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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Patients undergoing ventriculoperitoneal surgery where the midline localizer was used |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| midline localizer | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Midline Localization | The average distance separating the staple from the lateral edge of the sagittal sinus | Immediate postop, an average of 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univeristy of Iowa | Iowa City | Iowa | 52242 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Midline Localization | The average distance separating the staple from the lateral edge of the sagittal sinus | Posted | Mean | Standard Deviation | mm | Immediate postop, an average of 4 hours |
|
|
From the start of surgery until surgical closure, up to 2.5 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Incorrect Burr Hole Placement | Surgical and medical procedures | Systematic Assessment | Burr hole was not between 3 and 4 cm away from anatomical midline |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Matthew Howard III | University of Iowa | (319) 356-8468 | matthew-howard@uiowa.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 10, 2017 | Sep 10, 2021 | Prot_SAP_000.pdf |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
| Secondary | Burr Hole Placement | Number of participants in which their Burr hole placement was between 3 and 4 cm away from anatomical midline | Posted | Count of Participants | Participants | Immediately Post-op, an average of 4 hours |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 4 |
| 40 |
|
| Ventricle Catheter Misplacement | Surgical and medical procedures | Systematic Assessment | Catheter tip entered the parenchyma at the level of gyrus fasciolaris |
|
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