Ancillary Study: Monitoring of Patients After Ambulatory Surgery by Biobeat® Devices: Pilot Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Percentage of patients with no loss of data for a period of 2 consecutive hours over the entire follow-up period.
研究概览
简要总结
The objective of this ancillary study of the MEET-OS study is to assess the technical feasibility of using Biobeat® monitoring devices after ambulatory surgery at high risk of complications.
The secondary objectives are to assess: i) the patient's experience and tolerance ii) the occurrence of clinical disturbances in the patients's home after ambulatory surgery with high risk of postoperative complications iii) to determine the impact of the data obtained with the monitoring devices on the clinical care decisions during postoperative follow-up.
详细描述
With increasingly complex surgeries and increasingly comorbid patients, ambulatory surgery are not always at low risk of postoperative complications. Among the new support tools available for monitoring patients remotely, devices for monitoring vital signs could be of interest to healthcare staff in charge of monitoring, more precisely when comorbid patients are involved or when interventions at high risk of complications are performed.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years old undergoing elective outpatient surgery under general or regional anesthesia
- •Internet access for the patient or their caregiver from home
- •Written, oral and spoken comprehension of French
- •Considered to be at high risk of postoperative complications, defined by one of the following two criteria: an ASA 3 score or an ASA score of 2 + surgery at intermediate or high risk according to the classification of Glance and al.
排除标准
- •Patient's or caregiver's inability to learn and to use digital technologies
- •Conversion of ambulatory to inpatient hospitalization on the day of surgery
- •Patient's refusal
- •Operation performed under regional or neuraxial anesthesia alone
- •Trophic skin disorders contraindicating the installation of the Biobeat® monitoring device on the torso (deformation, irritation, infection, ulceration, etc.)
- •Patient with pacemaker
- •MRI or CT scheduled post-operatively
- •Tattoo on the torso or refusal to shave the area where the Biobeat® monitoring device should be installed
- •Pregnant or breastfeeding women
- •Allergy to one of the technological components
结局指标
主要结局
Percentage of patients with no loss of data for a period of 2 consecutive hours over the entire follow-up period.
时间窗: From the installation of the monitoring device after the surgery up to 5 days postoperatively.
次要结局
- Percentage of patients with no data loss for 1, 4, 6, and 8 consecutive hours over the entire follow-up period.(From the installation of the monitoring device after the surgery up to 5 days postoperatively.)
- Percentage of patients with data loss of one hour or more preceding a postoperative event.(From the installation of the monitoring device after the surgery up to 5 days postoperatively.)
- Frequency of occurrences and the cumulative time of clinical disturbances(From the installation of the monitoring device after the surgery up to 5 days postoperatively.)
- Percentage of appropriate and inappropriate clinical decision changes from the clinical intervention decided by the expert committee will be assessed.(Up to 60 days after surgery)
- Percentage of useful data available per day for the interpretation of vital signs during the first 5 days(From the installation of the monitoring device after the surgery up to 5 days postoperatively.)
- Patient's experience(7 days after the surgery)