Wireless Assessment of Respiratory and Circulatory Distress; A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Blood oxygen saturation resulting in a single parameter score of 3 according to EWS algorithm
研究概览
简要总结
Postoperative observation of patients is based on the Early Warning Score (EWS). By using continuous wireless monitoring of vital parameters it may be possible to predict the risk of complications after abdominal cancer surgery. The object of this pilot study is to test the equipment and methods for the next phases. Patients will be monitored for 4 days postoperatively and data is analyzed retrospectively. Vital parameters are monitored with ECG, blood pressure monitor and pulseoximetry.
In the analysis the investigators will compare the results from the continuous monitoring to the measurements made by the nurses and registered in the EWS. The primary outcomes for the pilot study are the frequency of measurements resulting in a single parameter score of 3 according to the EWS algorithm.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of cancer of either esophagus, stomach, pancreas, liver, colon or rectum.
- •Elective surgery with curative intention at Bispebjerg Hospital or Rigshospitalet in Copenhagen, Denmark.
- •Estimated duration of surgery > 2 hours
- •> 65 years
- •Preoperative ECG showing sinus rhythm
- •No treatment limitations
- •Fit to receive optimized care according to the regimens on the given wards
排除标准
- 未提供
结局指标
主要结局
Blood oxygen saturation resulting in a single parameter score of 3 according to EWS algorithm
时间窗: The patients are monitored for 4 days
Hypoxemia: arterial oxygen saturation \< 92 %
Heart rate resulting in a single parameter score of 3 according to EWS algorithm
时间窗: The patients are monitored for 4 days
All data from the monitoring will be analyzed using the thresholds from the EWS algorithm and will be sorted into relevant categories. The following thresholds are used: Bradycardia: pulse \< 41 bpm Tachycardia: pulse \> 130 bpm
Respiration rate resulting in a single parameter score of 3 according to EWS algorithm
时间窗: The patients are monitored for 4 days
Bradypnea: \< 9 breaths/min Tachypnea: \> 24 breaths/min
Blood pressure resulting in a single parameter score of 3 according to EWS algorithm
时间窗: The patients are monitored for 4 days
Hypotension: Systolic blood pressure \< 91 mmHg Hypertension: Systolic blood pressure \> 219 mmHg
次要结局
未报告次要终点
研究者
Camilla Lundgreen Duus
Research Assistant
Bispebjerg Hospital