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临床试验/NCT04525365
NCT04525365暂停不适用

Pleural Suction and Evacuation in the Moment of Thoracostomy Tube Procedure in Traumatic Hemothorax Patients: A Randomized Study

Hospital Pablo Tobón Uribe2 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2020年3月17日最近更新:
适应症

试验速览

阶段
不适用
状态
暂停
发起方
入组人数
250
试验地点
2
主要终点
Clotted hemothorax

研究概览

简要总结

The primary treatment for traumatic hemothorax, is a thoracostomy tube. Some of these patients develop a clotted hemothorax by insufficient drainage. This complication needs surgical resolution and can generate an empyema. One strategy to reduce this complication is pleural suction under sedation before the thoracostomy tube. The aim of the study is define if the procedure really lower the incidence of clotted hemothorax. The investigators design and open label, randomized, interventional study, comparing the realization of the pleural suction and thoracostomy tube alone

详细描述

Traumatic hemothorax is a common emergency and is commonly the result of trauma, both blunt and penetrating. Although closed drainage thoracostomy is commonly adequate for the initial management of a hemothorax in most cases, failure of the closed thoracostomy and formation of clotted hemothorax can occur in up to 5 to 30% of cases. This complication requires surgical treatment and can generate an empyema, which is a serious infection.

Therefore, the investigators want to impact through a simple and low-cost procedure such as traumatic hemothorax aspiration in the adult population, prior to insertion and fixation of the thoracostomy tube under sedation, to evacuate all the hemothorax present, thus reducing the formation of clots in these patients, and the probability of clotted hemothorax.

Methods: Initially, all patients with penetrating or closed chest trauma that came to the emergency department, are evaluated clinically and with a chest x-ray. With this information, the investigators diagnose patients with traumatic hemothorax or hemopneumothorax, and if is a candidate for drainage with closed thoracostomy. The patient will receive a dose of prophylactic antibiotic, which will be 2 gr of first-generation Cephalosporin, or 600mg iv of Clindamycin for patients allergic to penicillin. At the time of performing the closed thoracostomy procedure, and after approval and signing of the informed consent for the study by the patient or his family member in charge, a consecutive number is assigned with prior randomization of each of the groups in EPIDAT 4.0. In case of being an intervention group, a superficial sedation of the patient will be carried out in the emergency department. Moderate sedation or conscious sedation is performed. The pleura is opened and a sterile adult Yankauer plastic suction cannula (Plus-vital, CE0197, Greetmed RPC) is inserted with closed suction. The cannula will be directed towards the posterior costodiaphragmatic recess at which point hemothorax aspiration will begin at -80 cubic centimeters of water (ccH2O) until complete evacuation is achieved. At the end of the suction, the hemithorax cannula is removed and a silicone 32 French (Fr) thoracostomy tube is inserted, which is subsequently fixed with a non-absorbable 0-gauge suture. The chest tube is connected to a 3-bottle thoracic drainage system ( Oasis Dry suction Water seal 3600 single collection) without continuous pleural suction. After the procedure, a control chest X-ray will be performed within 3 hours to verify the position of the tube, hemothorax drainage, and lung expansion. The clinical and radiological follow up, will be made by surgeon criteria, until the patient develop a clotted hemothorax or is discharged. The investigators will follow this patients by phone after a month. Description and treatment of any adverse events will be made.

Analysis of each of the variables will be carried out in the two groups. Chi2 test to establish statistical significance of these differences, with a bivariate analysis.

Registry of data will be made by the investigators, the source will be the clinical records, and the month phone call, will be made by secondary investigators.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Traumatic hemothorax that needs a Thoracostomy tube procedure

排除标准

  • Previous hemothorax in the same hemithorax
  • Hemodynamic instability
  • Massive hemothorax
  • Obtaining saliva, bile, intestinal or gastric material, chyle at the time of performing the procedure
  • Closed thoracostomy performed in other institution
  • Need of mayor surgical intervention in thorax
  • Contraindication for sedation

结局指标

主要结局

Clotted hemothorax

时间窗: One month

Rate of clotted hemothorax found after Thoracostomy tube procedure or pleural aspiration procedure

Empyema

时间窗: One month

Rate of empyema found after Thoracostomy tube procedure

次要结局

  • Pleural aspiration procedure complications(One month)

研究者

发起方
Hospital Pablo Tobón Uribe
申办方类型
Other
责任方
Sponsor

研究点 (2)

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