Evaluation of a Novel Portable Mainstream Capnograph MARIE in Adult Postoperative Patients - A Prospective Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The primary endpoint is correlation of end-tidal CO₂ (EtCO₂) measurements between MARIETM (Oxlantics Medical) and Philips Intelli Vue X3 Microstream
研究概览
简要总结
Postoperative respiratory complications are common and sometimes hard to detect early. Desaturation is a late sign of reduced minute ventilation, especially if the patient is on supplemental oxygen, and measurement of arterial or endtidal CO2 will rapidly detect a reduction in minute ventilation. Capnography offers a non-invasive and continuous measure of end-tidal expiratory pressure of carbon dioxide (EtCO2). Capnography is not a standard in postoperative care but rather quite rare. In the present study we evaluate a novel portable capnography device, MARIE, in postoperative patients.
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The primary outcome is to describe the correlation of end-tidal CO₂ (EtCO₂) measurements between MARIETM (Oxlantics Medical) and Philips Intelli Vue X3 Microstream.
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Secondary outcomes include
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Correlation between PaCO₂ and EtCO₂ measured by MARIE and Philips Intelli Vue X3 Microstream, respectively.
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Time trajectories of PaCO₂ and EtCO₂ measured using MARIE and Philips Intelli Vue X3 Microstream, respectively
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The overall agreement between the EtCO2 measured by MARIE and Philips Intelli Vue X3 Microstream and PaCO2
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Respiratory rate measured by MARIE compared to manual counting and Philips Intelli Vue X3.
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Comparison of oxygen flow by MARIE and the rotameter.
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Comfort as reported by patient.
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Usability as reported by nurse.
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Reasons for premature termination of MARIE
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Registration of technical problems, for example unexpected shut downs and blockage by mucus.
MARIE will be applied immediately after tracheal extubation after surgery. CO2 values from MARIE will be compared to EtCO2 and PaCO2 derived from capnography equipment routinely used in the hospital and blood gas analysis, at set intervals in the postoperative ward. Respiratory rate will be compared to our standard care monitors, ie Philips Intelli Vue X3, alongside manual counting. Rate of oxygen delivery, when applicable, will also be compared to the rotameter.
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
- •Planned for over night postoperative care
排除标准
- •Tracheostomy
- •Nasal obstruction
- •Rhino- or oral surgery
- •Not able to understand study information or signing consent form
结局指标
主要结局
The primary endpoint is correlation of end-tidal CO₂ (EtCO₂) measurements between MARIETM (Oxlantics Medical) and Philips Intelli Vue X3 Microstream
时间窗: From enrolment to discharge from the postoperative unit or maximum 24 hours
End-tidal CO₂ (EtCO₂) measurements will be measured by MARIE (Oxlantic Medical AB) and Philips Intelli Vue X3 Microstream at several occasions and thereafter correlated
次要结局
- Reasons for premature termination of MARIE(From the enrolment to the discharge from the postoperative unit or a maximum of 24 hours)
- Correlation between PaCO₂ and EtCO₂ measured by MARIE and Philips Intelli Vue X3 Microstream, respectively.(From enrolment in the study until discharge from the postoperative unit or maximum 24 hours)
- Time trajectories of PaCO₂ and EtCO₂ measured using MARIE and Philips Intelli Vue X3 Microstream, respectively(From enrolment until discharge from the postoperative unit or maximum of 24 hours)
- The overall agreement between the EtCO2 measured by MARIE and Philips Intelli Vue X3 Microstream and PaCO2(From enrolment until discharge from the postoperative unit or a maximum of 24 hours)
- Respiratory rate measured by MARIE compared to manual counting and Philips Intelli Vue X3(From the enrolment in the study and until discharge from the postoperative unit or a maximum of 24 hours)
- Comparison of oxygen flow by MARIE and the rotameter(From enrolment in the study until discharge from the postoperative unit or a maximum of 24 hours)
- Comfort as reported by patient as VAS (0-10).(Three times/24 hours from admission to the postoperative unit until discharge from the postoperative unit or maximum 24 hours)
- Usability as reported by nurse as VAS (0-10).(From the time of enrolment until discharge from the postoperative unit of maximum 24 hours)
研究者
Malin Jonsson Fagerlund
Professor
Karolinska University Hospital