Utilizing Technology for Optimization of Pain Management and Mobilization in High Risk Cardiac Surgical ICU Patients
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Cedars-Sinai Medical Center
- Enrollment
- 168
- Locations
- 1
- Primary Endpoint
- Daily ambulation
Study Overview
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.
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:
- Lung transplant patients
- Routine postoperative Cardiac surgical patients (elective cardiac surgical procedures including CABG and Valve replacement)
- Device Patients (axillary patients pre-open heart transplantation (OHT). Post MCS patients)
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Daily ambulation
Time Frame: From date of inclusion until discharge from hospital assessed up to 30 days post enrollment
Steps taken
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
Admit again to ICU
Time Frame: From date of inclusion until event or 30 days post enrollment
Readmissions to an ICU or hospital
Secondary Outcomes
No secondary outcomes reported
Investigators
Anahat Dhillon
Staff Physician II
Cedars-Sinai Medical Center