WELCOME: Wearable Health Technology for Perioperative Risk Assessment

• Sponsor: Istituto Clinico Humanitas (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05083598
• Collaborator: Politecnico di Milano (Other)
• Enrollment: 40
• Location: 1
• Anticipated Duration (Months): 12.6
• Patients Per Site Per Month: 3.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Surgery--Complications	Other: 6 Minute walking test; Other: Frailty questionaires

Study Design

• Study Type: Observational
• Anticipated Enrollment: 40 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Wearable Health Technology for Perioperative Risk Assessment
• Actual Study Start Date: Jun 10, 2021
• Anticipated Primary Completion Date: May 31, 2022
• Anticipated Study Completion Date: Jun 30, 2022

Arms and Interventions

Arm

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

Outcome Measures

Primary Outcome Measures

1. Assess whether wearable devices (WD) can identify patients at risk for postoperative complications. [12 months]

Secondary Outcome Measures

1. Develop a scale for prediction of postoperative complications using data from WD. [24 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 70 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Humanitas Research Hospital	Rozzano	Milan	Italy	20089

Sponsors and Collaborators

• Istituto Clinico Humanitas
• Politecnico di Milano

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Istituto Clinico Humanitas
• ClinicalTrials.gov Identifier: NCT05083598
• Other Study ID Numbers: 2881
• First Posted: Oct 19, 2021
• Last Update Posted: May 4, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of May 4, 2022