Median Sternotomy in Penetrating Cardiac Trauma

Median Sternotomy in Penetrating Cardiac Trauma Does it Make a Difference?

The investigators aim to assess role of median sternotomy in penetrating cardiac trauma regarding morbidity and mortality of the patients.

Study Overview

• Status: Not yet recruiting
• Conditions: Trauma Chest
• Intervention / Treatment: Procedure: median sternotomy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed Gadallah; Phone Number: +201067172284; Email: ahmedgadallah629@gmail.com
• Study Contact Backup: Name: Mohamed Mahmoud; Phone Number: +201008332462; Email: mohamedmahmoud@aun.edu.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: median sternotomy; median sternotomy in penetrating cardiac trauma and hemodynamically unstable patients, does it affect morbidity and mortality.	Procedure: median sternotomy; median sternotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time needed to explore heart	To reveal time needed to explore heart in both interventions.	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain by pain score	Post operative pain complained by patient.	baseline

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• Gosavi S, Tyroch AH, Mukherjee D. Cardiac Trauma. Angiology. 2016 Nov;67(10):896-901. doi: 10.1177/0003319715627954. Epub 2016 Jul 11.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): December 21, 2021
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: May 20, 2021
• First Submitted That Met QC Criteria: June 1, 2021
• First Posted (Actual): June 8, 2021

Study Record Updates

• Last Update Posted (Actual): June 8, 2021
• Last Update Submitted That Met QC Criteria: June 1, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: Median sternotomy

Drug and device information, study documents

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