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

Not Applicable

Completed

• Conditions: Empyema; Hemothorax; Hemopneumothorax; Traumatic; Chest Tube Size
• Interventions: Device: Chest tube placement

• Registration Number: NCT03167723
• Lead Sponsor: Wake Forest University Health Sciences

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-08
• Study First Submitted: 2017-05-24
• Study First Submitted QC: 2017-05-25
• Study First Posted: 2017-05-30
• Primary Completion: 2021-12-20
• Study Completion: 2021-12-20
• Status Verified: 2022-08
• Results First Submitted: 2022-11-30
• Results First Submitted QC: 2023-03-06
• Last Update Submitted: 2023-03-06
• Results First Posted: 2023-03-29
• Last Update Posted: 2023-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 193

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.

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
28 French chest tube for hemothorax	Chest tube placement	28 French straight chest tube placed for non-emergent drainage of hemothorax or hemopneumothorax
14 French chest tube for hemothorax	Chest tube placement	14 French thal chest tube placed for non-emergent drainage of hemothorax or hemopneumothorax

Primary Outcome Measures

Name	Time	Method
Number of Participants With Retained Hemothorax Following Initial Chest Tube Placement Requiring Intervention	90 days	Number of Participants with Retained hemothorax requiring an additional intervention, either video-assisted thoracoscopic surgery (VATS) or additional thoracostomy tube placement.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Stratified by Length of Hospitalization Stay	90 days	Number of weeks spent in hospital
Change in Subjective Pain Scores From Baseline at 90 Days	90 days	Assessed with 0-10 numeric pain rating scale - the higher the number, the more severe the pain
Duration of Chest Tube Placement.	90 days	Number of days with chest tube placement
Hemodynamic Stability Post-insertion	90 days	determined by vital signs: temperature, heart rate, blood pressure, oxygen saturation (Systolic Blood Pressure \<90mm Hg)
Initial Drainage From Chest Tube at 5 Minutes	5 Minutes	Milliliters of chest tube drainage at 5 minutes
Time to Radiographic Resolution of Pneumothorax/Hemothorax/Hemopneumothorax	90 days	Number of days until radiographic resolution of pneumothorax/hemothorax/hemopneumothorax
Recurrent Pneumothorax/Hemothorax/Hemopneumothorax After Tube Removal	90 days	Number of Participants with Recurrent pneumothorax/hemothorax/hemopneumothorax after tube removal
Tube Specific Complications: Air Leak, Tube Malposition, & Tube Migration	90 days	Number of Tube specific complications: Air leak, tube malposition, \& tube migration
Readmission for Chest Tube Related Complications	90 days	Number of Participants readmitted for chest tube related complications

Trial Locations

Locations (1)

Carolinas Medical Center; 🇺🇸 Charlotte, North Carolina, United States