Clinical trial NCT04525365: Pleural Suction Additional to Thoracostomy Tube for Traumatic Hemothorax
Official title: Pleural Suction and Evacuation in the Moment of Thoracostomy Tube Procedure in Traumatic Hemothorax Patients: A Randomized Study
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Traumatic Hemothorax
Lead sponsor: Hospital Pablo Tobón Uribe
Sponsor class: OTHER
First posted: 2020-08-25
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pleural suction under sedation vs Tube Thoracostomy without pleural suction
Primary purpose: TREATMENT

Brief summary: 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Clotted hemothorax
timeFrame: One month
measure: Empyema
timeFrame: One month
Secondary outcomes:
measure: Pleural aspiration procedure complications
timeFrame: One month
Other outcomes:
Locations:
city: Medellin
country: Colombia
facility: Pablo Tobon Uribe Hospital
state: Antioquia
Study officials:
affiliation: Pablo Tobon Uribe Hospital, Thoracic Surgeon
name: Willfredy Castano, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ramanathan R, Wolfe LG, Duane TM. Initial suction evacuation of traumatic hemothoraces: a novel approach to decreasing chest tube duration and complications. Am Surg. 2012 Aug;78(8):883-7.
citation: Karmy-Jones R, Holevar M, Sullivan RJ, Fleisig A, Jurkovich GJ. Residual hemothorax after chest tube placement correlates with increased risk of empyema following traumatic injury. Can Respir J. 2008 Jul-Aug;15(5):255-8. doi: 10.1155/2008/918951.
citation: Bradley M, Okoye O, DuBose J, Inaba K, Demetriades D, Scalea T, O'Connor J, Menaker J, Morales C, Shiflett T, Brown C. Risk factors for post-traumatic pneumonia in patients with retained haemothorax: results of a prospective, observational AAST study. Injury. 2013 Sep;44(9):1159-64. doi: 10.1016/j.injury.2013.01.032. Epub 2013 Feb 19.
citation: DuBose J, Inaba K, Demetriades D, Scalea TM, O'Connor J, Menaker J, Morales C, Konstantinidis A, Shiflett A, Copwood B; AAST Retained Hemothorax Study Group. Management of post-traumatic retained hemothorax: a prospective, observational, multicenter AAST study. J Trauma Acute Care Surg. 2012 Jan;72(1):11-22; discussion 22-4; quiz 316. doi: 10.1097/TA.0b013e318242e368.
citation: Villegas MI, Hennessey RA, Morales CH, Londono E. Risk factors associated with the development of post-traumatic retained hemothorax. Eur J Trauma Emerg Surg. 2011 Dec;37(6):583-9. doi: 10.1007/s00068-010-0064-3. Epub 2010 Dec 4.