Prospective Evaluation of 14F Thal Tube vs 28 French Chest Tube for Hemothorax and Use of Maximum Barrier Precautions

Empyema Clinical Trial

Official title:

Prospective Evaluation of 14F Thal Tube vs 28 French Chest Tube for Hemothorax and Use of Maximum Barrier Precautions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03167723
• Other study ID #: IRB00081328
• Secondary ID: Pro00020984
• Status: Completed
• Phase: N/A
• Start date: May 8, 2017
• Est. completion date: December 20, 2021

Study information

• Verified date: August 2022
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Traumatic hemothorax and hemopneumothorax are common diagnoses which are typically treated by placement of a chest tube. 28-32 Fr chest tubes have previously been shown equivalent to 36-40 Fr chest tubes for the non-emergent drainage of hemothorax. A smaller study has found 14 Fr pigtails had less pain than larger tubes but was not powered to compare outcomes. We seek to perform a prospective randomized trial that is adequately powered comparing efficacy of 14 Fr thal tubes to 28 Fr chest tubes for non-emergent drainage of hemothorax and hemopneumothorax. Additionally, we will employ maximal barrier precautions for all chest tube insertions and compare empyema rates to our historical controls.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 193
• Est. completion date: December 20, 2021
• Est. primary completion date: December 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• The patient is admitted to the trauma service.
• The patient has a hemothorax and/or or hemopneumothorax, requiring thoracostomy tube placement.
• Thoracostomy tube placement is able to be performed or witnessed by an investigator listed on the study.
• The patient has not had a chest tube in the past year.
• The patient is >18 years of age.
• In the event the patient is decisionally impaired, consent will be obtained from the individual's legally authorized representative (LAR) or from the individual's healthcare power of attorney (HPA).
• In the instance of reversible impairment, initial consent would be obtained from the LAR/HPA and the patient will be approached for consent once he/she is deemed mentally competent by the care provider.

Exclusion Criteria:

• The patient is incarcerated
• The patient is known to be pregnant
• The patient is < 18 years of age
• The patient is hemodynamically unstable, requiring emergent chest tube placement (in <10 minutes from evaluation).

Related Conditions & MeSH terms

• Chest Tube Size
• Empyema
• Hemopneumothorax
• Hemopneumothorax; Traumatic
• Hemothorax

Intervention

Device:
• Chest tube placement
Placing tube thoracostomy for hemothorax or hemopneumothorax utilizing maximal barrier precautions.

Locations

Country	Name	City	State
United States	Carolinas Medical Center	Charlotte	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

References & Publications (3)

Inaba K, Lustenberger T, Recinos G, Georgiou C, Velmahos GC, Brown C, Salim A, Demetriades D, Rhee P. Does size matter? A prospective analysis of 28-32 versus 36-40 French chest tube size in trauma. J Trauma Acute Care Surg. 2012 Feb;72(2):422-7. doi: 10. — View 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. — View Citation

Kulvatunyou N, Erickson L, Vijayasekaran A, Gries L, Joseph B, Friese RF, O'Keeffe T, Tang AL, Wynne JL, Rhee P. Randomized clinical trial of pigtail catheter versus chest tube in injured patients with uncomplicated traumatic pneumothorax. Br J Surg. 2014 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Retained Hemothorax Following Initial Chest Tube Placement Requiring Intervention	Number of Participants with Retained hemothorax requiring an additional intervention, either video-assisted thoracoscopic surgery (VATS) or additional thoracostomy tube placement.	90 days
Secondary	Duration of Chest Tube Placement.	Number of days with chest tube placement	90 days
Secondary	Number of Participants Stratified by Length of Hospitalization Stay	Number of weeks spent in hospital	90 days
Secondary	Change in Subjective Pain Scores From Baseline at 90 Days	Assessed with 0-10 numeric pain rating scale - the higher the number, the more severe the pain	90 days
Secondary	Hemodynamic Stability Post-insertion	determined by vital signs: temperature, heart rate, blood pressure, oxygen saturation (Systolic Blood Pressure <90mm Hg)	90 days
Secondary	Initial Drainage From Chest Tube at 5 Minutes	Milliliters of chest tube drainage at 5 minutes	5 Minutes
Secondary	Tube Specific Complications: Air Leak, Tube Malposition, & Tube Migration	Number of Tube specific complications: Air leak, tube malposition, & tube migration	90 days
Secondary	Time to Radiographic Resolution of Pneumothorax/Hemothorax/Hemopneumothorax	Number of days until radiographic resolution of pneumothorax/hemothorax/hemopneumothorax	90 days
Secondary	Recurrent Pneumothorax/Hemothorax/Hemopneumothorax After Tube Removal	Number of Participants with Recurrent pneumothorax/hemothorax/hemopneumothorax after tube removal	90 days
Secondary	Readmission for Chest Tube Related Complications	Number of Participants readmitted for chest tube related complications	90 days