Surgery Clinical Trial
— REMOTESOfficial title:
REmote Monitoring for preOperaTive Risk assEssment for Major Abdominal Surgery
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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | October 1, 2024 |
Est. primary completion date | June 19, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Leeds Teaching Hospitals | Leeds |
Lead Sponsor | Collaborator |
---|---|
University of Leeds | The Leeds Teaching Hospitals NHS Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recruitment rates | Ratio of patients recruited in the study to overall number of eligible patients approached | up to 18 months | |
Primary | Utility as measured by the System Usability Questionnaires. | Will be assessed with System Usability score questionnaires filled by participants | up to 18 months | |
Secondary | Acceptability of the Remote monitoring system as evidenced by qualitative interviews. | Patients are invited to take part in an interview process if they are willing to elaborate and provide their thoughts and experiences on the system.
In addition all patients fill in specific questionnaire regarding their experience of the remote monitoring system at the end of the monitoring process. |
up to 18 months | |
Secondary | Number of Predictors extracted from the wearable data. | Feature extraction and machine learning analysis of the wearable raw data will determine which predictors might be significant during the development of a predictive model process. (Such predictors might include factors such as Heart rate, Heart rate variability, Heart rate reserve, foot step count, walking distance, walking speed, respiratory rate). | up to 21 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05583916 -
Same Day Discharge for Video-Assisted Thoracoscopic Surgery (VATS) Lung Surgery
|
N/A | |
Completed |
NCT04448041 -
CRANE Feasibility Study: Nutritional Intervention for Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries
|
||
Completed |
NCT03213314 -
HepaT1ca: Quantifying Liver Health in Surgical Candidates for Liver Malignancies
|
N/A | |
Enrolling by invitation |
NCT05534490 -
Surgery and Functionality in Older Adults
|
N/A | |
Recruiting |
NCT04792983 -
Cognition and the Immunology of Postoperative Outcomes
|
||
Terminated |
NCT04612491 -
Pre-operative Consultation on Patient Anxiety and First-time Mohs Micrographic Surgery
|
||
Recruiting |
NCT06397287 -
PROM Project Urology
|
||
Recruiting |
NCT04444544 -
Quality of Life and High-Risk Abdominal Cancer Surgery
|
||
Completed |
NCT04204785 -
Noise in the OR at Induction: Patient and Anesthesiologists Perceptions
|
N/A | |
Completed |
NCT03432429 -
Real Time Tissue Characterisation Using Mass Spectrometry REI-EXCISE iKnife Study
|
||
Completed |
NCT04176822 -
Designing Animated Movie for Preoperative Period
|
N/A | |
Recruiting |
NCT05370404 -
Prescribing vs. Recommending Over-The-Counter (PROTECT) Analgesics for Patients With Postoperative Pain:
|
N/A | |
Not yet recruiting |
NCT05467319 -
Ferric Derisomaltose/Iron Isomaltoside and Outcomes in the Recovery of Gynecologic Oncology ERAS
|
Phase 3 | |
Recruiting |
NCT04602429 -
Children's Acute Surgical Abdomen Programme
|
||
Completed |
NCT03124901 -
Accuracy of Noninvasive Pulse Oximeter Measurement of Hemoglobin for Rainbow DCI Sensor
|
N/A | |
Completed |
NCT04595695 -
The Effect of Clear Masks in Improving Patient Relationships
|
N/A | |
Recruiting |
NCT06103136 -
Maestro 1.0 Post-Market Registry
|
||
Completed |
NCT05346588 -
THRIVE Feasibility Trial
|
Phase 3 | |
Completed |
NCT04059328 -
Novel Surgical Checklists for Gynecologic Laparoscopy in Haiti
|
||
Recruiting |
NCT03697278 -
Monitoring Postoperative Patient-controlled Analgesia (PCA)
|
N/A |