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Traumatic Hemothorax Drainage and Daily Lavage

ConditionHemothorax; Traumatic
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15+
SponsorUniversity of Pennsylvania

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • CLR Irrigator

    Device

    All enrolled patients will have their hemothorax treated with a CLR device that allows for easy suction and irrigation through indwelling catheters,

  • Serial Lavage and Drainage

    Procedure/Surgery

    The current protocol is to do a singular lavage and drainage, this study will investigate the benefits of daily lavage.

  • 28 Fr Open Chest Tube

    Device

    Patients will have a standard 28 Fr open chest tube or a percutaneous 14Fr chest tube placed.

  • Percutaneous 14Fr Chest Tube

    Device

    Patients will have a standard 28 Fr open chest tube, or a percutaneous 14Fr chest tube placed.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Open 28 Fr Tube Thoracostomy with Daily Lavage and DrainageExperimental treatment 3 interventions
Group B: Percutaneous 14-Fr Catheter with Daily Lavage and DrainageExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Remaining Hemothorax Volume at 72 hours

Assessed by CT and Mergo Formula

Time frame
72 hours

Secondary outcomes

1

Number of patients requiring intervention for retained hemothorax (excluding those who require intervention for other treatment)

All interventions focused on resolving any remaining hemothorax

Time frame
Through hospital discharge or 30 days
2

Patient Tolerability - Numerical Rating Scale Insertion Perception Experience

Patient perception of the drainage and lavage procedure ranging from 1 (tolerable) to 5 (worst experience of my life). Did this Drainage and Lavage procedure resolve, lessen or worsen the patient's symptoms?

Time frame
1 hour, 24 hours, 48 hours
3

Patient Tolerability - Insertion Perception Experience (IPE) Perception Experience (IPE)

Patient perception of the chest tube insertion procedure. 1. = It was okay, I can tolerate it, I can do it again. 2. = It was okay, but I don't want to go through this again. 3. = It was a bad experience for me. 4. = It was a worse experience for me. 5. = It was the worst experience of my life!

Time frame
1 hour
4

Ease of CLR System Use - Industry-Standard System Usability Scale (SUS)

By physician who used the CLR Irrigator System. 5-point Likert scale from strongly disagree (low) to strongly agree (high).

Time frame
1 hour, 24 hours, 48 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Pennsylvania

Lead sponsor

CLR Medical

Collaborator

Source ClinicalTrials.gov
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