N/A
N=109
Prospective Evaluation of 14F Thal Tube vs 28 French Chest Tube for Hemothorax and Use of Maximum Barrier Precautions
Hemothorax · Hemopneumothorax; Traumatic · Empyema · Chest Tube Size
Bottom Line
View on ClinicalTrials.gov: NCT03167723 ↗Enrolled (actual)
109
Serious AEs
0.0%
Results posted
Mar 2023
Primary outcome: Primary: Number of Participants With Retained Hemothorax Following Initial Chest Tube Placement Requiring Intervention — 51; 48 Number of Participants — p=0.036
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Chest tube placement (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Retained Hemothorax Following Initial Chest Tube Placement Requiring Intervention |
51; 48 | 0.036 sig |
| SECONDARY Duration of Chest Tube Placement. |
3.9; 3.9 | — |
| SECONDARY Number of Participants Stratified by Length of Hospitalization Stay |
20; 15; 19; 15; 7; 6 | — |
| SECONDARY Change in Subjective Pain Scores From Baseline at 90 Days |
0; 0 | — |
| SECONDARY Hemodynamic Stability Post-insertion |
2; 1 | — |
| SECONDARY Initial Drainage From Chest Tube at 5 Minutes |
150; 100 | — |
| SECONDARY Tube Specific Complications: Air Leak, Tube Malposition, & Tube Migration |
7; 5 | — |
| SECONDARY Time to Radiographic Resolution of Pneumothorax/Hemothorax/Hemopneumothorax |
0.5; 1 | — |
| SECONDARY Recurrent Pneumothorax/Hemothorax/Hemopneumothorax After Tube Removal |
5; 1 | — |
| SECONDARY Readmission for Chest Tube Related Complications |
9; 4 | — |
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.
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT03167723). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.