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Clinical Trials/NCT03328039
NCT03328039
Completed
Not Applicable

uSing Wearable TEchnology to Predict Perioperative High-riSk Patient Outcomes

Cardiff University1 site in 1 country47 target enrollmentFebruary 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Perioperative Care
Sponsor
Cardiff University
Enrollment
47
Locations
1
Primary Endpoint
Successful recoding of accelerometer data
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

This is an observational, non-interventional study to assess the equivalence of wearable monitors with formal CPET testing for the prediction of physiological reserve before major surgery.

Detailed Description

This project will exploit the rapid development of wearable technology to allow perioperative risk prediction to become logistically easier, cost effective and used more broadly. It will use low cost wearable technology to complement or act as a surrogate to complex CPET testing performed for perioperative risk stratification. The data gained from a Garmin Vivosmart HR+ wearable device, will be used in the community by patients awaiting surgery, and will be correlated with key CPET indices including anaerobic threshold and peak VO2. Ultimately, this study aims to assess whether wearable technology can provide the data needed for the formation of prediction models to risk assess perioperative outcomes in patients undergoing high-risk elective surgery. In addition, an International Physical Activity Questionnaire (IPAQ) will be completed to compare the activity captured with self-reported activity. This will be combined with frailty scores and handgrip strength as is routinely collected during CPET. Finally, a saliva based genetic analysis will be conducted on genetic variations known to be of significance in critical illness and response to physical stress. This will be delivered by a laboratory (Fitness Genes) that has developed a bespoke panel of genetic markers ideally suited to this patient cohort.

Registry
clinicaltrials.gov
Start Date
February 1, 2017
End Date
January 1, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Aged 18 years or older with capacity to consent
  • Clinical indications for planned CPET testing before planned major elective surgery

Exclusion Criteria

  • Atrial fibrillation
  • Nickel allergy
  • Unable to wear a watch
  • Unable to conduct CPET
  • Pregnancy

Outcomes

Primary Outcomes

Successful recoding of accelerometer data

Time Frame: 7 days

Successful recoding of accelerometer data

Study Sites (1)

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