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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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trauma Chest

Eligibility Criteria

15 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    May 20, 2021
    Last Updated
    June 1, 2021
    Sponsor
    Assiut University
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    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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