Cardiac Surgery Sternal Precautions

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05206929
• Other study ID #: IRB20-1339
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: June 2025

Study information

• Verified date: March 2024
• Source: University of Chicago
• Contact: Carlisa Dixon
• Phone: 773-834-4337
• Email: cdixon520[@]bsd.uchicago.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: June 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Valve Disease
• Heart Diseases
• Heart Failure
• Heart Valve Diseases
• Surgery

Intervention

Other:
• Self Managed Care
Self Managed Care

Locations

Country	Name	City	State
United States	The University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sternal Precaution Checklist	Assessing patients' adherence to protocol	Patient will be called weekly for 8 weeks by a medical professional.
Secondary	Sternal Precautions- Quality of Life Questions	Assessing patients' postoperative quality of life	Patient will be called weekly for 8 weeks by a medical professional.
Secondary	Sternal Precaution Pain Scale	Assessing patients' postoperative pain	Patient will be called weekly for 8 weeks by a medical professional.