Test-Retest Reliability And Validation For End-Tidal Carbon Dioxide Measurement (PetCO2) During Rest And Low-Loaded Steady State Work Using A Portable Capnograph.

NCT07326449 | Enrolling By Invitation

• 1 other identifier: 2025-01777-01
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to investigate exhaled carbon dioxide measuring during rest and low-loaded work using a portable device (capnograph) and standard of care apparatus during a cardiopulmonary exercise test (CPET) in healthy volunteers. The study aims to answer: How reliable is exhaled end-tidal carbon dioxide measurement for an individual over time using both standard of care apparatus and a portable device during an ergometer test? Do the measurements correlate between the portable device and standard of care apparatus? How do changes in breathing instructions and placement of sampling cannula affect the measurements from the portable device (capnograph)? How is the reliability over time of other well established values from a cardio pulmonary exercise test? Participants will be asked to perform a modified cardiopulmonary exercise test on an ergometer twice, separated in time (1-4 weeks). Measurements are sampled alternating standard of care apparatus and a portable capnograph at rest and during low-loaded work.

Conditions

End-Tidal Carbon Dioxide; VO2max; Ventilatory Physiology; Cardiopulmonary Exercise Test

Keywords

End-tidal carbon dioxide measurement; Ventilatory efficiency; Cardiopulmonary exercise test

Outcome Measures

Primary Outcomes (1)

• Reliability of PetCO2 sampling repeated over time.

  Intra-class correlation coefficient and covariance for repeated measurements with the handheld capnopragh and ergospiromtry at the same workload over time. What is the reliability of PetCO₂ measurement in the same individual, using a handheld PetCO₂ monitor with mask/nasal cannula compared to a closed respiratory gas analysis system (ergospirometry), during repeated measurements on two different days, at rest and at various levels of exertion during a cycle ergometer test?

  Up to 4 weeks

Secondary Outcomes (3)

• Correlation of PetCO2 measurements between standard of care ergospirometry and handheld PetCO2 monitor

  Up to 4 weeks

• Correlation measured as agreement for different sampling methods on the handheld capnograph.

  Up to 4 weeks

• Intraclass correlation coefficient and covariance for other established ergospirometric variables (VO2peak, VE/VCO2slope)

  Up to 4 weeks

Study Arms (1)

Cohort 1 - Healthy volunteers

Cohort 1 consists of 20 study participants eligable with the inclusion and exclusion criteria.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteer research participants recruited through advertisements at the research group's workplaces.

You may qualify if:

• Adults aged between 18 and 70 years.
• Proficient in spoken and written Swedish.
• Capable of cycling on an exercise bicycle.

You may not qualify if:

• Current symptoms of upper respiratory tract infection or fever within the past 5 days
• Obesity (BMI \> 30 kg/m²)
• Known respiratory pattern disorders/hyperventilation syndrome
• More than mild asthma or other pulmonary diseases
• Cardiovascular disease (except for hypertension with or without treatment, mild heart valve disease at most, previous pericarditis \> 12 months prior)
• Known pregnancy
• Presence of exertion-related symptoms such as chest pain, dizziness, syncope, arrhythmia, or abnormal shortness of breath

Sponsors & Collaborators

• Linkoeping University: lead

Study Sites (1)

Region Östergötland

Linköping, Sweden

Location

Study Officials

• Kristofer Hedman, PhD. Associate professor

  Linkoeping University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Associate Professor

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: January 8, 2026
• Study Start: June 6, 2025
• Primary Completion: January 19, 2026
• Study Completion: February 1, 2026
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)