Quantitative Characterization of Safe Irrigation for Ventricular Shunt Catheters
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|ClinicalTrials.gov Identifier: NCT02651337|
Recruitment Status : Completed
First Posted : January 11, 2016
Results First Posted : September 21, 2020
Last Update Posted : September 21, 2020
|Condition or disease||Intervention/treatment||Phase|
|Hydrocephaly||Device: Cerebrospinal Fluid (CSF) Drainage||Not Applicable|
Primary Objective: To collect pressure and flow rate measurements during shunt revision surgeries in human patients.
Pressure recordings of the injected fluid will be obtained using disposable off-the-shelf sterile pressure transducers (which are typically used for intracranial and arterial pressures monitoring) readily available in the operating room. First, the surgeon will attempt to flush the catheter using the Alcyone in-line Flusher device. If this fails, the surgeon may elect to attempt to flush using a standard syringe attached to the catheter. The flow rates will be measured by video, recording the syringe during the flushing maneuver, and then extracting plunger motion information by applying image processing on the acquired videos. In the event the recording equipment is not available (in that these operations are usually unscheduled and sometimes urgent), the same irrigation techniques may be used without the pressure recordings.
Secondary Objective: To analyze the collected data and establish maximal allowable injection pressure and flow rate. The collected data segments for each patient will be analyzed and maximal values for pressure and the saline injection rate will be recorded in a spreadsheet. Inter-patient variation in the results, presumably due to different degrees of occlusion, will be statistically evaluated. We will also determine if any of the catheters which appear occluded in the operating room resume flow with the flushing maneuvers.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Quantitative Characterization of Safe Irrigation for Ventricular Shunt Catheters|
|Actual Study Start Date :||April 1, 2016|
|Actual Primary Completion Date :||June 4, 2016|
|Actual Study Completion Date :||June 14, 2016|
Experimental: Drainage with Alivio in-line Flusher
Volume of saline needed to drain CSF using the Alivio in-line Flusher historically compared with volume of saline needed to drain CSF using a standard syringe
Device: Cerebrospinal Fluid (CSF) Drainage
Placement of Alivio in line flusher during CSF drainage
Other Name: Alivio in line flusher
- To Demonstrate That the Flusher Can be Primed, Connected, and Activated in a Sterile Clinical Setting Per the Instructions for Use by the Treating Investigator . [ Time Frame: Intra-procedural ]
Criteria for success:
Investigator Determination if the Flusher can be properly primed. Investigator Determination if the Flusher can be easily connected to current shunt components.
Investigator Determination if the Flusher can be activated.
The following scenarios were also assessed:
A noticeable resistance to compression/collapse of the dome to indicate that the Ventricular Catheter is too tightly blocked to be flushed.
If the dome does not refill the Ventricular Catheter may still be non-flowing. If the dome refills, the flushing procedure may be repeated as needed and/or as determined reasonable by the surgeon.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02651337
|United States, Massachusetts|
|Boston Children's Hospital|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Benjamin Warf, MD Warf, MD||Boston Children's Hospital|