Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pleural Effusion Pleural Diseases Malignant Pleural Effusion | Device: Indwelling pleural catheter placement Drug: Fentanyl Citrate Drug: Talc Slurry Device: Drainage collection bag | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 124 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Prospective, Randomized and controlled trial |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Talc Outpatient Pleurodesis With Indwelling Catheter: A Randomized Controlled Trial |
Actual Study Start Date : | May 27, 2019 |
Estimated Primary Completion Date : | January 31, 2021 |
Estimated Study Completion Date : | January 31, 2021 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Control Arm
If undergoing talc slurry in the control arm, the patient will undergo IPC placement in the pulmonary procedure unit on day one of admission. The IPC will then be connected to a pleur-evac as standard of care protocol for chest tube drainage. At 1-2 hours post-IPC placement a chest x-ray will be obtained to assess for full lung re-expansion. If the lung does not fully expand the patient will be excluded from the study. Once full lung re-expansion has occurred, talc slurry will be ordered and the patient will be given 25 mcg of IV fentanyl. Talc slurry (5 g sterile talc, brand name Steritalc, mixed with 50 cc or sterile normal saline in a syringe, per Cooper University Pharmacy protocol) will be administered via the IPC. The patient will remain in the hospital, with continuous drainage measured daily for 2-5 days, depending on drainage of the effusion.
|
Device: Indwelling pleural catheter placement
Indwelling pleural catheter placement by interventional pulmonologist
Other Names:
Drug: Fentanyl Citrate Administration of intravenous fentanyl prior to talc slurry instillation in order to avoid pain associated with talc slurry application
Other Name: "Pain medication"
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
|
Active Comparator: Intervention Arm
An indwelling pleural catheter (IPC) will be placed during this visit. After complete drainage of the effusion, a chest x-ray will be done to determine if full lung reexpansion occurs. If there is lack of full lung re-expansion the patient will be excluded from the study at this time. If full lung re-expansion is present, the patient will receive an intravenous line (IV) by our nursing staff for analgesia prior to talc administration and will be pre-treated with 25 mcg of IV fentanyl. Talc slurry (5 g sterile talc, brand name Steritalc, mixed with 50 cc or sterile normal saline in a syringe, per Cooper University Pharmacy protocol) will then be administered through the IPC. The IPC will then be connected to a circuit that will consist of the IPC connected to a 4-liter fluid drainage collection bag via a one-way Heimlich valve (picture of set up included in additional documents). |
Device: Indwelling pleural catheter placement
Indwelling pleural catheter placement by interventional pulmonologist
Other Names:
Drug: Fentanyl Citrate Administration of intravenous fentanyl prior to talc slurry instillation in order to avoid pain associated with talc slurry application
Other Name: "Pain medication"
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.
Other Name: "Leg bag"
|
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Wissam Abouzgheib, MD | 856-342-2406 | abouzgheib-wissam@cooperhealth.edu |
United States, New Jersey | |
Cooper University Hospital | Recruiting |
Camden, New Jersey, United States, 08103 | |
Contact: Wissam Abouzgheib 856-342-2406 |
Principal Investigator: | Wissam Abouzgheib | Cooper health system |
Tracking Information | |||||
---|---|---|---|---|---|
First Submitted Date ICMJE | May 27, 2019 | ||||
First Posted Date ICMJE | June 4, 2019 | ||||
Last Update Posted Date | June 4, 2019 | ||||
Actual Study Start Date ICMJE | May 27, 2019 | ||||
Estimated Primary Completion Date | January 31, 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Time to pleurodesis [ Time Frame: Up to one month from placement of indwelling pleural catheter ] Will measure the time to pleurodesis in the individual arms
|
||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Talc Outpatient Pleurodesis With Indwelling Catheter | ||||
Official Title ICMJE | Talc Outpatient Pleurodesis With Indwelling Catheter: A Randomized Controlled Trial | ||||
Brief 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). | ||||
Detailed Description | The study design is a prospective, randomized and controlled trial comparing a new protocol to the standard of care. To the investigators knowledge, there is no similar protocol and this will be a single center, pilot study. The control arm will consist of subjects who meet the inclusion criteria for the study and will receive current standard of care management for paramalignant pleural effusion. This will consist of either an indwelling pleural catheter (IPC) placement with subsequent talc slurry administration and hospital admission for continuous drainage, or schedule medical pleuroscopy with talc insufflation poudrage and subsequent IPC placement for continuous drainage while in the hospital. The intervention arm will consist of subjects who meet the inclusion criteria and then will be scheduled for IPC placement in the pulmonary procedure unit as either an outpatient visit or during their hospital admission (if the subject is already admitted to the hospital and recruited via our inpatient consult service). The subjects in this arm will then go home or back to their original admission status with a drainage bag for continuous drainage on the same day as the procedure. This protocol will utilize a circuit with an IPC connected to a continuous drainage bag via a one-way Heimlich valve. It is important to note that while utilizing this circuit is a new protocol for patients with paramalignant pleural effusions, the protocol is the current standard of care practice for patients with pneumothorax and persistent air leak, and is being utilized regularly for these patients by the investigator's department as standard of care for patient needing long-term chest tubes while at home. | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Prospective, Randomized and controlled trial Masking: None (Open Label)Primary Purpose: Treatment |
||||
Condition ICMJE |
|
||||
Intervention ICMJE |
|
||||
Study Arms ICMJE |
|
||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status ICMJE | Unknown status | ||||
Estimated Enrollment ICMJE |
124 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | January 31, 2021 | ||||
Estimated Primary Completion Date | January 31, 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||
Sex/Gender ICMJE |
|
||||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03973957 | ||||
Other Study ID Numbers ICMJE | 19-020 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
|
||||
IPD Sharing Statement ICMJE |
|
||||
Responsible Party | Wissam Abouzgheib, The Cooper Health System | ||||
Study Sponsor ICMJE | The Cooper Health System | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
|
||||
PRS Account | The Cooper Health System | ||||
Verification Date | June 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |