Wearable Health Technology for Perioperative Risk Assessment

Surgery--Complications Clinical Trial

— WELCOME  

Official title:

Wearable Health Technology for Perioperative Risk Assessment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05083598
• Other study ID #: 2881
• Status: Completed
• Start date: June 10, 2021
• Est. completion date: July 30, 2022

Study information

• Verified date: November 2022
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: July 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Surgery--Complications

Intervention

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

Locations

Country	Name	City	State
Italy	Humanitas Research Hospital	Rozzano	Milan

Sponsors (2)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas	Politecnico di Milano

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess whether wearable devices (WD) can identify patients at risk for postoperative complications.		12 months
Secondary	To compare performance of WD data with 6MWT, MET scale, CFS and ASA score in identifying reduced functional capacity		24 months
Secondary	A sub analysis of WD data during 6MWT will be conducted		24 months