Wearable Health Technology for Perioperative Risk Assessment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

31 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-10

Study Completion Date

2022-07-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

PREhabilitation of Frail Elderly PAtients Undergoing majoR surgEry at HOME (PREPARE-HOME) Using Smart Wearables

NCT06633614

Frailty Syndrome

NOT_YET_RECRUITING NA

Application of Wearable Technology in High-risk Surgical Patients in the Perioperative Period

NCT05642988

Adult ALL Surgery Anesthesia +1 more

COMPLETED

Wearable Devices Empowering Active Health Initiatives for High-Risk Stroke Populations

NCT06935513

Hypertension Diabetes Atrial Fibrillation +4 more

RECRUITING NA

uSing Wearable TEchnology to Predict Perioperative High-riSk Patient Outcomes

NCT03328039

Perioperative Care

COMPLETED

Using Fitbit to Monitor Ambulation in Patients After Surgery.

NCT02741895

General Surgery

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Surgery--Complications

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Adult patients undergoing major surgery

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

6 Minute walking test

Intervention Type 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

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Frailty questionaires

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No