NCT04068584已完成不适用
Evaluation of the Impact of the SMART ANGEL ™ Device on Follow-up at Home Following Major or Intermediate Outpatient Surgery: Randomized Controlled Open-label Trial
Centre Hospitalier Universitaire de Nīmes36 个研究点 分布在 1 个国家目标入组 1,260 人开始时间: 2020年2月3日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,260
- 试验地点
- 36
- 主要终点
- Rates of calls with nurses between groups
研究概览
简要总结
The investigators hypothesize that by monitoring and analyzing physiological parameters (heart rate, blood pressure, saturation) and well-being (pain, nausea, vomiting, comfort) the SMART ANGEL ™ device improves the quality of care after major or intermediate outpatient surgery. This active surveillance will result in a decrease in the rate of unplanned recourse (hospitalization, consultation, telephone call).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient must have given their free and informed consent and signed the consent form
- •The patient must be a member or beneficiary of a health insurance plan
- •The patient is undergoing ambulatory surgery for:
- •in orthopedics: shoulder (arthroscopy, abutment, prosthesis), hip (prosthesis, arthrolysis), knee (osteotomy, ligamentoplasty), ankle (prosthesis, ligamentoplasty) foot (hallux valgus); removal of major or multi-site equipment;
- •digestive (cholecystectomy, hernia repair, partial gastrectomy, colectomy, cleaning);
- •in gynecology (hysterectomy, oophorectomy, mastectomy, quadrantectomy, dissection, cystoplasty, sphincter);
- •in urology (total or partial resection of the prostate);
- •ENT (thyroidectomy, tonsillectomy);
- •Neurosurgery (herniated disc);
- •Vascular (stripping varix, creating fistula).
- •The patient has sufficient intellectual and cognitive capacity to use the devices
- •The patient must pass the test performed during the anesthesia consultation, namely:
- •open and connect the tablet,
- •activate the measurement of the blood pressure and the measurement of the oxygen saturation,
- •be connected to a 4G network
排除标准
- •The subject is in a period of exclusion determined by a previous study
- •The subject refuses to sign the consent
- •It is impossible to give the subject informed information
- •The patient is under safeguard of justice or state guardianship
- •The patient is pregnant
- •The patient is undergoing emergency or minor surgery
- •Patient has a psychological class ASA 5
- •Patient is non-eligible for ambulatory surgery for medical reasons (decompensated medical pathology) or social reasons according to the criteria defined by the société française anesthésie réanimation. Person lives alone or has a geographical distance from a hospital center> 30 km (or> 45 min by car).
- •Patient who doesn't classify for ambulatory surgery at time of discharge
研究组 & 干预措施
Complete Smart Angel
Experimental
Smat Angel application with artificial intelligence
干预措施: Smart Angel (Other)
Basic Smart Angel
Experimental
Smat Angel application without artificial intelligence
干预措施: Smart Angel (Other)
Control
No Intervention
结局指标
主要结局
Rates of calls with nurses between groups
时间窗: Day 5
%
Non-scheduled hospitalization rates between groups
时间窗: Day 5
%
Number of non-scheduled consultations between groups
时间窗: Day 5
%
Rates of calls with doctors between groups
时间窗: Day 5
%
Rates of unplanned prescriptions between groups
时间窗: Day 5
%
Rates of unplanned exams between groups
时间窗: Day 5
%
次要结局
- Rate of complications between groups(Month 1)
- Rate of readmission between groups(Month 1)
- Date of return to work or other activity(1 Month)
- Patient satisfaction(Day 6)
- Patient quality of life(1 month)
- Difficulties in using the device(Day 5)
- Requirement of external help in using the device(Day 5)
- Times spent on device(Day 5)
- Technical errors arising(Day 5)
研究者
研究点 (36)
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