Pleural Suction Additional to Thoracostomy Tube for Traumatic Hemothorax
Primary Purpose
Traumatic Hemothorax
Status
Suspended
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
Pleural aspiration
Sponsored by
About this trial
This is an interventional treatment trial for Traumatic Hemothorax
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
Sites / Locations
- Pablo Tobon Uribe Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Pleural aspiration
Closed Thoracostomy
Arm Description
Pleural aspiration under sedation
Actual management
Outcomes
Primary Outcome Measures
Clotted hemothorax
Rate of clotted hemothorax found after Thoracostomy tube procedure or pleural aspiration procedure
Empyema
Rate of empyema found after Thoracostomy tube procedure
Secondary Outcome Measures
Pleural aspiration procedure complications
Describe the percentage of patients with complications associated with the pleural aspiration procedure in patients scheduled for thoracostomy tube procedure
Full Information
NCT ID
NCT04525365
First Posted
June 11, 2020
Last Updated
September 20, 2023
Sponsor
Hospital Pablo Tobón Uribe
1. Study Identification
Unique Protocol Identification Number
NCT04525365
Brief Title
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Suspended
Why Stopped
It was not possible to achieve adequate recruitment to complete the necessary sample. The rate at which patients are recruited does not allow for continued participation
Study Start Date
March 17, 2020 (Actual)
Primary Completion Date
March 5, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Pablo Tobón Uribe
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Hemothorax
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Pleural suction under sedation vs Tube Thoracostomy without pleural suction
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pleural aspiration
Arm Type
Experimental
Arm Description
Pleural aspiration under sedation
Arm Title
Closed Thoracostomy
Arm Type
Active Comparator
Arm Description
Actual management
Intervention Type
Procedure
Intervention Name(s)
Pleural aspiration
Other Intervention Name(s)
Closed Thoracostomy
Intervention Description
Pleural aspiration
Primary Outcome Measure Information:
Title
Clotted hemothorax
Description
Rate of clotted hemothorax found after Thoracostomy tube procedure or pleural aspiration procedure
Time Frame
One month
Title
Empyema
Description
Rate of empyema found after Thoracostomy tube procedure
Time Frame
One month
Secondary Outcome Measure Information:
Title
Pleural aspiration procedure complications
Description
Describe the percentage of patients with complications associated with the pleural aspiration procedure in patients scheduled for thoracostomy tube procedure
Time Frame
One month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Willfredy Castano, MD
Organizational Affiliation
Pablo Tobon Uribe Hospital, Thoracic Surgeon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pablo Tobon Uribe Hospital
City
Medellin
State/Province
Antioquia
ZIP/Postal Code
050034
Country
Colombia
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
We not consider to share the participant data by laws in our country
Citations:
PubMed Identifier
22856496
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.
Results Reference
background
PubMed Identifier
18716687
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.
Results Reference
background
PubMed Identifier
23433600
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.
Results Reference
background
PubMed Identifier
22310111
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.
Results Reference
background
PubMed Identifier
26815469
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.
Results Reference
background
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Pleural Suction Additional to Thoracostomy Tube for Traumatic Hemothorax
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