Utilizing Technology for Optimization of Pain Management and Mobilization in High Risk Cardiac Surgical ICU Patients
NCT ID: NCT04146727
Last Updated: 2019-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
168 participants
OBSERVATIONAL
2020-01-31
2021-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ICU Duration
The total study duration is determined by their length of stay in the ICU.
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cedars-Sinai Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Anahat Dhillon
Staff Physician II
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Anahat Dhillon, MD
Role: PRINCIPAL_INVESTIGATOR
Cedars-Sinai Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cedars-Sinai Medical Center
Los Angeles, California, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Anahat Dhillion, MD
Role: primary
Tracey S Early, BS, MA
Role: backup
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
pro000578722
Identifier Type: -
Identifier Source: org_study_id