Wearable Health Technology for Perioperative Risk Assessment (WELCOME)

Accurate and timely preoperative identification of high-risk patients provides opportunities to better inform and manage them. Current predictors for perioperative complications are either resource consuming or have low accuracy. The primary objective of the study is to assess if Wearable Devices may be an alternative to assess cardiopulmonary function, with low risks and lower costs.

Study Overview

• Status: Completed
• Conditions: Surgery--Complications
• Intervention / Treatment: Other: 6 Minute walking test; Other: Frailty questionaires

• Study Type: Observational
• Enrollment (Actual): 31

Contacts and Locations

Study Locations

• Italy
  • Milan
    • Rozzano, Milan, Italy, 20089
      • Humanitas Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients aged 70 or older undergoing major non cardiac surgery, with expected surgical duration > 2 hours.

Description

Inclusion Criteria:

• Age 70 or more
• Undergoing major non cardiac surgery
• Expected surgical duration > 2 hours.

Exclusion Criteria:

• Patients unable to express consent
• Patients undergoing urgent/emergent surgery
• Patients in which surgery is planned within less than two weeks
• Patients with limited physical activity due to limited mobility related with neurological or orthopedic disease
• Acute cardiovascular event
• Surgery conducted in locoregional anesthesia only

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Adult patients undergoing major surgery; Patients aged 70 or older undergoing major non cardiac surgery, with expected surgical duration > 2 hours.

Other: 6 Minute walking test; The patient is asked to repetitively walk along a 15 m track, at their best speed, in six minutes. Before and after the exercise, blood arterial pressure and dyspnea level (via Borg scale) are assessed. Cardiac frequency and peripheral Oxygen saturation are assessed before the test, and every minute and in the two minutes following the exercise.; Other: Frailty questionaires; Clinical Frailty Score, Metabolic Equivalent of Task, DUKE Activity Status Index

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Assess whether wearable devices (WD) can identify patients at risk for postoperative complications.	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
To compare performance of WD data with 6MWT, MET scale, CFS and ASA score in identifying reduced functional capacity	24 months
A sub analysis of WD data during 6MWT will be conducted	24 months

Collaborators and Investigators

• Sponsor: Istituto Clinico Humanitas
• Collaborators: Politecnico di Milano

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 10, 2021
• Primary Completion (ACTUAL): June 30, 2022
• Study Completion (ACTUAL): July 30, 2022

Study Registration Dates

• First Submitted: October 7, 2021
• First Submitted That Met QC Criteria: October 7, 2021
• First Posted (ACTUAL): October 19, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 30, 2022
• Last Update Submitted That Met QC Criteria: November 25, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 2881

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No