas mixture Gas mixture of 10% O2, 5% CO2 85% N2 for six minutes.
Primary Outcome Measure Information:
Title
Changes in Cardiac output due to the induced hypoxia and hypercapnia
Description
Based on the induced hypoxia, hypercapnia or combination of hypoxia and hypercapnia, Cardiac output will change
Time Frame
1 hour
Title
Changes in Perfusion index due to the induced hypoxia and hypercapnia
Description
Based on the induced hypoxia, hypercapnia or combination of hypoxia and hypercapnia, Perfusion index will change
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Czech Technical University in Prague
City
Kladno
ZIP/Postal Code
27201
Country
Czechia

12. IPD Sharing Statement

Plan to Share IPD
No

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

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