Trial Outcomes & Findings for Pilot Testing for Midline Measuring Device (NCT NCT04883060)

Results Overview

The average distance separating the staple from the lateral edge of the sagittal sinus

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

Immediate postop, an average of 4 hours

Results posted on

2024-01-30

Participant milestones
Measure	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.
Overall Study STARTED	40
Overall Study COMPLETED	40
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort
Measure	Intervention n=40 Participants 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.
Age, Categorical <=18 years	0 Participants n=40 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=40 Participants
Age, Categorical >=65 years	24 Participants n=40 Participants
Sex: Female, Male Female	26 Participants n=40 Participants
Sex: Female, Male Male	14 Participants n=40 Participants
Region of Enrollment United States	40 Participants n=40 Participants

Timeframe: Immediate postop, an average of 4 hours

The average distance separating the staple from the lateral edge of the sagittal sinus

Outcome measures
Measure	Intervention n=40 Participants 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.
Midline Localization	0.9 mm Standard Deviation 1.6

Timeframe: 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

Outcome measures
Measure	Intervention n=40 Participants 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.
Burr Hole Placement	37 Participants

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Intervention n=40 participants at risk 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.
Surgical and medical procedures Incorrect Burr Hole Placement	7.5% 3/40 • Number of events 3 • From the start of surgery until surgical closure, up to 2.5 hours
Surgical and medical procedures Ventricle Catheter Misplacement	2.5% 1/40 • Number of events 1 • From the start of surgery until surgical closure, up to 2.5 hours

University of Iowa

Phone: (319) 356-8468