Clinical trial · Interventional
Remote Patient Monitoring for Preoperative Risk Assessment
REmote Monitoring for preOperaTive Risk assEssment for Major Abdominal Surgery
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Abdominal Neoplasm | — | UNRESOLVED | — |
| Risk Assessment | — | UNRESOLVED | — |
| Surgery | — | UNRESOLVED | — |
| Surgery-Complications | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lifesignals Wearable Sensor | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Remote monitoring
- description
- Participants that consent to the study will undergo additional remote monitoring with the applied wearable sensor.
- interventionNames
- Device: Lifesignals Wearable Sensor
Primary outcomes (2)
- measure
- Recruitment rates
- timeFrame
- up to 18 months
- description
- Ratio of patients recruited in the study to overall number of eligible patients approached
- measure
- Utility as measured by the System Usability Questionnaires.
- timeFrame
- up to 18 months
- description
- Will be assessed with System Usability score questionnaires filled by participants
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * Patients allergic to skin adhesive * Patients with a cardiac pacemaker * Patients who do not need to undergo CPET for preoperative assessment
References
Publications (0)
Data not yet available