ALgorithms Adapted From Remote Monitoring

Surgery Clinical Trial

— ALARM  

Official title:

ALgorithms Adapted From Remote Monitoring

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05782140
• Other study ID #: 22-003308
• Status: Recruiting
• Start date: February 20, 2023
• Est. completion date: July 2024

Study information

• Verified date: March 2024
• Source: Mayo Clinic
• Contact: Karlyn Pierson, MAN, RN
• Phone: 507-538-1960
• Email: pierson.akrlyn[@]mayo.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

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.

Related Conditions & MeSH terms

• Surgery

Intervention

Device:
• Mayo Clinic Watch Device
Mayo Clinic remote monitoring platform (Omni) that utilizes a wearable device with integrated physiological monitoring capabilities.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Compliance of Remote Monitoring	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.	Pre-operative to 15 days post discharge.
Secondary	Correlation of Compensatory Reserve Algorithm	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.	Pre-operative to 15 days post discharge.