Real-time Evaluation and Continuous Observation of Vital Signs for Enhanced Recovery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Number of event of desaturation
研究概览
简要总结
This study aims to evaluate whether continuous vital sign monitoring with wearable devices can help detect postoperative complications in surgical ward earlier than standard hospital monitoring. In particular, the goal of this observational study is to evaluate if the wireless wearable devices Portrait Mobile (GE Healthcare) can detect early signs of complications after major urologic surgery in adults who are not eligible for intensive care unit admission. The main questions it aims to answer are:
- Can continuous monitoring of vital signs (heart rate, breathing rate, blood oxygen) detect health problems earlier than standard nurse checks in the urology ward?
- How many times do participants' vital signs change in ways that suggest a complication is developing during the first days after surgery?
- Does the vital sign trend and/or the deviation from patients' baseline suggest a complication is developing during the first days after surgery?
- Does continuous monitoring help healthcare providers intervene before patients become critically ill thus reducing complications burden or severity and reducing unplanned intensive care admission? Participants in the intervention cohort will wear a wireless patch-like device on their chest that continuously tracks their heart rate, breathing rate, and blood oxygen levels. The device sends this information to hospital staff through a secure wireless connection while participants recover in the regular urology ward after surgery. Participants in the intervention cohort will wear the device for 3 days after surgery or until they leave the hospital. Healthcare providers will receive alerts if vital signs change in ways that suggest a complication may be developing. This may help providers treat problems earlier and prevent patients from becoming critically ill. All participants will also receive standard post-surgical care, including regular nurse checks of vital signs.
详细描述
The RECOVER study evaluates the use of continuous wearable monitoring in surgical ward for the early detection of postoperative complications in patients recovering after major surgery. The study begins with the evaluation of urologic surgery. It focuses on whether continuous measurement of vital signs in the surgical ward can identify clinical deterioration and postoperative complications earlier than routine postoperative surveillance alone: postoperative complications are often preceded by changes in vital signs and may develop during the first days after surgery, when patients are usually monitored intermittently in the ward. Continuous wireless monitoring is intended to provide earlier recognition of respiratory and hemodynamic deterioration while patients recover outside the operating room and outside intensive care.
The main objective is to assess whether continuous monitoring of vital signs can detect early signs of medical or surgical postoperative complications after moderate-to-high complexity urologic surgery performed under general anesthesia. The protocol is particularly focused on identifying episodes of desaturation, tachypnea, hemodynamic instability, and persistent deviation of vital signs from patient's baseline values during the postoperative period.
Patient enrollment takes place in the Urology ward before the scheduled operation. During the preoperative anesthesiology evaluation, the anesthesiologist provides study information and asks the patient to participate by signing informed consent and personal data processing forms. This enrollment process is maintained in both patient pathways described in the protocol.
For patients managed with continuous monitoring, the wearable system is applied on the evening before surgery so that baseline vital sign values can be collected under resting conditions. Monitoring is interrupted before transfer to the operating room and restarted after the patient returns from surgery to the ward. The patient then wears the system for at least 72 hours after surgery, and the device does not replace standard postoperative monitoring.
The wearable platform used in the protocol is the Portrait Mobile® system by GE HealthCare. It continuously records respiratory rate, oxygen saturation, and heart rate, while blood pressure and EKG continues to be measured intermittently according to usual ward practice in order to maintain the non-intensive care settings and the actual patient-nurse ratio. Data are transmitted through the hospital Wi-Fi network to a dedicated monitoring infrastructure, where alarms can be visualized on the ward monitoring station.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Ability to give informed consent and consent to the processing of personal data by signing the relevant forms;
- •Aged over 18 years old
- •Medium-to-high complexity urological surgery without the need for post-operative monitoring in the Intensive Care Unit
- •Surgery performed under general anaesthesia
- •Discharge to the ward is scheduled upon leaving the operating theatre
排除标准
- •Refusal or inability to consent to participation
- •Patients under 18 years old
- •Planned admission to Post-Operative Intensive Care Unit after the surgery
- •Unplanned admission to the Post-Operative Intensive Care Unit at the end of the surgery
- •Anaesthetic technique other than general anaesthesia.
结局指标
主要结局
Number of event of desaturation
时间窗: 72 hours after the surgery
An 'event' among the primary outcomes will be those used by the National Early Warning System Score (NEWS: Respiratory rate \<11 and \>21 breaths/min; SpO₂ \<95%; Heart rate \<50 bpm and \>91 bpm)
Number of event of tachypnoea or bradypnoea
时间窗: 72 hours after the surgery
An 'event' among the primary outcomes will be those used by the National Early Warning System Score (NEWS: Respiratory rate \<11 and \>21 breaths/min; SpO₂ \<95%; Heart rate \<50 bpm and \>91 bpm)
Number of event of haemodinamic instability
时间窗: 72 hours after the surgery
An 'event' among the primary outcomes will be those used by the National Early Warning System Score (NEWS: Respiratory rate \<11 and \>21 breaths/min; SpO₂ \<95%; Heart rate \<50 bpm and \>91 bpm)
次要结局
- Number of requests for Anesthesia consultation(72 hours after surgery)
- False-positive rate(72 hours after the surgery)
- Number of on-call doctor call-outs(72 hours after the surgery)
- Unscheduled direct admission to the Intensive Care Unit from the operating theatre and unplanned transfer to the Intensive Care Unit during the post-operative period (from the surgical ward)(72 hours after surgery)
- Occurrence of post-surgical complications (any type) or reoperation(72 hours after surgery or patients discharge)
- Correlation between parameters trend, including persistent deviation from pre-operative values, and patient outcome or length of hospital stay.(Untill patient discharge from hospital)
- Barriers to patient rehabilitation and patients satisfaction(72 hours after surgery or discharge)
研究者
Valentina Bellini
Prof.
Azienda Ospedaliero-Universitaria di Parma
