Detection of Postoperative Complications and Particularly Hemodynamic Ones Through Continuous Monitoring Using the Biobeat Patch
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Hopital Foch
- 入组人数
- 109
- 试验地点
- 4
- 主要终点
- Proportion of patients with a hemodynamic abnormality using the data obtained using the Biobeat patch.
研究概览
简要总结
Brief Summary: Post-operative morbidity remains a reality as shown by the International Surgical Outcomes Study published in 2016 and 2019 and by several recent publications which focus mainly on hypotension and cardio-vascular complications. Other complications, such as respiratory depression, are less often studied. The hypothesis is that this connected patch could be used in surgical departments to detect a postoperative complication.
Biobeat Technologies Ltd has developed a sensor which continuously records the photoplethysmographic waveform and allows the calculation of several physiological parameters: heart rate (HR), oxygen saturation (SpO2), systolic blood pressure (SBP), diastolic blood pressure (DBP), stroke volume (SV), cardiac output (CO), cardiac index (CI), systemic vascular resistance (SVR), respiratory rate (RR), and temperature.
The objective of this study is the quantification of hemodynamic, respiratory and temperature abnormalities detected by routine monitoring (routine nursing follow-up) and continuous monitoring by the Biobeat patch during the first 72 postoperative hours.
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
- •Patient 18 years of age or older
- •Patient undergoing major digestive, gynecological, orthopedic or urological surgery (expected duration of surgery greater than 2 hours).
- •Predictable postoperative hospitalization duration ≥ 2 nights
- •Patient with a Health Insurance plan
- •Not having opposed participation in the research
排除标准
- •Patient with significant deformity, swelling, irritation or with localized infection, ulceration or skin lesions on the torso
- •Patient with a subcutaneous electronic pacemaker implant.
- •Patient with a CT or MRI scan already scheduled for the first three days postoperatively
- •Patient suffering from tremors or convulsions
- •Patient with a torso tattoo
- •Patient with significant chest hairiness
- •Patient with a known allergy to metals, plastics and silicone
- •Patient deprived of liberty or under guardianship
- •Pregnancy or breastfeeding
结局指标
主要结局
Proportion of patients with a hemodynamic abnormality using the data obtained using the Biobeat patch.
时间窗: 72 hours
A hemodynamic abnormality is defined as an mean Blood Pressure (MBP) \< 60 mmHg
次要结局
- Proportion of patients with a postoperative respiratory abnormality using the data obtained using the Biobeat patch.(72 hours)
- Proportion of patients with hypotension detected by the routine nursing follow-up.(72 hours)
- Proportion of patients with a temperature abnormality using the data obtained using the Biobeat patch.(72 hours)
- Collection of postoperative complications that occurred during the monitoring period(72 hours)
- Evaluation of patients' tolerance to wearing the Biobeat device(72 hours)
- Proportion of patients with a postoperative respiratory abnormality detected by the routine nursing follow-up.(72 hours)
- Quantify and compare the frequency of temperature abnormality detected by the routine nursing follow-up.(72 hours)
- Concerning the Biobeat patch, frequency of artifacts or of absence of data(72 hours)