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

NCT03167723 | Completed Results DMC FDA Device

• 2 other identifiers: IRB00081328Pro00020984
• Study Type: interventional
• Target: 193
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemothorax; Hemopneumothorax; Traumatic; Empyema; Chest Tube Size

Keywords

Chest tube size; Hemothorax; Empyema

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Duration of Chest Tube Placement.

  90 days

• Number of Participants Stratified by Length of Hospitalization Stay

  90 days

• Change in Subjective Pain Scores From Baseline at 90 Days

  90 days

• Hemodynamic Stability Post-insertion

  90 days

• Initial Drainage From Chest Tube at 5 Minutes

  5 Minutes

Study Arms (2)

28 French chest tube for hemothorax

EXPERIMENTAL

28 French straight chest tube placed for non-emergent drainage of hemothorax or hemopneumothorax

Device: Chest tube placement

14 French chest tube for hemothorax

EXPERIMENTAL

14 French thal chest tube placed for non-emergent drainage of hemothorax or hemopneumothorax

Device: Chest tube placement

Interventions

Chest tube placement DEVICE

Placing tube thoracostomy for hemothorax or hemopneumothorax utilizing maximal barrier precautions.

14 French chest tube for hemothorax; 28 French chest tube for hemothorax

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

Related Publications (4)

• 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.

  PMID: 18716687 BACKGROUND

• 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: 10.1097/TA.0b013e3182452444.

  PMID: 22327984 RESULT

• 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 Jan;101(2):17-22. doi: 10.1002/bjs.9377.

  PMID: 24375295 RESULT

• McCartt J, Ross SW, Cunningham KW, Wang H, Sealey L, Brake J, Christmas A, Sachdev G, Green J, Thomas BW. A Randomized Non-Inferiority Clinical Trial of 14Fr Thal versus 28Fr Tube Thoracostomy for Traumatic Hemothorax. Am Surg. 2025 Apr;91(4):579-586. doi: 10.1177/00031348241308907. Epub 2024 Dec 19.

  PMID: 39700058 DERIVED

MeSH Terms

Conditions

Hemothorax; Hemopneumothorax; Empyema

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Suppuration; Infections; Inflammation

Results Point of Contact

• Title: Bradley Thomas MD
• Organization: Atrium Health Wake Forest

bradley.thomas@atriumhealth.org

704-355-3176

Study Officials

• Bradley W Thomas, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Investigator masked to outcomes data.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2017
• First Posted: May 30, 2017
• Study Start: May 8, 2017
• Primary Completion: December 20, 2021
• Study Completion: December 20, 2021
• Last Updated: March 29, 2023
• Results First Posted: March 29, 2023

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)