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Completed

NCT Number: NCT03167723

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

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.

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Key information

Conditions

Hemothorax Chest Tube Size Empyema Hemopneumothorax Hemopneumothorax; Traumatic Hemorrhage Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Pleural Diseases Respiratory Tract Diseases Suppuration

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Chest tube placement

Device

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

Primary outcomes

  1. Number of Participants With Retained Hemothorax Following Initial Chest Tube Placement Requiring Intervention

    Time frame: 90 days

    Number of Participants with Retained hemothorax requiring an additional intervention, either video-assisted thoracoscopic surgery (VATS) or additional thoracostomy tube placement.

Secondary outcomes

  1. Duration of Chest Tube Placement.

    Time frame: 90 days

    Number of days with chest tube placement

  2. Number of Participants Stratified by Length of Hospitalization Stay

    Time frame: 90 days

    Number of weeks spent in hospital

  3. Change in Subjective Pain Scores From Baseline at 90 Days

    Time frame: 90 days

    Assessed with 0-10 numeric pain rating scale - the higher the number, the more severe the pain

  4. Hemodynamic Stability Post-insertion

    Time frame: 90 days

    determined by vital signs: temperature, heart rate, blood pressure, oxygen saturation (Systolic Blood Pressure <90mm Hg)

  5. Initial Drainage From Chest Tube at 5 Minutes

    Time frame: 5 Minutes

    Milliliters of chest tube drainage at 5 minutes

  6. Tube Specific Complications: Air Leak, Tube Malposition, & Tube Migration

    Time frame: 90 days

    Number of Tube specific complications: Air leak, tube malposition, & tube migration

  7. Time to Radiographic Resolution of Pneumothorax/Hemothorax/Hemopneumothorax

    Time frame: 90 days

    Number of days until radiographic resolution of pneumothorax/hemothorax/hemopneumothorax

  8. Recurrent Pneumothorax/Hemothorax/Hemopneumothorax After Tube Removal

    Time frame: 90 days

    Number of Participants with Recurrent pneumothorax/hemothorax/hemopneumothorax after tube removal

  9. Readmission for Chest Tube Related Complications

    Time frame: 90 days

    Number of Participants readmitted for chest tube related complications

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
May 30, 2017
Registry last updated
Mar 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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