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OpenTrials
Completed

NCT Number: NCT03328039

uSing Wearable TEchnology to Predict Perioperative High-riSk Patient Outcomes

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.

Completed

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Key information

Conditions

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Wales

Cardiff, CF14 4XW, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Garmin wearable device

Device

Physiological data capture only

Primary outcomes

  1. Successful recoding of accelerometer data

    Time frame: 7 days

    Successful recoding of accelerometer data

Sponsors and collaborators

Lead sponsor

Cardiff University

Other

Collaborators

  • Cardiff and Vale University Health Board

Registry information

Acronym: STEPS

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 1, 2017
Registry last updated
May 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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