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Talc Outpatient Pleurodesis With Indwelling Catheter

NCT03973957 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2019-06-04

No results posted yet for this study

Summary

This study will be a prospective, randomized trial comparing a new protocol to the standard of care. The investigators protocol and the standard of care involves a previously established procedure that will be completed in the investigators pulmonary procedure unit. The study will include using previously, well-established procedures (indwelling pleural catheter placement, talc slurry administration through an indwelling pleural catheter, pleuroscopy with talc poudrage administration) in addition to a new protocol (at home continuous drainage via indwelling pleural catheter).

Conditions

  • Pleural Effusion
  • Pleural Diseases
  • Malignant Pleural Effusion

Interventions

DEVICE

Indwelling pleural catheter placement

Indwelling pleural catheter placement by interventional pulmonologist

DRUG

Fentanyl Citrate

Administration of intravenous fentanyl prior to talc slurry instillation in order to avoid pain associated with talc slurry application

DRUG

Talc Slurry

Administration of 5 grams of medical grade sterile talc mixed in 50 milliliters of normal saline solution via indwelling pleural catheter for purposes of talc slurry pleurodesis

DEVICE

Drainage collection bag

Attachment of one-way Heimlich valve with drainage collection bag circuit to indwelling pleural catheter after talc slurry application for purposes of drainage and pleurodesis in the outpatient setting rather than the inpatient setting.

Sponsors & Collaborators

  • The Cooper Health System

    lead OTHER

Principal Investigators

  • Wissam Abouzgheib · Cooper health system

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-05-27
Primary Completion
2021-01-31
Completion
2021-01-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03973957 on ClinicalTrials.gov