ALgorithms Adapted From Remote Monitoring

Recruiting

• Conditions: Surgery
• Interventions: Device: Mayo Clinic Watch Device

• Registration Number: NCT05782140
• Lead Sponsor: Mayo Clinic

Brief Summary

Through the aid of remote monitoring and early symptom detection, a patient's response to stress and normalization to their individual baseline can better contribute towards algorithms which are predictive of clinical decline.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2023-02-20
• Study First Submitted: 2023-02-24
• Study First Submitted QC: 2023-03-13
• Study First Posted: 2023-03-23
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-22
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• 18 years and older
• Scheduled to undergo surgery resulting in a complex recovery as evaluated by the treating Department of Surgery surgeon. This includes but is not limited to the following inpatient elective surgery procedures: esophagectomy, pancreatectomy, major liver resections, open vascular surgery, lower extremity bypass, colectomy, and complex pulmonary resections (lobes and above).
• Subjects are committed to daily exercise as outlined in the protocol.

Read More

Exclusion Criteria

• <18 years of age
• Subject is pregnant
• Subject is dismissed from the hospital to a nursing home or long term care facility.
• Subject cannot commitment to daily exercise as outlined in the protocol.
• Subjects enrolled in another device or drug study does not necessarily preclude them from participating in this study. Please check with the PI for inclusion if the subject is on another device or drug study.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mayo Clinic Rochester Surgical Patients	Mayo Clinic Watch Device	Mayo Clinic Watch Device

Primary Outcome Measures

Name	Time	Method
Rate of Compliance of Remote Monitoring	Pre-operative to 15 days post discharge.	Determine the feasibility of remote monitoring for preoperative assessment and postoperative follow up by evaluation of rate of compliance of physiological monitoring data and patinet recorded logs.

Secondary Outcome Measures

Name	Time	Method
Correlation of Compensatory Reserve Algorithm	Pre-operative to 15 days post discharge.	Evaluation of compensatory reserve algorithm using collected PPG waveforms by passing the collected waveforms of individuals through the algorithm to determine correlation of its performance particularly related to any events that occur during the postoperative and recovery periods.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States