ALgorithms Adapted From Remote Monitoring (ALARM)

March 21, 2024 updated by: Janani S. Reisenauer, Mayo Clinic
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic in Rochester
        • Contact:
        • Principal Investigator:
          • Janani Reisenauer, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subjects undergoing surgery in the Mayo Clinic Rochester Department of Surgery.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Mayo Clinic Rochester Surgical Patients
Mayo Clinic Watch Device
Device: Mayo Clinic Watch Device
Mayo Clinic remote monitoring platform (Omni) that utilizes a wearable device with integrated physiological monitoring capabilities.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Compliance of Remote Monitoring
Time Frame: 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.
Pre-operative to 15 days post discharge.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of Compensatory Reserve Algorithm
Time Frame: 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.
Pre-operative to 15 days post discharge.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Janani Reisenauer, MD, Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2023

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

February 24, 2023

First Submitted That Met QC Criteria

March 13, 2023

First Posted (Actual)

March 23, 2023

Study Record Updates

Last Update Posted (Actual)

March 22, 2024

Last Update Submitted That Met QC Criteria

March 21, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 22-003308

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Surgery

Clinical Trials on Mayo Clinic Watch Device

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe