Utilizing Technology for Optimization of Pain Management and Mobilization in High Risk Cardiac Surgical ICU Patients

October 30, 2019 updated by: Anahat Dhillon, Cedars-Sinai Medical Center

The purpose of this project is to improve mobility in the perioperative period using activity trackers to augment current practice.

Delirium and poor functional status following ICU stays are intractable problems for which clear solutions do not exist. Digital health approaches have not been applied to these problems in the ICU setting and may represent a viable and unexplored intervention.

The program will involve the utilization of an activity tracker in ambulating patients. There will be two arms to the program. The first will involve the longitudinal study of ambulating lung transplant patients. Patients will be given an activity tracker at time of transplant which will continue throughout their care into their first month at home. The data will be collected to identify correlation between activity and clinical outcomes.

Study Overview

Detailed Description

Early mobilization of patients, minimizing sedatives, maximizing pain control, optimizing sleep are strongly associated with decreased rates of delirium, decreased ICU length of stay, decreased hospital length of stay as well as improved functional status and quality of life at 1 year. Cardiac surgical patients that are at high risk of prolonged stay in the ICU due to the inherent nature of their disease (ie need for MCS (mechanical circulatory support) or lung transplantation) are most likely to benefit from a systematic aggressive approach to early mobilization. Technology such as activity trackers and virtual reality have been studied in general surgical populations but with limited data in the ICU and to date no studies in a cardiac surgical population. Activity trackers utilized in a multidisciplinary team to provide objective data to care teams and patients can be used to develop goal setting and patient motivation for teams, thereby improving mobility

Overall Goal: To evaluate whether quantitative information on post procedural ambulation in mechanical device patients, cardiac surgical patients and lung transplant patients can improve care teams ability to monitor and identify patients at high risk for complications and prolonged length of stay.

  • The purpose of the research is to improve mobility in the perioperative period using Activity Trackers to augment current practice.
  • Objective quantification and improvement in activity of post cardiac surgery patients might result in improved clinical outcomes, thereby making this tool a part of routine practice.

Patient Populations:

  1. Lung transplant patients
  2. Routine postoperative Cardiac surgical patients (elective cardiac surgical procedures including CABG and Valve replacement)
  3. Device Patients (axillary patients pre-open heart transplantation (OHT). Post MCS patients)

Specific Aim 1: Create standardized trajectories for ambulation of study subject populations from time of index procedure to 30 days postoperatively Specific Aim 2: To determine if deviation from the standardized trajectory of postoperative ambulation predicts disposition (home, rehabilitation facility or SNF), length of stay, 30 day readmissions, intensive care unit (ICU) readmission, DVT, respiratory insufficiency (aspiration) Specific Aim 3: To determine if decline in ambulation over 48 hours for a given patient predicts outcomes including length of stay, readmission to an icu, readmission to hospital, deep vein thrombosis (DVT), respiratory insufficiency.

The purpose of this project is to improve mobility in the perioperative period using activity trackers to augment current practice.

Delirium and poor functional status following ICU stays are intractable problems for which clear solutions do not exist. Digital health approaches have not been applied to these problems in the ICU setting and may represent a viable and unexplored intervention.

The program will involve the utilization of an activity tracker in ambulating patients. There will be two arms to the program. The first will involve the longitudinal study of ambulating lung transplant patients. Patients will be given an activity tracker at time of transplant which will continue throughout their care into their first month at home. The data will be collected to identify correlation between activity and clinical outcomes.

The second part of the program will be within the intensive care unit. The daily step count will be recorded for all ambulatory patients that fall into one of the defined subject populations and have signed informed consent. Step counts will be displayed for the care teams as well as the patient. This will be utilized by team to continuously evaluate and modify physical mobility goals for the patient with earlier recognition of decreasing mobility which is associated with worse outcomes. The goals and progress for the patient will be displayed to the nursing staff and the patient which we hypothesize will increase motivation.

Our hypothesis is that these interventions will increase mobility, decrease ICU length of stay, optimize the ICU experience, and potentially increase in 6-month functional status.

Study Type

Observational

Enrollment (Anticipated)

168

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 Contact Backup

Study Locations

    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Dominic Emerson, MD
        • Sub-Investigator:
          • Michael Nurok, 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

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Investigators and co-investigators will approach eligible subjects about the study in person after identification of patients in the intensive care unit or prior to surgery if it is not an emergent surgery. Some of the patients will be patients of other surgeons and intensivists who are part of the team-based care of these cardiac surgical patients.

Description

Inclusion Criteria:

Patients that are at high-risk patients for one of the following interventions, will be considered for this study:

  1. Axillary impella patients awaiting transplant, advanced MCS therapy or weaning
  2. MCS patients post procedure including TAH, LVADs
  3. Lung Transplant patients
  4. Subjects > 18 years of age.
  5. Ability to provide informed consent and follow-up with protocol procedures

Exclusion Criteria:

  1. Non-ambulatory patients
  2. Participation in an on-going protocol studying an experimental drug or device
  3. Use of a walker, cane or wheelchair at baseline
  4. Inability to wear the biosensor on the wrist
  5. Any condition or other reason that, in the opinion of the Investigator or Medical Monitor, would render the subject unsuitable for the 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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
ICU Duration
The total study duration is determined by their length of stay in the ICU.
Transplant through 1 month at Home
Time from surgery through 1 month at home. Maximum duration is length of stay in the ICU plus 1 month at home.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Daily ambulation
Time Frame: From date of inclusion until discharge from hospital assessed up to 30 days post enrollment
Steps taken
From date of inclusion until discharge from hospital assessed up to 30 days post enrollment
Length of Stay
Time Frame: From date of inclusion until discharge from hospital assessed up to 30 days post enrollment
Days until Discharge to a transitional care facility vs. home
From date of inclusion until discharge from hospital assessed up to 30 days post enrollment
Admit again to ICU
Time Frame: From date of inclusion until event or 30 days post enrollment
Readmissions to an ICU or hospital
From date of inclusion until event or 30 days post enrollment

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Anahat Dhillon, MD, Cedars-Sinai Medical Center

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 (Anticipated)

January 1, 2020

Primary Completion (Anticipated)

January 1, 2021

Study Completion (Anticipated)

June 1, 2021

Study Registration Dates

First Submitted

October 24, 2019

First Submitted That Met QC Criteria

October 30, 2019

First Posted (Actual)

October 31, 2019

Study Record Updates

Last Update Posted (Actual)

October 31, 2019

Last Update Submitted That Met QC Criteria

October 30, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • pro000578722

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 Transplant; Failure, Heart

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