Ventriculo-Peritoneal Shunt Infection
Conditions
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).
Interventions
DEVICEmidline 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.
Sponsors
University of Iowa
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Midline Localization | Immediate postop, an average of 4 hours | The average distance separating the staple from the lateral edge of the sagittal sinus |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Patients undergoing ventriculoperitoneal surgery where the midline localizer was used
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. | 40 |
| Total | 40 |
Baseline characteristics
| Characteristic | Intervention | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 24 Participants | — |
| Age, Categorical Between 18 and 65 years | 16 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 40 Participants | — |
| Sex: Female, Male Female | 26 Participants | — |
| Sex: Female, Male Male | 14 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 40 |
| other Total, other adverse events | 4 / 40 |
| serious Total, serious adverse events | 0 / 40 |
Outcome results
Primary
Midline Localization
The average distance separating the staple from the lateral edge of the sagittal sinus
Time frame: Immediate postop, an average of 4 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Midline Localization | 0.9 mm | Standard Deviation 1.6 |
Secondary
Burr Hole Placement
Number of participants in which their Burr hole placement was between 3 and 4 cm away from anatomical midline
Time frame: Immediately Post-op, an average of 4 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Burr Hole Placement | 37 Participants |