N/A
N=40
Pilot Testing for Midline Measuring Device
Ventriculo-Peritoneal Shunt Infection
Bottom Line
View on ClinicalTrials.gov: NCT04883060 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcome: Primary: Midline Localization — 0.9 mm
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- midline localizer (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- University of Iowa
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Midline Localization |
0.9 | — |
| SECONDARY Burr Hole Placement |
37 | — |
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).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04883060). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.