Remote monitoring of vital signs for assessing surgery risks
REmote Monitoring for preOperaTive Risk assEssment for Major Abdominal Surgery
This study tests if a remote monitoring patch can help doctors better understand the health of patients before major abdominal surgery to make the surgery safer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Leeds Academic / other |
| Locations | 1 site (Leeds) |
| Trial ID | NCT06042023 on ClinicalTrials.gov |
What this trial studies
This study evaluates the use of a remote monitoring patch to assess preoperative risk in patients undergoing major abdominal surgery. By monitoring vital signs remotely, the study aims to provide valuable insights into patients' overall health and fitness, potentially improving surgical safety and resource allocation. Participants will wear the patch for 3 to 5 days while continuing their normal activities, and data will be transmitted wirelessly to a dedicated mobile device. The study seeks to determine the utility and acceptability of this remote monitoring approach compared to traditional methods.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are scheduled for elective major abdominal surgery and require cardiopulmonary exercise testing.
Not a fit: Patients who do not require CPET for preoperative assessment or have contraindications such as allergies to skin adhesive or cardiac pacemakers may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance preoperative assessments, leading to safer surgeries and better patient outcomes.
How similar studies have performed: While the use of remote monitoring in preoperative assessments is a novel approach, similar studies have shown promise in improving patient monitoring and outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Leeds
- Leeds Teaching Hospitals — Leeds, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Alexios Dosis, MD — Leeds institute of Medical Research
- Study coordinator: David Jane, MD
- Email: d.g.jayne@leeds.ac.uk
- Phone: +44(0)1132065281
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.