- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03328039
uSing Wearable TEchnology to Predict Perioperative High-riSk Patient Outcomes (STEPS)
May 17, 2019 updated by: Cardiff University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
47
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Cardiff, United Kingdom, CF14 4XW
- University Hospital of Wales
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Successful recoding of accelerometer data
Time Frame: 7 days
|
Successful recoding of accelerometer data
|
7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Matt Morgan, PhD, Cardiff University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2017
Primary Completion (Actual)
January 1, 2019
Study Completion (Actual)
January 1, 2019
Study Registration Dates
First Submitted
December 8, 2016
First Submitted That Met QC Criteria
October 27, 2017
First Posted (Actual)
November 1, 2017
Study Record Updates
Last Update Posted (Actual)
May 20, 2019
Last Update Submitted That Met QC Criteria
May 17, 2019
Last Verified
February 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- SPON1571-16
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
Only on request.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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