Remote Patient Monitoring for Preoperative Risk Assessment

Summary

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.

Conditions

• Abdominal Neoplasm
• Surgery
• Surgery-Complications
• Risk Assessment

Interventions

DEVICE

Lifesignals Wearable Sensor

The participants will wear the patch for 3-5 days and be provided with the mobile device, which records data transmitted wirelessly directly from the biosensor patch. During the monitoring period, participants can continue their normal activities. Remote monitoring will be undertaken using the CE-marked LifeSignals wearable biosensor. The biosensor communicates with a commercially available mobile device, which relays data to a secure Cloud server (GDPR compliant data transfer). 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. There will be no clinical intervention from the researchers if abnormalities in vital signs are picked up by the monitoring patch, as all data will be analysed retrospectively after the participant's operation. Any clinical concerns about the device that arise will be reported to the relevant clinical team.

Sponsors & Collaborators

• The Leeds Teaching Hospitals NHS Trust

  collaborator OTHER

• University of Leeds

  lead OTHER

Principal Investigators

• Alexios Dosis, MD · Leeds institute of Medical Research

Study Design

Allocation

NA

Purpose

PREVENTION

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-12-19

Primary Completion

2024-06-19

Completion

2024-10-01

FDA Device

Yes

Countries

• United Kingdom

Study Locations