Remote Patient Monitoring for Preoperative Risk Assessment

NCT06042023 | Unknown FDA Device

• 1 other identifier: GS22/148530
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Recruitment rates

  Ratio of patients recruited in the study to overall number of eligible patients approached

  up to 18 months

• Utility as measured by the System Usability Questionnaires.

  Will be assessed with System Usability score questionnaires filled by participants

  up to 18 months

Secondary Outcomes (2)

• 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

Study Arms (1)

Remote monitoring

EXPERIMENTAL

Participants that consent to the study will undergo additional remote monitoring with the applied wearable sensor.

Device: Lifesignals Wearable Sensor

Interventions

Lifesignals Wearable Sensor DEVICE

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.

Remote monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients allergic to skin adhesive
• Patients with a cardiac pacemaker
• Patients who do not need to undergo CPET for preoperative assessment

Sponsors & Collaborators

• University of Leeds: lead
• The Leeds Teaching Hospitals NHS Trust: collaborator

Study Sites (1)

Leeds Teaching Hospitals

Leeds, LS9 7TF, United Kingdom

RECRUITING

MeSH Terms

Conditions

Abdominal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Alexios Dosis, MD

  Leeds institute of Medical Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Jane, MD

CONTACT

+44(0)1132065281; d.g.jayne@leeds.ac.uk

Alexios Dosis, MD

CONTACT

+44(0)7754226212; a.dosis@leeds.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: September 4, 2023
• First Posted: September 18, 2023
• Study Start: December 19, 2022
• Primary Completion: June 19, 2024
• Study Completion: October 1, 2024
• Last Updated: September 18, 2023

Record last verified: 2023-09

Locations

GB (1)