Median Sternotomy in Penetrating Cardiac Trauma
Primary Purpose
Trauma Chest
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
median sternotomy
Sponsored by
About this trial
This is an interventional treatment trial for Trauma Chest
Eligibility Criteria
Inclusion Criteria:
- A. Inclusion criteria:
Penetrating traumatic cardiac patients. B.age:patients aged from15 to 60 years old.
Exclusion Criteria:
- Patient who arrest immediately when arrived trauma unit.
- patients with polytrauma
- patients with chronic medical disease as asthma or ischemic herat disease
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
median sternotomy
Arm Description
median sternotomy in penetrating cardiac trauma and hemodynamically unstable patients, does it affect morbidity and mortality.
Outcomes
Primary Outcome Measures
Time needed to explore heart
To reveal time needed to explore heart in both interventions.
Secondary Outcome Measures
Pain by pain score
Post operative pain complained by patient.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04917198
Brief Title
Median Sternotomy in Penetrating Cardiac Trauma
Official Title
Median Sternotomy in Penetrating Cardiac Trauma Does it Make a Difference?
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 21, 2021 (Anticipated)
Primary Completion Date
September 1, 2022 (Anticipated)
Study Completion Date
October 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The investigators aim to assess role of median sternotomy in penetrating cardiac trauma regarding morbidity and mortality of the patients.
Detailed Description
Cardiac trauma is a leading cause of death in the USA and occurs mostly due to motor vehicle accidents. Cardiac trauma may be blunt or as a penetrating chest injuries, and both can lead to aortic injuries. The Right Ventricle followed by the Left Ventricle was the most common site of injury.
Timely diagnosis and early management are the key to improve mortality. Mortality related to cardiac trauma remains high despite improvement in diagnosis and management.
Assessment of suspected cardiac injuries in a trauma setting is a challenging and time-critical matter, with clinical and imaging findings having complementary roles in the formation of an accurate diagnosis. Cardiac computed tomography and cardiac ultrasound are the two most important diagnostic modalities.
Pericardial tamponade and haemothorax were common intra-operative findings. Patients having penetrating cardiac injury presenting with detectable signs of life on arrival to the hospital can be rescued by early surgical intervention.
Penetrating cardiac injuries are high-risk, high-mortality injuries considering the outcomes. Therefore, it is important to choose the appropriate incision. In general clinical settings, thoracotomy and median sternotomy are choices of incisions to explore the injury.
It is really important to transfer these patients to the nearest facility in time, make sure they get immediate diagnosis and proper resuscitation until they are ready to be taken into the operating room for exploration.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma Chest
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
median sternotomy
Arm Type
Experimental
Arm Description
median sternotomy in penetrating cardiac trauma and hemodynamically unstable patients, does it affect morbidity and mortality.
Intervention Type
Procedure
Intervention Name(s)
median sternotomy
Intervention Description
median sternotomy
Primary Outcome Measure Information:
Title
Time needed to explore heart
Description
To reveal time needed to explore heart in both interventions.
Time Frame
baseline
Secondary Outcome Measure Information:
Title
Pain by pain score
Description
Post operative pain complained by patient.
Time Frame
baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
A. Inclusion criteria:
Penetrating traumatic cardiac patients. B.age:patients aged from15 to 60 years old.
Exclusion Criteria:
Patient who arrest immediately when arrived trauma unit.
patients with polytrauma
patients with chronic medical disease as asthma or ischemic herat disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Gadallah
Phone
+201067172284
Email
ahmedgadallah629@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed Mahmoud
Phone
+201008332462
Email
mohamedmahmoud@aun.edu.org
12. IPD Sharing Statement
Citations:
PubMed Identifier
26802100
Citation
Gosavi S, Tyroch AH, Mukherjee D. Cardiac Trauma. Angiology. 2016 Nov;67(10):896-901. doi: 10.1177/0003319715627954. Epub 2016 Jul 11.
Results Reference
background
PubMed Identifier
28850860
Citation
Leite L, Goncalves L, Nuno Vieira D. Cardiac injuries caused by trauma: Review and case reports. J Forensic Leg Med. 2017 Nov;52:30-34. doi: 10.1016/j.jflm.2017.08.013. Epub 2017 Aug 24.
Results Reference
background
PubMed Identifier
30108408
Citation
Rahim Khan HA, Gilani JA, Pervez MB, Hashmi S, Hasan S. Penetrating cardiac trauma: A retrospective case series from Karachi. J Pak Med Assoc. 2018 Aug;68(8):1285-1287.
Results Reference
background
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Median Sternotomy in Penetrating Cardiac Trauma
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