Pleural Suction Additional to Thoracostomy Tube for Traumatic Hemothorax

September 20, 2023 updated by: Hospital Pablo Tobón Uribe

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

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

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Colombia
    • Antioquia
      • Medellin, Antioquia, Colombia, 050034
        • Pablo Tobon Uribe Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pleural aspiration
Pleural aspiration under sedation
Procedure: Pleural aspiration
Pleural aspiration
Other Names:
  • Closed Thoracostomy
Active Comparator: Closed Thoracostomy
Actual management
Procedure: Pleural aspiration
Pleural aspiration
Other Names:
  • Closed Thoracostomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clotted hemothorax
Time Frame: One month
Rate of clotted hemothorax found after Thoracostomy tube procedure or pleural aspiration procedure
One month
Empyema
Time Frame: One month
Rate of empyema found after Thoracostomy tube procedure
One month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pleural aspiration procedure complications
Time Frame: One month
Describe the percentage of patients with complications associated with the pleural aspiration procedure in patients scheduled for thoracostomy tube procedure
One month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Pablo Tobón Uribe

Investigators

  • Principal Investigator: Willfredy Castano, MD, Pablo Tobon Uribe Hospital, Thoracic Surgeon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 17, 2020

Primary Completion (Estimated)

March 5, 2024

Study Completion (Estimated)

July 31, 2024

Study Registration Dates

First Submitted

June 11, 2020

First Submitted That Met QC Criteria

August 20, 2020

First Posted (Actual)

August 25, 2020

Study Record Updates

Last Update Posted (Actual)

September 22, 2023

Last Update Submitted That Met QC Criteria

September 20, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017.019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We not consider to share the participant data by laws in our country

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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