Emergency Small vs Large Tube Thoracostomy in Chest Trauma Patients.

Study Overview
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Brief Summary
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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
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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.

Official Title
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Emergency Small vs Large Tube Thoracostomy in Chest Trauma Patients.

Conditions
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Traumatic Pneumothorax and Hemothorax

Intervention / Treatment
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* Procedure: tube thoracostomy


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Small sized chest tube<br>Insertion of small sized chest tube in patients with traumatic hemothorax, pneumothorax or hemopneumothorax. | Procedure: tube thoracostomy<br>* insertion of intercostal tube for drainage of traumatic hemothorax or pneumothorax<br>|
| Active Comparator: Large sized chest tube<br>insertion of large sized chest tube in patients with traumatic hemothorax, pneumothorax or hemopneumothorax. | Procedure: tube thoracostomy<br>* insertion of intercostal tube for drainage of traumatic hemothorax or pneumothorax<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | baseline | 
| 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. | baseline |