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OpenTrials
Completed

NCT Number: NCT05083598

Wearable Health Technology for Perioperative Risk Assessment

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.

Completed

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Key information

Conditions

Surgery--Complications

Age range

70 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Humanitas Research Hospital

Rozzano, Milan, 20089, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Frailty questionaires

Other

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

Primary outcomes

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

    Time frame: 12 months

Secondary outcomes

  1. To compare performance of WD data with 6MWT, MET scale, CFS and ASA score in identifying reduced functional capacity

    Time frame: 24 months

  2. A sub analysis of WD data during 6MWT will be conducted

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Istituto Clinico Humanitas

Other

Collaborators

  • Politecnico di Milano

Registry information

Acronym: WELCOME

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 19, 2021
Registry last updated
Nov 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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