Impact on the Time to Diagnosis of Serious Post-operative Complications of Continuous, Individualised, Alert Monitoring of SpO2, Heart Rate and Respiratory Rate by a Controlled Connected Medical Device (SMART ANGEL Intra )
试验速览
- 阶段
- 不适用
- 入组人数
- 2,000
- 试验地点
- 2
- 主要终点
- Difference in response times for nurses
研究概览
简要总结
Post-operative mortality in case of scheduled surgery is 3% in France (Lancet 2013) mainly due to cardiovascular or respiratory complications, by decompensation of pre-existing pathologies.
Complications due to the medical practice are the third cause of morbidity (BMJ, 2016). More than half are preventable and are mainly observed in surgical patients. In conventional hospitalization, excluding intensive care, monitoring is done discontinuously for most of the patients, which does not allow early diagnosis of a vital cardiovascular or respiratory failure.
Diagnosis and late treatment do not allow good recovery. The early identification of a vital failure by the continuous monitoring of three simple physiological parameters (SpO2, heart rate and respiratory rate) would allow faster management by the hospital staff and a reduction in immediate and possibly delayed postoperative mortality.
详细描述
The challenge of this research is to transpose in an ordinary hospitalization unit the continuous monitoring of vital functions carried out in intensive care by the continuous measurement of simple parameters using the "SMART ANGEL Intra-hospital" System's (connected medical devices and alerts).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Age ≥ 18 years
- •Patients receiving a scheduled non-ambulatory surgical or interventional procedure
- •Affiliation to a social security scheme, beneficiary or entitled person (excluding AME)
- •Patient's written consent or of the trusted person in case of physical incapacity
排除标准
- •Inclusion in emergency situations
- •ASA1 patient (without associated pathology)
- •Patient with a multi-drug resistant germ in isolation
- •Known linguistic inability of the patient to understand the study
- •Known pregnancy or breastfeeding woman
- •Patients with implantable pacemakers, implantable defibrillators or neurostimulators.
- •Person under legal protection or unable to give consent
- •Person deprived of liberty by judicial or administrative decision
结局指标
主要结局
Difference in response times for nurses
时间窗: between inclusion visit and day 30
Difference in response times between the two groups as measured by the difference between the exact time of occurrence of the complication and the time of caregiver intervention.
次要结局
- Length of stay(between inclusion visit and day 30)
- Mortality during hospitalisation(between inclusion visit and day 30)
- Rate of calls to the doctor on duty(between inclusion visit and day 30)
- Percentage of re-hospitalization within 30 days(between inclusion visit and day 30)
- Percentage of hospitalisations in follow-up care and rehabilitation care units(between inclusion visit and day 30)
- Mortality within 30 days of surgery(between inclusion visit and day 30)
- Percentage of transfers to intensive care unit(between inclusion visit and day 30)
- ICU length of stay(between inclusion visit and day 30)
- Percentage of patients managed at home(between inclusion visit and day 30)
- False positive rate(between inclusion visit and day 30)
- Acceptability of care teams(between inclusion visit and day 30)
- Incremental cost-effectiveness ratio(between inclusion visit and day 30)
- Patient acceptability(between inclusion visit and day 30)