Quantitative Characterization of Safe Irrigation for Ventricular Shunt Catheters

Hydrocephaly Clinical Trial

Official title:

Quantitative Characterization of Safe Irrigation for Ventricular Shunt Catheters

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02651337
• Other study ID #: P000009795
• Status: Completed
• Phase: N/A
• Start date: April 1, 2016
• Est. completion date: June 14, 2016

Study information

• Verified date: August 2020
• Source: Alcyone Lifesciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this pilot study is to perform a set of pressure and flow rate measurements in order to quantitatively characterize safe irrigation or "flushing" of a ventricular shunt catheter, a routine maneuver performed by a neurosurgeon during a shunt revision surgery. This maneuver involves injecting saline with a syringe to clear plugged shunt catheters. Based on data obtained in Stage I of the study, a device has been fabricated which provides the same small-volume pulse of fluid used by surgeons. In Stage II of the study, pressure and flow rate measurements generated by this specialized flusher device will be collected and measured.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: June 14, 2016
• Est. primary completion date: June 4, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 35 Years

Eligibility

Inclusion Criteria:

1. Subjects must be 30 days to 35 years of age, of any race or gender.

2. Subjects must be scheduled to undergo a neurosurgical procedure potentially requiring a revision of neurosurgical catheters.

3. Subjects aged >18 years of age must be willing and able to provide written informed consent. Parental consent will be required for minors.

Exclusion Criteria:

1. Inability or unwillingness of subject or parent/guardian to give informed consent/assent.

2. Judgment of the investigator, surgeon, or any member of the care team (including anesthesiology or operating room nursing staff) that participation in the study will interfere with, or be detrimental to, administration of optimal healthcare of the subject.

3. Inability or unwillingness of subject to endure the test or any other condition that would preclude or bias the results of the study according to the judgment of the investigator.

Related Conditions & MeSH terms

• Hydrocephalus
• Hydrocephaly

Intervention

Device:
• Cerebrospinal Fluid (CSF) Drainage
Placement of Alivio in line flusher during CSF drainage

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Alcyone Lifesciences, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (2)

Boop FA, Medhkour A, Honeycutt J, James C, Cherny WB, Duntsch C. In vitro testing of current spread during ventricular catheter coagulation using diathermy. Technical note. J Neurosurg. 2007 Feb;106(2 Suppl):165-8. — View Citation

Naradzay JF, Browne BJ, Rolnick MA, Doherty RJ. Cerebral ventricular shunts. J Emerg Med. 1999 Mar-Apr;17(2):311-22. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 .	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.	Intra-procedural

External Links

•   Book Chapter: ISBN13: 9781588905109