REmote Monitoring for preOperaTive Risk assEssment for Major Abdominal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Recruitment rates
研究概览
简要总结
Preoperative risk assessment (an evaluation of overall health before surgery) is important to determine the overall risk of mortality and complications for patients undergoing major abdominal surgery to allow the appropriate allocation of sparse hospital resources. The current gold standard for preoperative assessment is cardiopulmonary exercise testing (CPET). CPET is, however, not available in all centres that perform major surgery, it is a costly test, and therefore only high-risk patients are tested. Finding new ways of conducting preoperative assessment could improve overall surgical safety, patient experience and reduce cost.
The preoperative use of remote vital signs monitoring can provide important information about the patients' fitness and overall health and may be used for preoperative assessment. This study will use a remote monitoring patch to monitor patients' vital signs before surgery. The aim is to evaluate the utility and patient acceptability of the remote monitoring system and the feasibility of a randomised controlled trial of this type of assessment. Additionally, the study will assess the correlation between the data captured by the remote monitoring system and the CPET results to evaluate the remote monitoring system's ability to predict risk of surgery.
The study will take place in Leeds Teaching hospitals. Adult patients undergoing major abdominal surgery that require CPET before surgery are eligible. Participants will be monitored at home with the patch monitor for 3-5 days before surgery, in addition to their planned preoperative assessment. During remote monitoring, patients will be asked to complete questionnaires on their general health and experience using the patch paired with the mobile phone as part of the monitoring system. Clinical data from the electronic hospital records and general practitioner records available on the trust system will then be collected after surgery to assess complications and calculate risk scores.
详细描述
The clinical research team will identify eligible participants from standard CPET booking forms, which are received 1 - 2 weeks prior to the test. Researchers involved in this single centre study are part of the clinical care team and have routine access to patient identifiable information. Participants fulfilling the eligibility criteria will be sent a Patient Information Sheet (PIS) explaining the study to accompany the routine appointment letter. Participants attending their CPET appointment will be approached for inclusion in the study by the clinical research team. Participants willing to take part in the study will be asked to provide written, informed consent. CPET will be undertaken in the usual manner, after which the patient will be fitted with a wearable patch and trained to use the remote monitoring software/mobile device. A dedicated mobile device will be provided for the duration of the remote monitoring and returned when the patient is admitted for surgery.
The participants will wear the patch for 3 to 5 days and be provided with the mobile device (modified smartphone), which records data transmitted wirelessly directly from the biosensor patch. During the monitoring period, participants can continue their normal activities as usual. The patch is water resistant, so participants can shower and pat dry the patch with a towel.
The system (patch - mobile device) is reliable and secure, using robust Wi-Fi radio encryption and GDPR (General Data Protection Regulation) compliant data transfer to a separate cloud server. The device cannot be used as a regular phone to make phone calls/browse the web. In the unfortunate event that a device gets lost/ broken, or stolen, the participant will not be liable.
Remote monitoring will be undertaken using the LifeSignals wearable biosensor (www.LifeSignals.com) and the Asclepius software platform. The biosensor communicates with a commercially available mobile device, which relays data to a secure Cloud server. The biosensor is CE-marked and has been used in other clinical settings for remote patient monitoring. The device is currently not routinely used in the NHS.
Participants will subsequently undergo their planned surgery in the usual way. Data captured from the remote monitoring will not be used or made accessible to inform decisions about clinical care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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 undergoing elective major abdominal surgery (BUPA classification: Major 1 to +5) [36]
- •Patients who can be trained to use the remote monitoring software on a dedicated smartphone
- •Patients who have the capacity to provide informed, written consent
- •Patients referred for CPET as part of routine preoperative assessment
- •Ages ≥ 18 years
- •Patients who can comprehend verbal and written English
排除标准
- •Patients allergic to skin adhesive
- •Patients with a cardiac pacemaker
- •Patients who do not need to undergo CPET for preoperative assessment
结局指标
主要结局
Recruitment rates
时间窗: up to 18 months
Ratio of patients recruited in the study to overall number of eligible patients approached
Utility as measured by the System Usability Questionnaires.
时间窗: up to 18 months
Will be assessed with System Usability score questionnaires filled by participants
次要结局
- Acceptability of the Remote monitoring system as evidenced by qualitative interviews.(up to 18 months)
- Number of Predictors extracted from the wearable data.(up to 21 months)
研究者
David Jayne
Professor of Surgery
University of Leeds