Pleural Irrigation With a Novel Devise.
ConditionPleural Effusion Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeth Israel Deaconess Medical Center
About this trial
Single-arm pilot trial of the use of intrapleural saline irrigation to treat retained pleural infections for patients with contraindications to standard of care intrapleural enzymatic therapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Retained pleural effusion identified via bedside ultrasound within the first 24 hours after chest tube insertion
Patient is contraindicated from receiving intrapleural enzymatic therapy within the first 24 hours after chest tube insertion
Disqualifiers
Non-infectious cause of pleural fluid analysis findings listed above identified (e.g. malignancy)
Post-procedural empyema or complicated parapneumonic effusion
Trial design
Design model
Single group
Treatments tested in this trial
of intrapleural saline irrigation with CLR irrigator
Devicepatients will have a CLRTM port and CLRTM irrigator (CLR Medical, Calverton, MD, USA) added to their chest tube and atrium circuit to facilitate pleural irrigation.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: TreatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Radiographic improvement (reduction in the ammount of pleural effusion messured in centimeters) by bed side ultrasound day 1,2,3,4,5.
Time frame
Daily for 8 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov