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临床试验/NCT04735380
NCT04735380已完成不适用

Agreements Between Transcutaneous and Arterial Monitoring of Oxygen and Carbon Dioxide After Non-cardiac Surgery

Rigshospitalet, Denmark1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
1
主要终点
TCM changes

研究概览

简要总结

The primary aim of the study is to describe the association between changes in TcO2 and TcCO2 and interventions such as blood transfusion, fluid therapy, respiratory support, use of vasopressors, analgesics, and adverse events during PACU admission. The secondary aim is to describe the agreement between TcPO2 and TcPCO2 and PaO2 and PaCO2 in patients after non-cardiac surgery.

详细描述

Study method The data collection will start 1st of February 2021 and will be finished by 30th of April 2021. Patients will be set up with TCM equipment and an Empatica at the PACU. They will be observed for 2 hours. If an intervention is started before 2 hours and not completed, recordings will continue until 5 minutes after the intervention is completed for a maximum of 1 hour (3 hours maximal observation). The sensor will be placed on the patient's antebrachium. Patients will be set up with TCM equipment as soon as possible after arrival at PACU. Every clinical procedure entailing changes in circulatory and/or respiratory support or medication (appendix 1) will be observed and noted in a timetable (ap-pendix 2). Perfusion index (PI) and a full DASAIM score (Danish Association of Anesthesiology and Intensive Care Medicine) will be noted every 15 minutes. Every ABG analysis of PaO2, PaCO2 and lactate conducted during the observational period will be noted.

Age, sex, BMI (Body Mass Index), ASA-score (American Society of Anesthesiologists physical sta-tus classification), comorbidity (Charlson Comorbidity Index - CCI), baseline laboratory data (hemo-globin and creatinine) and name of surgical procedure will be obtained for each patient. REDCap (Research Electronic Data Capture) will be used as a data management system for the project. The study is a part of the Wireless Assessment of Respiratory and circulatory Distress (WARD) project.

Study materials All patients will be monitored with a TCM-5 Flex monitor connected to a Sensor 84 (Radiometer Medical Aps, Brønshøj, Denmark). The sensor consists of a Stow-Severinghaus-type TcPCO2 electrode combined with a Clark-type TcPO2 electrode, with values per second for TcPO2, TcPCO2 in kPa and heat effect measured in units of mW. The sensor temperature will automatically be heated to 43.5℃ and calibrated. The sensor membrane will be changed every 28th day. There will be a 20-minute stabilization period from patient setup to valid data capturing. The use of sensors and monitors will be according to the manufacturer's instructions.

As a supplement, patients will be wearing an Empatica, as a measurement for the activity of the autonomic nervous system. The Empatica tracks activity, heartrate, blood volume pulse, skin temper-ature and skin conductance. The Empatica E4 consist of a PPG sensor and an EDA sensor. Data from the E4 will be processed in further studies and is not a part of the statistical analysis in this protocol.

Statistics The primary analysis is changes in TCM readings, and the association between clinical procedures, tested using paired statistics comparing both average (mean) TcPO2 and TcPCO2 during 5 minutes before an intervention versus 5 minutes after an intervention. Depending on the data distribution, either t-test or Wilcoxon test will be used.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • A scheduled stay at PACU for at least 3 postoperatively.

排除标准

  • Age <18 years

结局指标

主要结局

TCM changes

时间窗: 31-08-21

The primary outcome is changes in TCM recordings before and after clinical interventions and/or acute severe adverse events.

次要结局

  • ABG and TCM(31-08-21)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eske Kvanner Aasvang

Clinical professor

Rigshospitalet, Denmark

研究点 (1)

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