NCT07816926尚未招募不适用
Evaluation of a Novel Portable Mainstream Capnograph MARIE in Adult Intubated Patients. A Prospective Validation Study
Malin Jonsson Fagerlund0 个研究点目标入组 30 人开始时间: 2026年9月7日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- To describe the Bland-Altman agreement of end-tidal CO₂ measurements between MARIE airway adapter (Oxlantic Medical AB) and a standard capnography, Getinge Flow-i, in intubated patients.
研究概览
简要总结
Primary endpoint: To describe the Bland-Altman agreement of end-tidal CO₂ (EtCO₂) measurements between MARIETM airway adapter (Oxlantic Medical AB) and a standard capnography, Getinge Flow-i, in intubated patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult, ≥18 years of age
- •Elective surgery under general anesthesia
- •Endotracheal intubation
- •Planned for arterial line
排除标准
- •Unable to understand study information or sign the consent form
研究组 & 干预措施
MARIE
Experimental
NOvel mainstream capnography
干预措施: MARIE (Device)
结局指标
主要结局
To describe the Bland-Altman agreement of end-tidal CO₂ measurements between MARIE airway adapter (Oxlantic Medical AB) and a standard capnography, Getinge Flow-i, in intubated patients.
时间窗: During anesthesia and mechanical ventilation
End-tidal carbon dioxide (EtCO2) will be measured by a standard capnograph from the company Getinge Flow-i and be compared to the end-tidal carbon dioxide of a novel portable mainstream capnograph MARIE
次要结局
- Correlation of end-tidal CO₂ (EtCO₂) measurements between MARIE and Getinge Flow-i(During anesthesia and mechanical ventilation maximum up to 12 hours after start of anesthesia)
- Correlation between PaCO₂ and EtCO₂ measured by MARIE and Getinge Flow-i, respectively.(During anesthesia and mechanical ventilation maximum up to 12 hours after start of anesthesia)
- Time trajectories of PaCO₂ and EtCO₂ measured using MARIE and Getinge Flow-i, respectively.(During anesthesia and mechanical ventilation maximum up to 12 hours after start of anesthesia)
- Overall agreement between EtCO₂ measured by MARIE, Getinge Flow-i, and PaCO₂.(During anesthesia and mechanical ventilation maximum up to 12 hours after start of anesthesia)
- Respiratory rate measured by MARIE compared to Getinge Flow-i.(During anesthesia and mechanical ventilation maximum up to 12 hours after start of anesthesia)
- Usability as reported by nurse.(During anesthesia and mechanical ventilation maximum up to 12 hours after start of anesthesia)
- Reasons for premature termination of MARIE.(During anesthesia and mechanical ventilation maximum up to 12 hours after start of anesthesia)
- Registration of technical problems, e.g. unexpected shutdowns or blockage by mucus.(During anesthesia and mechanical ventilation maximum up to 12 hours after start of anesthesia)
研究者
Malin Jonsson Fagerlund
Professor
Karolinska University Hospital
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