NCT05441007

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 22, 2022

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

June 25, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 1, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

March 11, 2026

Status Verified

March 1, 2026

Enrollment Period

1.8 years

First QC Date

June 25, 2022

Last Update Submit

March 10, 2026

Conditions

Keywords

Cardiac OutputPerfusion indexPulse oximetry

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (3)

Hypoxic

EXPERIMENTAL

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

Other: Hypoxic

Hypercapnic

EXPERIMENTAL

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

Other: Hypercapnic

Hypoxic and Hypercapnic

EXPERIMENTAL

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

Other: Hypoxic and Hypercapnic

Interventions

HypoxicOTHER

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

Hypoxic

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

Hypercapnic

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

Hypoxic and Hypercapnic

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy volunteers

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Czech Technical University in Prague

Kladno, 27201, Czechia

Location

MeSH Terms

Conditions

HypoxiaHypercapniaCardiac Output, High

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsHeart DiseasesCardiovascular Diseases

Study Officials

  • Karel Roubik, Professor

    Czech Technical University in Prague

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The participant undergoes all three phases of the experiment and the participant does not know which one is it.
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Interventional single blinded randomized crossover prospective study. All participants go through all study arms, in random order.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2022

First Posted

July 1, 2022

Study Start

June 22, 2022

Primary Completion

March 30, 2024

Study Completion

June 30, 2024

Last Updated

March 11, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations