Cardiac Surgery Sternal Precautions

Sponsor

University of Chicago (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05206929

Collaborator

(none)

Enrollment

Location

Arms

12.1

Anticipated Duration (Months)

5.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Surgery Heart Diseases Heart Failure Cardiac Valve Disease	Other: Self Managed Care	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

64 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

1:1 randomization1:1 randomization

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2022

Anticipated Primary Completion Date :

Jan 3, 2023

Anticipated Study Completion Date :

Jun 3, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Sternal Precaution Checklist [Patient will be called weekly for 8 weeks by a medical professional.]
Assessing patients' adherence to protocol

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Chicago	Chicago	Illinois	United States	60637

Sponsors and Collaborators

University of Chicago

Investigators

Principal Investigator: Valluvan Jeevanandam, MD, Professor of Surgery

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Chicago

ClinicalTrials.gov Identifier:

NCT05206929

Other Study ID Numbers:

IRB20-1339

First Posted:

Jan 25, 2022

Last Update Posted:

Apr 28, 2022

Last Verified:

Apr 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Heart Diseases

Heart Valve Diseases

Study Results

No Results Posted as of Apr 28, 2022