Menu
Recruiting NCT06937450

Traumatic Hemothorax Drainage and Daily Lavage

No phase Interventional Hemothorax; Traumatic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CLR Irrigator, Serial Lavage and Drainage, 28 Fr Open Chest Tube, Percutaneous 14Fr Chest Tube.
Who it may be relevant to
Registry conditions: Hemothorax; Traumatic. Basic parameters: from 15 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Traumatic Hemothorax Treatment With 14-Fr Pigtail Catheters or Large Bore (~28Fr) Chest Tubes With Daily Irrigation: A Pilot Single-Arm Intervention Study

Overview

This HTX treatment study evaluates the effects of chest tube size and the benefits of daily irrigations on acute HTX. 20 acutely injured but stable trauma patients requiring a chest tube for HTX will be enrolled. Patients will be assigned a 28Fr or 14 Fr chest tube with serial lavage and drainage. The endpoints will be HTX volume (by CT scan), complications, additional interventions, hospital length of stay, chest tube duration, provider feedback, and patient-reported outcomes.

Detailed description

This hemothorax (HTX) treatment study will evaluate the effects of chest tube size and daily lavage on HTX management outcomes. A total of 20 stable trauma patients requiring a chest tube for HTX will be recruited and consented. These patients will then undergo either 28Fr or 14Fr chest tube placement, depending on the preference of the treatment team at the time of placement. The study will include 10 patients with each type of chest tube (28Fr and 14Fr). Daily lavage will then be performed at 24h and 48h post-placement. Patients will be compared to historical control patients from the trauma registry who received either 28Fr or 14Fr chest tube placement followed by an initial lavage only. The primary endpoint will be the need for additional interventions such as tPA, additional chest tubes, thoracoscopic surgery (VATS), or thoracotomy. Secondary endpoints will include X-ray appearance at 72 hours, volume of HTX on CT at 72 hours, procedural complications, development of empyema (safety endpoint), development of delayed bleeding (safety endpoint), hospital length of stay, chest tube duration, provider feedback, and patient-reported outcomes.

Interventions

  • Device CLR Irrigator
    All enrolled patients will have their hemothorax treated with a CLR device that allows for easy suction and irrigation through indwelling catheters,
  • Procedure Serial Lavage and Drainage
    The current protocol is to do a singular lavage and drainage, this study will investigate the benefits of daily lavage.
  • Device 28 Fr Open Chest Tube
    Patients will have a standard 28 Fr open chest tube or a percutaneous 14Fr chest tube placed.
  • Device Percutaneous 14Fr Chest Tube
    Patients will have a standard 28 Fr open chest tube, or a percutaneous 14Fr chest tube placed.

Primary outcome measures

  • Remaining Hemothorax Volume at 72 hours [Time frame: 72 hours]
Secondary outcome measures (7)
  • Number of patients requiring intervention for retained hemothorax (excluding those who require intervention for other treatment) [Time frame: Through hospital discharge or 30 days]
  • Patient Tolerability - Numerical Rating Scale Insertion Perception Experience [Time frame: 1 hour, 24 hours, 48 hours]
  • Patient Tolerability - Insertion Perception Experience (IPE) Perception Experience (IPE) [Time frame: 1 hour]
  • Ease of CLR System Use - Industry-Standard System Usability Scale (SUS) [Time frame: 1 hour, 24 hours, 48 hours]
  • Chest Tube Placement Duration [Time frame: Through discharge or 30 days]
  • Length of hospital stay [Time frame: Through discharge or 30 days]
  • Aggregate Hospital Charges for Patient Stay [Time frame: Through discharge or 30 days]

Eligibility criteria

Inclusion criteria

  • Able to provide consent for the research study
  • More than 15 years of age
  • Presence of acute traumatic HTX or HTX-PTX diagnosed on chest CT scan within 24 hours of injury and clinical indication for drainage (hemothorax of moderate or large size greater then 300 mL)
  • Hemodynamic stability (heart rate 120 beats per minute; systolic blood pressure 90 mmHg)
  • Bilateral or unilateral hemothorax of greater than 300 mL HTX by Mergo Formula from chest CT
  • Able to complete the entire study including randomization, tube placement, lavages and final CT Scan.

Exclusion criteria

  • Less than 15 years of Age
  • Prisoner
  • Pregnant due to the risk of CT scans
  • HTX or HTX-PTX not requiring drainage or drainage performed prior to randomization/enrollment
  • Patients undergoing operative intervention (i.e. thoracotomy) as initial management of hemothorax (6) Persistent hemodynamic instability after initial resuscitation and CT imaging

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Single group
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Penn Presbyterian Medical Center — Philadelphia

Identifiers

NCT: NCT06937450 · 855480

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗