uSing Wearable TEchnology to Predict Perioperative High-riSk Patient Outcomes
STEPS
1 other identifier
observational
47
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 8, 2016
CompletedStudy Start
First participant enrolled
February 1, 2017
CompletedFirst Posted
Study publicly available on registry
November 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2019
CompletedMay 20, 2019
February 1, 2018
1.9 years
December 8, 2016
May 17, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Successful recoding of accelerometer data
Successful recoding of accelerometer data
7 days
Interventions
Physiological data capture only
Eligibility Criteria
Recently, low-cost, wearable activity monitors have become very popular. They can record lots of information about a person's general health and activity. In this study, we would like to see if an activity monitor can help predict a person's risk of developing complications after having major surgery.
You may qualify if:
- Aged 18 years or older with capacity to consent
- Clinical indications for planned CPET testing before planned major elective surgery
You may not qualify if:
- Atrial fibrillation
- Nickel allergy
- Unable to wear a watch
- Unable to conduct CPET
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cardiff Universitylead
- Cardiff and Vale University Health Boardcollaborator
Study Sites (1)
University Hospital of Wales
Cardiff, CF14 4XW, United Kingdom
Related Publications (1)
Jones L, Tan L, Carey-Jones S, Riddell N, Davies R, Brownsdon A, Kelson M, Williams-Thomas R, Busse M, Davies MM, Morgan MPG. Can wearable technology be used to approximate cardiopulmonary exercise testing metrics? Perioper Med (Lond). 2021 Mar 16;10(1):9. doi: 10.1186/s13741-021-00180-w.
PMID: 33722305DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Matt Morgan, PhD
Cardiff University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 8, 2016
First Posted
November 1, 2017
Study Start
February 1, 2017
Primary Completion
January 1, 2019
Study Completion
January 1, 2019
Last Updated
May 20, 2019
Record last verified: 2018-02
Data Sharing
- IPD Sharing
- Will share
Only on request.