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

NCT04146727 | Unknown

• 1 other identifier: pro000578722
• Study Type: observational
• Target: 168
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Transplant; Failure, Heart; Heart Failure, Congestive; Lung Transplant Failure

Outcome Measures

Primary Outcomes (3)

• Daily ambulation

  Steps taken

  From date of inclusion until discharge from hospital assessed up to 30 days post enrollment

• Length of Stay

  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

  Readmissions to an ICU or hospital

  From date of inclusion until event or 30 days post enrollment

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients that are at high-risk patients for one of the following interventions, will be considered for this study:
• Axillary impella patients awaiting transplant, advanced MCS therapy or weaning
• MCS patients post procedure including TAH, LVADs
• Lung Transplant patients
• Subjects \> 18 years of age.
• Ability to provide informed consent and follow-up with protocol procedures

You may not qualify if:

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

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Anahat Dhillon, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anahat Dhillion, MD

CONTACT

3104233300; Anahat.Dhillon@cshs.org

Tracey S Early, BS, MA

CONTACT

3104231231; tracey.early@cshs.org

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician II

Study Record Dates

• First Submitted: October 24, 2019
• First Posted: October 31, 2019
• Study Start: January 1, 2020
• Primary Completion: January 1, 2021
• Study Completion: June 1, 2021
• Last Updated: October 31, 2019

Record last verified: 2019-10

Locations

US (1)