Back to resultsCardiac Surgery Sternal Precautions
Primary Purpose
Surgery, Heart Diseases, Heart Failure
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Self Managed Care
Sponsored by
About this trial
This is an interventional other trial for Surgery
Eligibility Criteria
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
Sites / Locations
- The University of Chicago
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Arm 1
Arm 2
Arm Description
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.
Arm 2 will receive the standard sternal precautions at time of post operative discharge.
Outcomes
Primary Outcome Measures
Sternal Precaution Checklist
Assessing patients' adherence to protocol
Secondary Outcome Measures
Sternal Precautions- Quality of Life Questions
Assessing patients' postoperative quality of life
Sternal Precaution Pain Scale
Assessing patients' postoperative pain
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05206929
Brief Title
Cardiac Surgery Sternal Precautions
Official Title
A Randomized Trial of Standard of Care Sternal Precautions VS Self Managed Care
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2022 (Anticipated)
Primary Completion Date
January 3, 2023 (Anticipated)
Study Completion Date
June 3, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgery, Heart Diseases, Heart Failure, Cardiac Valve Disease
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
1:1 randomization
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm 2
Arm Type
Active Comparator
Arm Description
Arm 2 will receive the standard sternal precautions at time of post operative discharge.
Intervention Type
Other
Intervention Name(s)
Self Managed Care
Intervention Description
Self Managed Care
Primary Outcome Measure Information:
Title
Sternal Precaution Checklist
Description
Assessing patients' adherence to protocol
Time Frame
Patient will be called weekly for 8 weeks by a medical professional.
Secondary Outcome Measure Information:
Title
Sternal Precautions- Quality of Life Questions
Description
Assessing patients' postoperative quality of life
Time Frame
Patient will be called weekly for 8 weeks by a medical professional.
Title
Sternal Precaution Pain Scale
Description
Assessing patients' postoperative pain
Time Frame
Patient will be called weekly for 8 weeks by a medical professional.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Rodgers
Phone
7737025383
Email
drodgers3@bsd.uchicago.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valluvan Jeevanandam, MD
Organizational Affiliation
Professor of Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Rodgers
Phone
773-834-5572
Email
drodgers3@medicine.bsd.uchicago.edu
First Name & Middle Initial & Last Name & Degree
Valluvan Jeevanandam, MD
12. IPD Sharing Statement
Learn more about this trial
Cardiac Surgery Sternal Precautions
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