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Emergency Small vs Large Tube Thoracostomy in Chest Trauma Patients.

Primary Purpose

Traumatic Pneumothorax and Hemothorax

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
tube thoracostomy
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Pneumothorax and Hemothorax

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • all chest trauma patients with significant hemothorax, pneumothorax or combined hemo-pneumothorax

Exclusion Criteria:

  • any chest trauma patients undergoing thoracotomy or thoracic surgery for any other reason for example : diaphragmatic tear,flail chest or sternal fracture

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Small sized chest tube

    Large sized chest tube

    Arm Description

    Insertion of small sized chest tube in patients with traumatic hemothorax, pneumothorax or hemopneumothorax.

    insertion of large sized chest tube in patients with traumatic hemothorax, pneumothorax or hemopneumothorax.

    Outcomes

    Primary Outcome Measures

    To compare the number of patients who will have emergent small sized tube thoracostomy and large sized tube thoracostomy regarding the need for another chest tube.
    To compare the number of patients who will have emergent small sized tube thoracostomy and large sized tube thoracostomy regarding the need for another chest tube.

    Secondary Outcome Measures

    Number of trauma patients who will have emergent small vs large thoracostomy tube regarding pain score
    Number of trauma patients who will have emergent small vs large thoracostomy tube regarding pain score
    Number of trauma patients who will have emergent small vs large thoracostomy tube regarding duration of tube insertion.
    Number of trauma patients who will have emergent small vs large thoracostomy tube regarding duration of tube insertion.

    Full Information

    First Posted
    September 17, 2020
    Last Updated
    April 24, 2021
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04863989
    Brief Title
    Emergency Small vs Large Tube Thoracostomy in Chest Trauma Patients.
    Official Title
    Emergency Small vs Large Tube Thoracostomy in Chest Trauma Patients.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2021 (Anticipated)
    Primary Completion Date
    September 2022 (Anticipated)
    Study Completion Date
    December 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
    To compare between small sized tube thoracostomy and large sized tube thoracostomy regarding the need for another chest tube for the fear of obstruction (in hemomothorax) or ineffective drainage (in hemothorax, pneumothorax or hemo-pneumothorax) ,pain score or repositioning and need for thoracotomy.
    Detailed Description
    To evacuate abnormal fluid and air, chest tubes are placed in the pleural space, either surgically or percutaneously. Therapeutic drainage of pleural conditions such as pneumothorax, hemothorax, empyema, chylothorax, and malignant effusions, as well as prophylaxis drainage of air, blood, and other fluids after chest surgery are the indications for chest tubes. Closed water-seal chest drainage has been described in 1875 by Gotthard Bülau to treat an empyema, as an alternative to the standard rib resection and open tube drainage in the acute phase or rib excision (saucerization) in the chronic phase. Bülau emphasized the necessity of negative intrapleural pressure for re-expansion of a collapsed lung in the setting of thoracic empyema although most surgeons in his time attributed deaths from thoracic empyema to infection and not superimposed respiratory compromise due to open pneumothorax . He understood that closed water seal drainage could facilitate lung re-expansion via the patient's natural respiratory movements. Unfortunately, until mechanical ventilation was introduced, application of these principles was limited to the treatment of thoracic empyema. During both the Second World War and the Korean one lung function restoration was the primary goal of thoracic wound treatment: emergency tube thoracostomy became extremely frequent in haemothorax and tension pneumothorax treatment. For the first time the drain was connected to a two-bottle water seal suction system since 1952 , synthetic ones, more flexible and easy to place, replaced metal tubes and modern three chamber thoracic drain, for a more efficient suction, were employed. New, flexible and plastic drains were widely used by the 1980s, they ranged between 6 and 40 French (F) in size. Since it was believed that smaller drains were less effective in adult medicine, being more prone to the risk of obstruction, the smaller ones (≤20 F) were commonly used in children, the bigger in adults,. In the last two decades, small-bore chest tubes (SBCT) have gained increasing popularity In traumatic pneumothorax or hemothorax the optimal tube size for an emergent thoracostomy is unknown. For the nonemergent management of patients with traumatic pneumothorax or hemothorax both small catheter tube thoracostomy and large-bore chest tube thoracostomy have been shown to work. In stable trauma patients small catheter tube thoracostomy is effective and comparable with large catheter tube thoracostomy in managing chest trauma. While the available evidence suggests that in resolving traumatic haemothoraces without additional complications small bore drains may be as effective as large bore drains, there is insufficient evidence currently available to recommend a change to standard practice (ie, large bore drains). Inaba K , et al, 2012 concluded that chest tube size did not impact the clinically relevant outcomes tested for injured patients with chest trauma. There was no difference in the efficacy of drainage, need for additional tube drainage, or invasive procedures and rate of complications including retained hemothorax. Pain felt by patients at the site of insertion was not affected by tube size. Most occurrences of traumatic pneumothorax (PTX) and hemothorax (HTX) can be managed non-operatively by means of chest tube thoracostomy. Although most guidelines for chest trauma recommend a large-bore chest tube, e.g., the 9th edition of the ATLSTM (Advanced Trauma Life Support) program recommends a 36 or 40 Fr tube, and the JATECTM (Japan Advanced Trauma Evaluation and Care) course recommends a 28 Fr or larger tube and choosing the tube size based on the patient's physique, these recommendations are mainly based on traditional clinical habits. These large-bore chest tubes may cause pain related to the insertion site and discomfort, especially in conscious patients. Smaller tubes were reported to reduce the pain associated with the tube insertion site in patients with pleural infection.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Traumatic Pneumothorax and Hemothorax

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Small sized chest tube
    Arm Type
    Experimental
    Arm Description
    Insertion of small sized chest tube in patients with traumatic hemothorax, pneumothorax or hemopneumothorax.
    Arm Title
    Large sized chest tube
    Arm Type
    Active Comparator
    Arm Description
    insertion of large sized chest tube in patients with traumatic hemothorax, pneumothorax or hemopneumothorax.
    Intervention Type
    Procedure
    Intervention Name(s)
    tube thoracostomy
    Intervention Description
    insertion of intercostal tube for drainage of traumatic hemothorax or pneumothorax
    Primary Outcome Measure Information:
    Title
    To compare the number of patients who will have emergent small sized tube thoracostomy and large sized tube thoracostomy regarding the need for another chest tube.
    Description
    To compare the number of patients who will have emergent small sized tube thoracostomy and large sized tube thoracostomy regarding the need for another chest tube.
    Time Frame
    baseline
    Secondary Outcome Measure Information:
    Title
    Number of trauma patients who will have emergent small vs large thoracostomy tube regarding pain score
    Description
    Number of trauma patients who will have emergent small vs large thoracostomy tube regarding pain score
    Time Frame
    baseline
    Title
    Number of trauma patients who will have emergent small vs large thoracostomy tube regarding duration of tube insertion.
    Description
    Number of trauma patients who will have emergent small vs large thoracostomy tube regarding duration of tube insertion.
    Time Frame
    baseline

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: all chest trauma patients with significant hemothorax, pneumothorax or combined hemo-pneumothorax Exclusion Criteria: any chest trauma patients undergoing thoracotomy or thoracic surgery for any other reason for example : diaphragmatic tear,flail chest or sternal fracture
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    amr mohamed mamdouh, resident
    Phone
    +201000566770
    Email
    amrmamdouh_95@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    hussein elkhayat, assistant professor
    Phone
    +201005549653
    Email
    Elkhayat@aun.edu.eg

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23206714
    Citation
    Cooke DT, David EA. Large-bore and small-bore chest tubes: types, function, and placement. Thorac Surg Clin. 2013 Feb;23(1):17-24, v. doi: 10.1016/j.thorsurg.2012.10.006.
    Results Reference
    background
    PubMed Identifier
    2679468
    Citation
    Meyer JA. Gotthard Bulau and closed water-seal drainage for empyema, 1875-1891. Ann Thorac Surg. 1989 Oct;48(4):597-9. doi: 10.1016/s0003-4975(10)66876-2.
    Results Reference
    background
    PubMed Identifier
    9436605
    Citation
    Van Schil PE. Thoracic drainage and the contribution of Gotthard Bulau. Ann Thorac Surg. 1997 Dec;64(6):1876. No abstract available.
    Results Reference
    background
    PubMed Identifier
    19022041
    Citation
    Monaghan SF, Swan KG. Tube thoracostomy: the struggle to the "standard of care". Ann Thorac Surg. 2008 Dec;86(6):2019-22. doi: 10.1016/j.athoracsur.2008.08.006.
    Results Reference
    background
    PubMed Identifier
    14931188
    Citation
    HOWE BE Jr. Evaluation of chest suction with an artificial thorax. Surg Forum. 1951:1-7. No abstract available.
    Results Reference
    background
    PubMed Identifier
    3542404
    Citation
    Miller KS, Sahn SA. Chest tubes. Indications, technique, management and complications. Chest. 1987 Feb;91(2):258-64. doi: 10.1378/chest.91.2.258. No abstract available.
    Results Reference
    background
    PubMed Identifier
    27499983
    Citation
    Filosso PL, Sandri A, Guerrera F, Ferraris A, Marchisio F, Bora G, Costardi L, Solidoro P, Ruffini E, Oliaro A. When size matters: changing opinion in the management of pleural space-the rise of small-bore pleural catheters. J Thorac Dis. 2016 Jul;8(7):E503-10. doi: 10.21037/jtd.2016.06.25.
    Results Reference
    background
    PubMed Identifier
    28673640
    Citation
    Tanizaki S, Maeda S, Sera M, Nagai H, Hayashi M, Azuma H, Kano KI, Watanabe H, Ishida H. Small tube thoracostomy (20-22 Fr) in emergent management of chest trauma. Injury. 2017 Sep;48(9):1884-1887. doi: 10.1016/j.injury.2017.06.021. Epub 2017 Jun 23.
    Results Reference
    background
    PubMed Identifier
    19204512
    Citation
    Rivera L, O'Reilly EB, Sise MJ, Norton VC, Sise CB, Sack DI, Swanson SM, Iman RB, Paci GM, Antevil JL. Small catheter tube thoracostomy: effective in managing chest trauma in stable patients. J Trauma. 2009 Feb;66(2):393-9. doi: 10.1097/TA.0b013e318173f81e.
    Results Reference
    background
    PubMed Identifier
    24142946
    Citation
    Towards evidence-based emergency medicine: best BETs from the Manchester Royal Infirmary. BET 4: does size matter? Chest drains in haemothorax following trauma. Emerg Med J. 2013 Nov;30(11):965-7. doi: 10.1136/emermed-2013-203139.4.
    Results Reference
    background
    PubMed Identifier
    22327984
    Citation
    Inaba K, Lustenberger T, Recinos G, Georgiou C, Velmahos GC, Brown C, Salim A, Demetriades D, Rhee P. Does size matter? A prospective analysis of 28-32 versus 36-40 French chest tube size in trauma. J Trauma Acute Care Surg. 2012 Feb;72(2):422-7. doi: 10.1097/TA.0b013e3182452444.
    Results Reference
    background
    PubMed Identifier
    23609291
    Citation
    ATLS Subcommittee; American College of Surgeons' Committee on Trauma; International ATLS working group. Advanced trauma life support (ATLS(R)): the ninth edition. J Trauma Acute Care Surg. 2013 May;74(5):1363-6. doi: 10.1097/TA.0b013e31828b82f5. No abstract available.
    Results Reference
    background

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