Perioperative Smartwatch Monitoring to Predict Complications

Post-Op Complication Clinical Trial

— PreSmart  

Official title:

Perioperative Smartwatch Monitoring as a Tool to Predict Post-operative Complications in Patients Undergoing Major Abdominal Surgery. A Single Center Prospective Observational Study.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06156033
• Other study ID #: 2023-01186
• Status: Not yet recruiting
• Start date: January 1, 2024
• Est. completion date: August 2024

Study information

• Verified date: December 2023
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: Benoit Henry
• Phone: 0798828587
• Email: benoit.henry[@]chuv.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a prospective, single-center, observational study designed to to quantify complications following major visceral surgery major visceral surgery (such as pancreatic resection or colorectal colorectal surgery), and to identify digital biomarkers (collected pre, and post-operatively by a connected watch) enabling early early identification of patients with post-operative complications. Patients will be invited to wear a watch during the perioperative period, and will receive questionnaires about their their health status.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: August 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Patients will be recruited prospectively for a total of 50 patients.

Inclusion criteria are :

• Patients scheduled for elective major visceral surgery (pancreatic resection or colorectal surgery) under general anesthesia
• 18 years of age or older

Exclusion criteria will be :

• Patient refusal and/or inability to understand and sign informed consent

Related Conditions & MeSH terms

• Post-Op Complication
• Postoperative Complications

Locations

Country	Name	City	State
Switzerland	CHUV	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Vaudois

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comprehensive Complication Index	The primary endpoint was the overall postoperative morbidity following major visceral surgery (such as pancreatic resection or colorectal surgery) as defined by the CCI (Comprehensive Complication Index), which calculates a patient's overall morbidity following surgery based on the Clavien-Dindo classification of complications. The Comprehensive Complication Index (CCI) reflects the severity of this overall burden of complications for the patient on a scale ranging from 0 (no complications) to 100 (death).	J30 post-op