TELEsurveillance of Patients in PostopErative Bridge surgeryAge CoronairE, Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- scar appearance
研究概览
简要总结
More than 20,000 patients benefit from coronary bypass surgery in France each year. Median discharge without complication is eight days postoperatively, whereas by day four after surgery, hospitalization is only necessary for medical supervision of the occurrence of complications (scar infection, atrial fibrillation, pericardial effusion), waiting for a downstream bed in cardiac rehabilitation.
Some studies have shown the feasibility of a return home from day 4 after CABG in the United States and England under some conditions of selection and monitoring of patients.
However, there is currently no validated telemonitoring tool for patients in early postoperative coronary bypass surgery.
In this pilot study, during hospitalization for early postoperative coronary bypass surgery, a combination of connected devices for the measurement of physiological parameters and for clinical self-evaluation by the patient will be evaluated. The results of this project will be used as a basis for a future larger study in which an early home discharge can be proposed to patients.
详细描述
More than 20,000 patients benefit from coronary bypass surgery in France every year. In the case of simple follow-up, the median discharge is eight days postoperatively, whereas by day 4 after surgery, hospitalization is only necessary for medical supervision of the occurrence of complications (scar infection, atrial fibrillation, pericardial effusion), waiting for a downstream bed in cardiac rehabilitation.
Some studies have shown the feasibility of a return home from day 4 after CABG in the United States and England under some conditions of selection and monitoring of patients.
However, there is currently no validated telemonitoring tool for patients in early postoperative coronary bypass surgery.
This is a prospective pilot study, monocentric, open. The intervention consists of the use of connected devices for the monitoring of physiological parameters and functional signs.The use of the connected objects by the patient will take place during hospitalization, in parallel of a standard medical and paramedical follow-up (usual care), from day 4 after coronary bypass a to discharge (or until day 12 maximum, ie 8 days of follow-up).
A combination of connected objects for the measurement of physiological parameters and for clinical self-evaluation by the patient, during early postoperative coronary bypass surgery will be evaluated.
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
- •Patients 18 years of age or older at baseline
- •Patient for whom isolated coronary bypass was performed
- •From the 4th day after the operation, epicardial electrodes removed since at least the day before inclusion day, normal blood pressure and heart rate, O2 saturation greater than 94% in ambient air, apyrexia, clean scar, not sign of congestive heart failure
- •From the 4th day after surgery, ECG of the day in sinus rhythm
- •From the 4th day after surgery, hemoglobin> 8g / dl, creatinine clearance> 30ml / min, during a blood sample of less than 24 hours
- •From the 4th day after the operation, no significant abnormalities during a chest X-ray less than 24 hours
- •From the 4th day after surgery, FEVG> 30%, dry pericardium or pericardial effusion ≤ 1cm without compression during transthoracic echocardiography less than 24 hours
排除标准
- •Patients at high risk of complications:
- •Insulinorequising diabetics,
- •Non-autonomous,
- •With a context unfavorable to the implementation of the intervention: patient speaking little or no French, patient without social coverage, patient unable to manage complex actions on connected tools.
- •Refusal to sign the consent. Protected persons (tutorship, safeguard of justice)
结局指标
主要结局
scar appearance
时间窗: day 12 postoperatively or discharge from hospital
The Evolution of scar appearance will be measured daily by photography, from day 4 postoperatively to discharge from hospital.
pain measured
时间窗: day 12 postoperatively or discharge from hospital
The Evolution of pain will be measured daily by an electronic analog visual pain scale, from day 4 postoperatively to discharge from hospital.
Temperature measured by connected thermometer
时间窗: day 12 postoperatively or discharge from hospital
The Evolution of Temperature will be measured daily by connected thermometer, from day 4 postoperatively to discharge from hospital.
Heartbeat measured by connected electrocardiogram
时间窗: day 12 postoperatively or discharge from hospital
The heartbeat will be measured daily by connected electrocardiogram, from day 4 postoperatively to discharge from hospital.
Blood pressure measured by connected armband
时间窗: day 12 postoperatively or discharge from hospital
The Evolution of blood pressure will be measured daily by connected armband, from day 4 postoperatively to discharge from hospital.
次要结局
- photography of scar(day 12 postoperatively or discharge from hospital)
- Technical failures of connected objects.(day 12 postoperatively or discharge from hospital)
- post-operative complications after discharge from hospital(1 month)
- Connected thermometer measurements.(day 12 postoperatively or discharge from hospital)
- Connected electrocardiogram(day 12 postoperatively or discharge from hospital)
- items completed by the patient in the application(day 12 postoperatively or discharge from hospital)
- analog visual pain scale(day 12 postoperatively or discharge from hospital)
- Caregiver satisfaction(day 12 postoperatively or discharge from hospital)
- Connected armband measurements(day 12 postoperatively or discharge from hospital)
- alert algorithms for the diagnosis of postoperative complications(day 12 postoperatively or discharge from hospital)
- Time between surgery and when the patient meets inclusion criteria(day 8 postoperatively)
- self-measurements performed by the patient(day 12 postoperatively or discharge from hospital)
- Patient satisfaction(1 month)