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临床试验/NCT07834411
NCT07834411已完成不适用

Correlation of End-Tidal Carbon Dioxide Values Measured by Different Capnographic Devices With Blood Gas Analysis in Patients Presenting to Emergency Department: A Prospective Non-Randomized Study

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey1 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2024年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
135
试验地点
1
主要终点
Agreement Between PaCO₂ and EtCO₂ Measurements Obtained Using Mainstream, Sidestream, and Microstream Capnography

研究概览

简要总结

Capnography provides continuous, non-invasive assessment of ventilation by measuring end-tidal carbon dioxide (EtCO₂). Different capnographic technologies, including mainstream, sidestream, and microstream capnography, may produce different EtCO₂ measurements depending on their sampling and measurement techniques.

This prospective, non-randomized observational study was designed to compare EtCO₂ values obtained using mainstream, sidestream, and microstream capnography with carbon dioxide partial pressure (PCO₂) values obtained from clinically indicated blood gas analysis in adult patients presenting to the emergency department.

For each participant, EtCO₂ measurements were obtained using the three capnographic methods in close temporal proximity to blood gas sampling. The relationship and agreement between blood gas PCO₂ and EtCO₂ measurements were planned to be evaluated using correlation analyses and Bland-Altman analysis. Additional analyses were planned according to whether the blood gas sample was arterial or venous.

详细描述

This prospective, non-randomized, cross-sectional observational study was conducted in the Emergency Department of the University of Health Sciences Sultan II. Abdülhamid Han Training and Research Hospital.

The study population consisted of adult patients presenting to the emergency department for whom blood gas analysis was requested by the treating physician as part of routine clinical care.

The primary objective of the study was to evaluate the agreement between blood gas PCO₂ measurements and end-tidal carbon dioxide (EtCO₂) values obtained using three different capnographic technologies: mainstream, sidestream, and microstream capnography.

A secondary objective was to compare the agreement of each capnographic method with blood gas PCO₂ measurements and to evaluate whether the relationship differed according to the type of blood gas sample, arterial or venous.

Eligible participants were adults aged 18 years or older whose level of consciousness and clinical condition were suitable for EtCO₂ measurement and who provided informed consent. Exclusion criteria included age younger than 18 years, pregnancy, refusal or inability to provide informed consent, Glasgow Coma Scale score below 15, and clinical or anatomical conditions preventing appropriate capnographic measurement. Patients with sepsis, diabetic ketoacidosis, hypovolemic shock, acute major bleeding, or severe dehydration were also excluded because these conditions could potentially affect the relationship between EtCO₂ and blood gas PCO₂.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 years or older. Presentation to the emergency department with a clinical indication for blood gas analysis as determined by the treating physician.
  • Level of consciousness and clinical condition suitable for end-tidal carbon dioxide (EtCO₂) measurement.
  • Ability and willingness to provide informed consent for participation in the study.

排除标准

  • Age younger than 18 years. Refusal or inability to provide informed consent. Pregnancy. Glasgow Coma Scale score below
  • Any anatomical deformity or condition preventing appropriate capnography measurement.
  • Sepsis. Diabetic ketoacidosis. Hypovolemic shock. Acute major bleeding. Severe dehydration.

研究组 & 干预措施

Venous Blood Gas Cohort

Adult patients presenting to the emergency department who underwent clinically indicated venous blood gas analysis. In each participant, end-tidal carbon dioxide (etCO₂) was measured using mainstream, sidestream, and microstream capnography simultaneously or in close temporal proximity to blood gas sampling. Capnographic etCO₂ measurements were compared with venous blood gas PCO₂ values. No randomization was performed, and all three capnographic methods were applied to each participant.

干预措施: Sidestream Capnography (Diagnostic Test)

Venous Blood Gas Cohort

Adult patients presenting to the emergency department who underwent clinically indicated venous blood gas analysis. In each participant, end-tidal carbon dioxide (etCO₂) was measured using mainstream, sidestream, and microstream capnography simultaneously or in close temporal proximity to blood gas sampling. Capnographic etCO₂ measurements were compared with venous blood gas PCO₂ values. No randomization was performed, and all three capnographic methods were applied to each participant.

干预措施: Microstream Capnography (Diagnostic Test)

Arterial Blood Gas Cohort

Adult patients presenting to the emergency department who underwent clinically indicated arterial blood gas analysis. In each participant, end-tidal carbon dioxide (etCO₂) was measured using mainstream, sidestream, and microstream capnography simultaneously or in close temporal proximity to blood gas sampling. Capnographic etCO₂ measurements were compared with arterial PaCO₂ values. No randomization was performed, and all three capnographic methods were applied to each participant.

干预措施: Mainstream Capnography (Diagnostic Test)

Arterial Blood Gas Cohort

Adult patients presenting to the emergency department who underwent clinically indicated arterial blood gas analysis. In each participant, end-tidal carbon dioxide (etCO₂) was measured using mainstream, sidestream, and microstream capnography simultaneously or in close temporal proximity to blood gas sampling. Capnographic etCO₂ measurements were compared with arterial PaCO₂ values. No randomization was performed, and all three capnographic methods were applied to each participant.

干预措施: Sidestream Capnography (Diagnostic Test)

Arterial Blood Gas Cohort

Adult patients presenting to the emergency department who underwent clinically indicated arterial blood gas analysis. In each participant, end-tidal carbon dioxide (etCO₂) was measured using mainstream, sidestream, and microstream capnography simultaneously or in close temporal proximity to blood gas sampling. Capnographic etCO₂ measurements were compared with arterial PaCO₂ values. No randomization was performed, and all three capnographic methods were applied to each participant.

干预措施: Microstream Capnography (Diagnostic Test)

Venous Blood Gas Cohort

Adult patients presenting to the emergency department who underwent clinically indicated venous blood gas analysis. In each participant, end-tidal carbon dioxide (etCO₂) was measured using mainstream, sidestream, and microstream capnography simultaneously or in close temporal proximity to blood gas sampling. Capnographic etCO₂ measurements were compared with venous blood gas PCO₂ values. No randomization was performed, and all three capnographic methods were applied to each participant.

干预措施: Mainstream Capnography (Diagnostic Test)

结局指标

主要结局

Agreement Between PaCO₂ and EtCO₂ Measurements Obtained Using Mainstream, Sidestream, and Microstream Capnography

时间窗: Within 1 day of emergency department assessment

Agreement between blood gas PaCO₂ and end-tidal carbon dioxide (EtCO₂) measurements obtained using mainstream, sidestream, and microstream capnography. Agreement was assessed using Bland-Altman analysis by calculating the mean difference (bias) and 95% limits of agreement for each capnography method compared with blood gas PaCO₂.

次要结局

未报告次要终点

研究者

发起方
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
申办方类型
Other
责任方
Principal Investigator
主要研究者

Erdem Cevik

Professor of Emergency Medicine

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

研究点 (1)

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