HypoxiaHYPERCONCT05441007
The Effect of Hypercapnia on Physiological Parameters During Short-term Breathing
A study testing Hypoxic, Hypercapnic and Hypoxic and Hypercapnic in people with Hypoxia and Hypercapnia, run by Czech Technical University in Prague at 1 site in Czechia.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypoxia, Hypercapnia, Cardiac Output, High
- What is being tested?
- Hypoxic, Hypercapnic and Hypoxic and Hypercapnic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCzechia
- Study dates
- 22 Jun 2022to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Hypercapnia and Hypoxia on Physiological Parameters During Short-term Breathing Experiment
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.
Read the 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.
- Conditions
- Hypoxia, Hypercapnia, Cardiac Output, High
- Being tested
- Hypoxic, Hypercapnic, Hypoxic and Hypercapnic
- Keywords
- Cardiac Output, Perfusion index, Pulse oximetry
- Medical subject headings
- Hypoxia, Hypercapnia, Cardiac Output, High
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypoxicOther
Hypoxic gas mixture Gas mixture of 10% O2 and 90% N2 for six minutes.
HypercapnicOther
Hypercapnic gas mixture Gas mixture of 21% O2, 5% CO2 74% N2 for six minutes.
Hypoxic and HypercapnicOther
Hypoxic and Hypercapnic gas mixture Gas mixture of 10% O2, 5% CO2 85% N2 for six minutes.
| Study group | Role | What they receive |
|---|---|---|
| Hypoxic | Experimental | Participants inhale ambient air, the hypoxic gas mixture, and ambient air. Receives: Other: Hypoxic |
| Hypercapnic | Experimental | Participants inhale ambient air, the hypercapnic gas mixture, and ambient air. Receives: Other: Hypercapnic |
| Hypoxic and Hypercapnic | Experimental | Participants inhale ambient air, the hypoxic and hypercapnic gas mixture, and ambient air. Receives: Other: Hypoxic and Hypercapnic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2022
- Study start22 Jun 2022
- Primary completion30 Mar 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Interventional single blinded randomized crossover prospective study. All participants go through all study arms, in random order.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Czech Technical University in Prague
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karel Roubik, Professor, Principal investigator, Czech Technical University in Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05441007
- Sponsor's protocol ID
- CTU HYPERCO
- Acronym
- HYPERCO
- Status last verified
- Mar 2026
- First submitted
- 25 Jun 2022
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hypercapnia and Hypoxia on Physiological Parameters During Short-term Breathing Experiment
- ClinicalTrials.gov ID
- NCT05441007
- Acronym / sponsor ID
- HYPERCO / CTU HYPERCO
- Conditions
- Hypoxia, Hypercapnia, Cardiac Output, High
- Keywords
- Cardiac Output, Perfusion index, Pulse oximetry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Czech Technical University in PragueUniversity, hospital or other
- Study start
- 22 Jun 2022 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 1 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Interventional single blinded randomized crossover prospective study. All participants go through all study arms, in random order.
| Arm | Type | Receives |
|---|---|---|
| Hypoxic | Experimental | Other: HypoxicParticipants inhale ambient air, the hypoxic gas mixture, and ambient air. |
| Hypercapnic | Experimental | Other: HypercapnicParticipants inhale ambient air, the hypercapnic gas mixture, and ambient air. |
| Hypoxic and Hypercapnic | Experimental | Other: Hypoxic and HypercapnicParticipants inhale ambient air, the hypoxic and hypercapnic gas mixture, and ambient air. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy volunteers
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HypoxicHypoxic gas mixture Gas mixture of 10% O2 and 90% N2 for six minutes. | Other | Hypoxic |
| HypercapnicHypercapnic gas mixture Gas mixture of 21% O2, 5% CO2 74% N2 for six minutes. | Other | Hypercapnic |
| Hypoxic and HypercapnicHypoxic and Hypercapnic gas mixture Gas mixture of 10% O2, 5% CO2 85% N2 for six minutes. | Other | Hypoxic and Hypercapnic |
Primary outcome
Changes in Cardiac output due to the induced hypoxia and hypercapnia
Time frame: 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
Time frame: 1 hour
Based on the induced hypoxia, hypercapnia or combination of hypoxia and hypercapnia, Perfusion index will change
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Hypoxia
Not yet recruitingEarly Phase 1
Multiparametric Metabolic and Hypoxic PET/MRI Imaging Substudy in Gliomas
Glioma
Not yet recruiting
Impact of Closed PBSC Collection With Reduced Gas-Phase Oxygen Exposure on Graft Quality and Early Engraftment in Allo-HSCT
Allogeneic Hematopoietic Stem Cell Transplantation (HSCT), Oxygen Deficiency
RecruitingObservational study
Predict Severe Traumatic Brain Injury
Traumatic Brain Injury
Recruiting
Sustained Cord Circulation at Emergency Cesarean Section
Asphyxia Neonatorum, Fetal Hypoxia
Not yet recruiting
Effect of High-flow Nasal Cannula Oxygenation on the Incidence of Hypoxemia During Painless Gastrointestinal Endoscopy in Patients at High Risk for Obstructive Sleep Apnea Syndrome in High-altitude Regions
Hypoxemia, Gastric Cancer (Diagnosis)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karel Roubik, Professor principal investigator
Czech Technical University in Prague
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypoxic, Hypercapnic and Hypoxic and Hypercapnic in people with Hypoxia and Hypercapnia, run by Czech Technical University in Prague at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Cardiac output due to the induced hypoxia and hypercapnia (time frame: 1 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.