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CompletedNCT05083598WELCOMEUpdated Nov 30, 2022

Wearable Health Technology for Perioperative Risk Assessment

An observational study in Surgery--Complications, sponsored by Istituto Clinico Humanitas. Completed at 1 site in Italy. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2022-11-30.

Sponsored by Istituto Clinico Humanitas · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
31
Ages
70 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Surgery--Complications
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In context

Lead sponsor

Istituto Clinico Humanitas is the lead sponsor of 275 studies on the registry; 71 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
70 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
31 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • 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

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What researchers measure

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

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Study locations

1 site
  • Humanitas Research Hospital
    Rozzano, Milan 20089, Italy
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 30, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05083598
Lead sponsor
Istituto Clinico Humanitas
Collaborators
Politecnico di Milano
Responsible party
Sponsor
First posted
Oct 19, 2021
Start date
Jun 10, 2021
Primary completion
Jun 30, 2022
Completion
Jul 30, 2022
Last update
Nov 30, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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