Pilot Testing for Midline Measuring Device

Not Applicable

Completed

• Conditions: Ventriculo-Peritoneal Shunt Infection
• Interventions: Device: midline localizer

• Registration Number: NCT04883060
• Lead Sponsor: University of Iowa

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2019-07-01
• Study Completion: 2019-07-01
• Study First Submitted: 2021-05-06
• Study First Submitted QC: 2021-05-06
• Study First Posted: 2021-05-12
• Results First Submitted: 2023-02-17
• Status Verified: 2024-01
• Results First Submitted QC: 2024-01-04
• Last Update Submitted: 2024-01-04
• Results First Posted: 2024-01-30
• Last Update Posted: 2024-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	midline localizer	Patients undergoing ventriculoperitoneal surgery where the midline localizer was used

Primary Outcome Measures

Name	Time	Method
Midline Localization	Immediate postop, an average of 4 hours	The average distance separating the staple from the lateral edge of the sagittal sinus

Secondary Outcome Measures

Name	Time	Method
Burr Hole Placement	Immediately Post-op, an average of 4 hours	Number of participants in which their Burr hole placement was between 3 and 4 cm away from anatomical midline

Trial Locations

Locations (1)

Univeristy of Iowa; 🇺🇸 Iowa City, Iowa, United States