A Parallel Cluster-randomized Trial of the Integrated Pulmonary Index for Nurse-administered Procedural Sedation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 401
- 试验地点
- 1
- 主要终点
- Number of seconds in an alert condition state from the Medtronic Capnostream 35p monitor without an intervention being applied.
研究概览
简要总结
Implementing capnography into practice for respiratory monitoring during sedation is considered a high priority by leading authorities in Canada and internationally. The Canadian Anesthesiologists' Society's position statement recommends that capnography should be available wherever moderate or deep sedation is used. The Academy of Medical Royal Colleges (UK) Standard and Guidance report on Safe Sedation Practice for Healthcare Procedures noted that while capnography is not a mandated practice, providers should consider implementing capnography as a long term goal. These recommendations are in place because sedated patients who are not monitored with capnography have frequent undetected, and therefore untreated, respiratory depression. Of note, though, these guidelines do not provide specific recommendations for how capnography should be implemented for nurse-administered sedation. The aim of this study is to determine if smart alarm guided treatment of respiratory depression using the Integrated Pulmonary Index is an effective way to implement capnography during nurse-administered sedation. The primary outcome is the number of seconds in an alert condition state without an intervention being applied. The IPI is intended to reduce the cognitive burden of synthesizing multiple sources of physiological monitoring input and hence lowering the threshold for triggering intervention by clinicians to support respiration. The primary outcome directly measures this concept by quantifying the time taken for an alert to trigger an intervention.
Higher values of the primary outcome will result from either a problem state that should have triggered an intervention but did not, or an 'inappropriate' alert (i.e. an alert that was not important enough to warrant immediate intervention.)
详细描述
A hybrid effectiveness-implementation design will be used for this study, incorporating a parallel cluster randomized trial. Capnography monitoring will be implemented as standard practice for all patients undergoing procedures with nurse-administered sedation in the four departments participating in the study, as per recommendations for procedural sedation in Canada. Nurses working in the four departments will be invited to choose to participate in the randomized controlled trial component of the study. If they choose to participate, they will be randomized to use capnography either with or without the Integrated Pulmonary Index (IPI) enabled.
There will be establishment and stability phases where the implementation of capnography (with or without IPI enabled) into practice commences and is optimized through an audit and feedback process. Data collection for the primary outcome will be undertaken during the evaluation period. This design was chosen for two main reasons. First, it allows for the establishment phase, which will provide the time required for the research team to meaningfully engage with staff at each department and recruit nurses to participate in the randomized controlled trial component of the study. Second, the stability period will involve sustained engagement with clinicians in the department, regardless of assignment, in order to optimize the implementation of capnography monitoring (with or without the IPI enabled) into practice using a facilitated audit and feedback process.
Sedation management and monitoring
Medication
There will be no restrictions on sedation dosing for this study. It is typical for a bolus dose of 25-50mcg of fentanyl followed by 1-2mg of midazolam to be administered approximately two to five minutes prior to procedure commencement. Further doses of 1mg midazolam and 25mcg fentanyl are usually administered at the discretion of the proceduralist to maintain sedation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Number of seconds in an alert condition state from the Medtronic Capnostream 35p monitor without an intervention being applied.
时间窗: From the time between first sedative medication administration to the end of the procedure. Estimated duration of procedures is 30 minutes to 120 minutes.
Continuous capnography measurements will be recorded using the Medtronic Capnostream 35p monitor.
次要结局
- Total number of Medtronic Capnostream 35p monitor alarms(From the time between first sedative medication administration to the end of the procedure. Estimated duration of procedures is 30 minutes to 120 minutes.)
- Number of appropriate alarms (defined as an alarm that triggered an intervention(From the time between first sedative medication administration to the end of the procedure. Estimated duration of procedures is 30 minutes to 120 minutes.)
- Number of inappropriate alarms (defined as alarms that were triggered but manually dismissed by silencing the alarm)(From the time between first sedative medication administration to the end of the procedure. Estimated duration of procedures is 30 minutes to 120 minutes.)
- Duration of alert conditions (defined as the total time that an alert condition was active)(From the time between first sedative medication administration to the end of the procedure. Estimated duration of procedures is 30 minutes to 120 minutes.)
- Adverse sedation events(From the time between first sedative medication administration to the end of the procedure. Estimated duration of procedures is 30 minutes to 120 minutes.)
- Area under the curve of oxygen desaturation(From the time between first sedative medication administration to the end of the procedure. Estimated duration of procedures is 30 minutes to 120 minutes.)
研究者
Aaron Conway
Assistant Professor
University Health Network, Toronto