Pilot Testing for Midline Measuring Device

Ventriculo-Peritoneal Shunt Infection Clinical Trial

— MMD  

Official title:

Pilot Testing for Midline Measuring Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04883060
• Other study ID #: 201704798
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: July 1, 2019

Study information

• Verified date: January 2024
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Identifying the exact middling on the patient's head during the planning phase of surgery is crucial yet can be challenged by patient's head position and hair. The investigators have invented a device that uses anatomical landmark to quickly and gracefully identify the midline on a patient's head. The device is a U-shaped instrument equipped with a laser pointer at the midline. The instrument also has smooth spheres that can be positioned over the patients' ears bilaterally. The midline laser pointer will identify the midline on the patients' head. this measurement procedure is typically done after the patient is placed under anesthesia. The standard way of determining the midline on the skull is simply by surgeon's vision without any measurements. This new technique will be contrasted against the standard way. The device was invented by investigators in neurosurgery (led by Dr. Matthew Howard III). This is not patented it at this time. There is no company involved in manufacturing (assembly was completed with the help of the hospital's machine shop).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 1, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 85 Years

Eligibility

Inclusion Criteria:

• Patients with normal pressure hydrocephalus who are scheduled to undergo a ventriculoperitoneal shunt surgery

Exclusion Criteria:

• Patients who are not able to consent

Related Conditions & MeSH terms

• Ventriculo-Peritoneal Shunt Infection

Intervention

Device:
• midline localizer
a midline localizer device with a laser pointer is used to localize where the midline is likely to be located on the patient head prior to the surgery.

Locations

Country	Name	City	State
United States	Univeristy of Iowa	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
University of Iowa

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Midline Localization	The average distance separating the staple from the lateral edge of the sagittal sinus	Immediate postop, an average of 4 hours
Secondary	Burr Hole Placement	Number of participants in which their Burr hole placement was between 3 and 4 cm away from anatomical midline	Immediately Post-op, an average of 4 hours