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uSing Wearable TEchnology to Predict Perioperative High-riSk Patient Outcomes

uSing Wearable TEchnology to Predict Perioperative High-riSk Patient Outcomes

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03328039
Acronym
STEPS
Enrollment
47
Registered
2017-11-01
Start date
2017-02-01
Completion date
2019-01-01
Last updated
2019-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perioperative Care

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.

Interventions

DEVICEGarmin wearable device

Physiological data capture only

Sponsors

Cardiff and Vale University Health Board
CollaboratorOTHER_GOV
Cardiff University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Successful recoding of accelerometer data7 daysSuccessful recoding of accelerometer data

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026