Median Sternotomy in Penetrating Cardiac Trauma

Trauma Chest Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04917198
• Other study ID #: Median sternotomy
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 21, 2021
• Est. completion date: October 1, 2022

Study information

• Verified date: June 2021
• Source: Assiut University
• Contact: Ahmed Gadallah
• Phone: +201067172284
• Email: ahmedgadallah629[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: October 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Trauma Chest
• Wounds and Injuries

Intervention

Procedure:
• median sternotomy
median sternotomy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (3)

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

Leite L, Gonçalves 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time needed to explore heart	To reveal time needed to explore heart in both interventions.	baseline
Secondary	Pain by pain score	Post operative pain complained by patient.	baseline