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
About this trial
This is an interventional treatment trial for Traumatic Pneumothorax and Hemothorax
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
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
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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Emergency Small vs Large Tube Thoracostomy in Chest Trauma Patients.
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