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A Prospective Clinical Trial to Evaluate an Automated Cerebral Ventricular Drainage System in Patients in the Neurointensive Care

NCT05177692 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-01-31

No results posted yet for this study

Summary

This is a prospective, randomised trial to evaluate a new medical device for automated zero calibration of ventricular drainage systems in neurointensive care patients.

Patients will be randomised into the medical device group, or a control group with a standard system for ventricular drainage.

All patients will be fitted with an intraparenchymal ICP monitor, and an ICP monitor connected to the ventricular catheter.

Since ICP monitoring using the ventricular catheter system is reliant upon regular zero-calibrations of the system in relation to the mid-point of the patient head, the ICP value from the intraparenchymal ICP monitor will be used as standard, and the intra-ventricular ICP measurements will be compared to this ICP.

The difference in ICP between the two ICP monitors will be the primary outcome for this trial, where the medical device tested is designed to constantly zero-calibrate the ventricular catheter in relation to the patients´ head.

Secondary outcome of this trial will be number of manual zero-calibrations performed, and number of automated zero-calibrations performed by the device, and AE, SAE and DDs.

Conditions

  • ICP Regulation Using a New Device for Automated Zero-calibration for a Ventricular Drainage System

Interventions

DEVICE

Vguard

VGuard is a system that has been created to ensure that the patients´ ventricular drainage system and pressure monitor closely follows the patient when the head is adjusted vertically. The system consists of a pressure sensor that is connected to the patients´ head. The pressure sensor is connected to a motorized column that automatically adjusts to keep the zero level at level with the patients´ head at all times.

Sponsors & Collaborators

  • Skane University Hospital

    lead OTHER

Principal Investigators

  • Niklas Marklund, Professor · Professor of Neurosurgery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-29
Primary Completion
2024-03-12
Completion
2024-03-12

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05177692 on ClinicalTrials.gov