Measurement Of End-Tidal Carbon Dioxide Partial Pressure (PetCO2) Using A Portable Capnograph During Rest and Low-Loaded Steady State Work On An Ergometer: Test Of Reproducibility and Validation Against Standard Of Care Measurement During a Cardio Pulmonary Exercise Test.
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Reliability of PetCO2 sampling repeated over time.
研究概览
简要总结
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.
详细描述
Study summery The study is an experimental methodological investigation involving research participants who are essentially healthy. Individuals who consent to participate and meet all inclusion criteria without any exclusion criteria will be eligible for the study.
Each participant will perform a modified maximal exercise test on an ergometer on two separate occasions (1 to 4 weeks). The ergospirometric exercise test will be performed on a ergometer (eBike Basic, GE Medical Systems, GmbH), with PetCO₂ measured at rest while seated on the bike and at various predetermined steady state levels during low to moderate loading. Participants will then continue the protocol with a ramping workload to maximal exertion. The test will be terminated when the participant no longer can maintain the pedaling cadence (60 rpm) or develops predefined abnormal symptoms.
Gas analysis will be conducted using breath-by-breath technology (Jaeger Oxycon Pro or Vyntus CPX; Viasys Healthcare) and the hand held monitor (Capnostream35, Medtronic) connected to the nasal cannula.
Two test leaders (medically trained, one of whom is a physician) will oversee the exercise test, with one managing the ergospirometric equipment and the other handling PetCO₂ measurement via the handheld monitor.
Data from the handheld capnograph will be recorded on a specially coded (study ID) protocol form. Ergospirometric data including symptom ratings will be stored in a patient database under the participant's personal identity number.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged between 18 and 70 years.
- •Proficient in spoken and written Swedish.
- •Capable of cycling on an exercise bicycle.
排除标准
- •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
结局指标
主要结局
Reliability of PetCO2 sampling repeated over time.
时间窗: Up to 4 weeks
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?
次要结局
- 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)
研究者
Kristofer Hedman, MD, PhD
Senior Associate Professor
Linkoeping University
