uSing Wearable TEchnology to Predict Perioperative High-riSk Patient Outcomes

NCT ID: NCT03328039

Last Updated: 2019-05-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 47 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-02-01
• Study Completion Date: 2019-01-01

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.

Conditions

Perioperative Care

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Garmin wearable device

Physiological data capture only

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cardiff and Vale University Health Board

OTHER_GOV

Sponsor Role: collaborator

Cardiff University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matt Morgan, PhD

Role: PRINCIPAL_INVESTIGATOR

Cardiff University

Locations

University Hospital of Wales

Cardiff, , United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 33722305 (View on PubMed)

Other Identifiers

SPON1571-16

Identifier Type: -

Identifier Source: org_study_id