Pleural Suction Additional to Thoracostomy Tube for Traumatic Hemothorax

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-17

Study Completion Date

2024-07-31

Brief Summary

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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

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Detailed Description

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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.

Sample size is of 250 participants, and is planned for 20 months.

Conditions

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Traumatic Hemothorax

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Pleural suction under sedation vs Tube Thoracostomy without pleural suction

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pleural aspiration

Pleural aspiration under sedation

Group Type EXPERIMENTAL

Pleural aspiration

Intervention Type PROCEDURE

Pleural aspiration

Closed Thoracostomy

Actual management

Group Type ACTIVE_COMPARATOR

Pleural aspiration

Intervention Type PROCEDURE

Pleural aspiration

Interventions

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Pleural aspiration

Intervention Type PROCEDURE

Other Intervention Names

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Closed Thoracostomy

Eligibility Criteria

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Inclusion Criteria

* Traumatic hemothorax that needs a Thoracostomy tube procedure

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No