Cardiac Surgery Sternal Precautions

A Randomized Trial of Standard of Care Sternal Precautions VS Self Managed Care

Our study aims to compare postoperative outcomes, postoperative pain and postoperative quality of lives in patients who receive the standard sternal precautions to those in patients who received self-managed sternal precautions following sternotomy for cardiac surgeries. The purpose of the study is to see if self-managed sternal precautions following sternotomy for cardiac surgeries lead to better quality of lives while maintaining same postoperative pain and rate of postoperative adverse events than standard sternal precautions. Postoperative pain and postoperative quality of lives will be assessed by phone call surveys. Postoperative outcomes will be measured by following the patients for up to a year using electronic medical record.

Study Overview

• Status: Recruiting
• Conditions: Heart Diseases; Heart Failure; Surgery; Cardiac Valve Disease
• Intervention / Treatment: Other: Self Managed Care

Detailed Description

Patients who are recruited in this study will be randomized (1:1) into one of two groups/arms. The ?rst arm (Arm 1) will receive instruction to use pain and discomfort as the safe limits for their upper limb use during daily activities at post operative discharge. The second arm (Arm 2) will receive the standard sternal precautions at time of post operative discharge. Standard sternal precautions in study arm (2) include:

Don't reach both arms overhead Don't reach both arms out to the side Don't reach behind your back Don't lift more than 5 to 8 pounds Don't push with your arms Don't pull with your arms Don't drive

Each arm will receive weekly phone calls for 8 weeks. Information including pain, quality of life, and adherence to the sternal precaution protocol will be collected. Please refer to supporting documents (Pain Scale, Quality of Life Questionnaire, and Sternal Precaution Checklist) for the specific questions that will be asked at the patients. We will also investigate any adverse events related to the medical care.

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carlisa Dixon; Phone Number: 773-834-4337; Email: cdixon520@bsd.uchicago.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Recruiting
      • The University of Chicago
      • Principal Investigator: Valluvan Jeevanandam, MD
      • Contact: Valluvan Jeevanandam; Phone Number: 773-702-2500; Email: jeevan@bsd.uchicago.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Undergoing a sternotomy, English speaking, 18-70 years old, able to ambulate independently

Exclusion Criteria:

• Sternotomy due to VAD implantation or cardiac transplantation, discharge over 1.5 weeks after surgery, prior sternotomy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1; Arm 1 will receive instruction to use pain and discomfort as the safe limits for their upper limb use during daily activities at post operative discharge.	Other: Self Managed Care; Self Managed Care
Active Comparator: Arm 2; Arm 2 will receive the standard sternal precautions at time of post operative discharge.	Other: Self Managed Care; Self Managed Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sternal Precaution Checklist	Assessing patients' adherence to protocol	Patient will be called weekly for 8 weeks by a medical professional.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sternal Precautions- Quality of Life Questions	Assessing patients' postoperative quality of life	Patient will be called weekly for 8 weeks by a medical professional.
Sternal Precaution Pain Scale	Assessing patients' postoperative pain	Patient will be called weekly for 8 weeks by a medical professional.

Collaborators and Investigators

• Sponsor: University of Chicago
• Investigators: Principal Investigator: Valluvan Jeevanandam, MD, Professor of Surgery

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: January 12, 2022
• First Submitted That Met QC Criteria: January 12, 2022
• First Posted (Actual): January 25, 2022

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases
• Other Study ID Numbers: IRB20-1339

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No