Wearable Health Technology for Perioperative Risk Assessment

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05083598

Acronym

WELCOME

Enrollment

Registered

2021-10-19

Start date

2021-06-10

Completion date

2022-07-30

Last updated

2022-11-30

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

Conditions

Surgery--Complications

Brief summary

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.

Interventions

OTHER6 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.

OTHERFrailty questionaires

Clinical Frailty Score, Metabolic Equivalent of Task, DUKE Activity Status Index

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

70 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026