Wearable Health Technology for Perioperative Risk Assessment

NCT05083598 | Completed

• 1 other identifier: 2881
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery--Complications

Outcome Measures

Primary Outcomes (1)

• Assess whether wearable devices (WD) can identify patients at risk for postoperative complications.

  12 months

Secondary Outcomes (2)

• 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

Study Arms (1)

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; Other: Frailty questionaires

Interventions

6 Minute walking test OTHER

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.

Adult patients undergoing major surgery

Frailty questionaires OTHER

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

Adult patients undergoing major surgery

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead
• Politecnico di Milano: collaborator

Study Sites (1)

Humanitas Research Hospital

Rozzano, Milan, 20089, Italy

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2021
• First Posted: October 19, 2021
• Study Start: June 10, 2021
• Primary Completion: June 30, 2022
• Study Completion: July 30, 2022
• Last Updated: November 30, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)