LIFEGUARD Study - Continuous Respiratory Monitoring on the General Ward
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 4
- 主要终点
- Quantify the Incidence and Severity of Post-operative Respiratory Compromise Markers
研究概览
简要总结
The purpose of this study is to document how often and how severe are the breathing difficulties that patients suffer, while recovering on a general ward following a serious operation
详细描述
This is a prospective, 2-center, 2-phase pilot study of post-surgical adult patients on the hospital ward at high risk of developing respiratory and cardiovascular events. Phase I, 70 patients will be 1:1 randomly allocated to Capnostream 20p monitoring system or to PM1000N-RR pulse oximeter monitoring system and the alarms of both devices will be silenced and the screen information blinded, to establish a baseline for the incidence of respiratory events. Phase II, 140 patients will be 1:1 randomly allocated to Capnostream 20p or to PM1000N-RR monitoring but the screen information will be visible at the bedside and through the Vital Sync™ remote patient monitoring system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Care Provider)
盲法说明
During the study Phase I, the alarms of both devices will be silenced and the screen information blinded, as is the current clinical practice. During the study Phase II, the screen information will be available and the nursing staff will be instructed to respond to both devices' alarms based on a pre-defined hospital protocol.
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
- •Non-cardiac post-surgical patients at high risk of developing respiratory and cardiovascular events (High or intermediate risk for postoperative pulmonary complications).
- •Adult age (≥18 year old).
- •Patient is able and willing to give informed consent.
排除标准
- •Expected ward length of stay ≤24 hours.
- •Post-surgical patients with American Society of Anesthesiologists physical status (ASA PS) V or higher.
- •Ventilated or intubated patients.
- •Patient is unwilling or unable to comply fully with study procedures due to any disease condition which can raise doubt about compliance
- •Patient is a member of a vulnerable population regardless of authorized representative support.
- •Patient is participating in another potentially confounding drug or device clinical study.
结局指标
主要结局
Quantify the Incidence and Severity of Post-operative Respiratory Compromise Markers
时间窗: 72 hours
Respiratory Compromise markers are identified by continuous monitoring to determine the benefit of continuous monitoring on the general ward
次要结局
- Evaluate 2 Different Monitoring Devices(72 hours)