Wearable Health Technology for Perioperative Risk Assessment
Completed
- Conditions
- Surgery--Complications
- Interventions
- Other: 6 Minute walking testOther: Frailty questionaires
- Registration Number
- NCT05083598
- Lead Sponsor
- Istituto Clinico Humanitas
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 31
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Adult patients undergoing major surgery Frailty questionaires Patients aged 70 or older undergoing major non cardiac surgery, with expected surgical duration \> 2 hours. Adult patients undergoing major surgery 6 Minute walking test Patients aged 70 or older undergoing major non cardiac surgery, with expected surgical duration \> 2 hours.
- Primary Outcome Measures
Name Time Method Assess whether wearable devices (WD) can identify patients at risk for postoperative complications. 12 months
- Secondary Outcome Measures
Name Time Method A sub analysis of WD data during 6MWT will be conducted 24 months To compare performance of WD data with 6MWT, MET scale, CFS and ASA score in identifying reduced functional capacity 24 months
Trial Locations
- Locations (1)
Humanitas Research Hospital
🇮🇹Rozzano, Milan, Italy