Comparison of EVD Catheter Diameter on Occlusion and Replacement

October 23, 2023 updated by: Wake Forest University Health Sciences

A Comparison of External Ventricular Drain Catheter Diameter on Occlusion and Replacement: A Randomized Trial

A randomized trial comparing small versus large catheters in terms of occlusion and need for replacement to confirm differential occlusion risk based on catheter size. This study will be done to determine whether external ventricular drain catheter diameter has any effect on risk of occlusion.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Ventriculostomy is a common neurosurgical procedure. A Nationwide Inpatient Sample (NIS) database study demonstrated a significant increase in ventriculostomy utilization from 1988-2010, with over 35,000 hospitalizations including a procedural code for ventriculostomy in 2010.

Ventriculostomy occlusion is a common complication after external ventricular drain (EVD) placement. A review of published prospective and retrospective studies indicates that approximately 1-7% of EVDs require replacement secondary to occlusion. Furthermore, in the NIS database study of over 101,000 hospitalizations in which ventriculostomy was performed, nearly 6% of patients required at least one additional ventriculostomy procedure. Studies have demonstrated non-patent EVD in 19-47% of patients, however these studies did not prospectively evaluate EVD occlusion as a primary endpoint, report on number of catheter irrigations performed, or identify risk factors for EVD occlusion.

Recently, the investigators completed a retrospective review of a prospectively collected database of patients undergoing bedside EVD placement with the primary outcome of interest being catheter occlusion. This sample included 101 patients over a 1 year period. Two Codman catheters were available for use (Clear Bactiseal 'large' catheter: outer diameter 3.4 mm, inner diameter 1.9 mm; and Orange Bactiseal 'small' catheter: outer diameter 3 mm, inner diameter 1.5 mm). The decision regarding which catheter to use was made at the time of the procedure based on resident preference and availability. Both temporary occlusion (requiring flushing but patency could be restored) and permanent catheter occlusion (requiring replacement) were common, occurring in 41% and 19% of patients, respectively. Over 25% of small catheters became occluded during the study period compared to 11% of large catheters. Small catheters were associated with a 3.4 times greater odds of occlusion than the larger diameter catheters on multivariable regression analysis. This study suggests that the preferential use of larger diameter catheters may reduce the risk of ventriculostomy occlusion and need for replacement, however the study was not randomized and catheter selection may have been biased.

Recently, a smaller retrospective study of patients with intraventricular hemorrhage performed by Gilard and colleagues demonstrated a lower rate of occlusion and no increased risk of hemorrhage with larger bore catheters. Otherwise, there is no data in the literature supporting the preferential use of catheters based on size (clinical equipoise).

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27104
        • Wake Forest Baptist Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult patients (18-85 years old) with a Glasgow Coma Scale (GCS) score of 7 or higher requiring frontal EVD placement.
  • Diagnoses: spontaneous subarachnoid hemorrhage, intraventricular hemorrhage, intraparenchymal or cerebellar hemorrhage due to aneurysm, arteriovenous malformation, arteriovenous fistula, hypertension, or idiopathic etiology.
  • Also included are patients for whom the attending neurosurgeon decides that frontal EVD placement is indicated for patient treatment with planned cerebrospinal fluid (CSF) drainage for 72 hours or more.

Exclusion Criteria:

  • GCS of 6 or less
  • Hunt and Hess subarachnoid hemorrhage grade of 5.
  • Age 86 or greater, or age 17 or less.
  • Patient cannot consent and next of kin cannot consent prior to procedure.
  • Diagnosis of traumatic brain injury, as the EVD is often clamped for extended periods of time.
  • Patients anticoagulated prior to admission with warfarin, Effient, Plavix, therapeutic heparin infusion, therapeutic subcutaneous lovenox, therapeutic subcutaneous arixtra, or other therapeutic anticoagulant or antiplatelet agent (ASA not included).
  • Plan for EVD placement through non-frontal burr hole.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Clear Bactiseal 'large' catheter (EVD)
All EVDs will be placed by neurological surgeons in either the major operating suite or in an ICU setting using a previously published protocol. This protocol includes using a burr hole entry point 1 cm anterior to the coronal suture in the mid-pupillary line, prep and sterile drape, pre-procedural antibiotic administration, and tunneling the catheter to an exit site at least 5 cm from the incision. In general, physicians are instructed to first attempt distal irrigation of the drainage chamber using sterile techniques (rarely effective), followed by gentle aspiration of the proximal system and catheter if distal flushing is not effective. If these do not restore patency, a small volume of sterile saline, 3 ml or less, is flushed proximally into the catheter. Patency is checked by lowering the EVD drainage system and evaluating for spontaneous flow through the EVD.
Device: Clear Bactiseal 'large' catheter (EVD)
Antibiotic-impregnated 'large' catheter (inner diameter 1.9 mm, outer diameter 3.4 mm)
Active Comparator: Orange Bactiseal 'small' catheter (EVD)
All EVDs will be placed by neurological surgeons in either the major operating suite or in an ICU setting using a previously published protocol. This protocol includes using a burr hole entry point 1 cm anterior to the coronal suture in the mid-pupillary line, prep and sterile drape, pre-procedural antibiotic administration, and tunneling the catheter to an exit site at least 5 cm from the incision. In general, physicians are instructed to first attempt distal irrigation of the drainage chamber using sterile techniques (rarely effective), followed by gentle aspiration of the proximal system and catheter if distal flushing is not effective. If these do not restore patency, a small volume of sterile saline, 3 ml or less, is flushed proximally into the catheter. Patency is checked by lowering the EVD drainage system and evaluating for spontaneous flow through the EVD.
Device: Orange Bactiseal 'small' catheter (EVD)
Antibiotic-impregnated 'small' catheter (inner diameter 1.5 mm, outer diameter 3 mm)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Permanent Catheter Occlusions
Time Frame: Up to 4 weeks
This is defined by a non-functioning (non-patent) EVD where patency cannot be restored through catheter manipulation or flushing.
Up to 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Catheter Replacements
Time Frame: Up to 4 weeks
Defined by replacement of the ipsilateral EVD due to permanent occlusion, or placement of a contralateral EVD in the setting of a non-functioning ipsilateral catheter. Catheters placed contralaterally in the setting of a functioning ipsilateral catheter will not be considered replacements.
Up to 4 weeks
Number of Participants With Temporary Occlusions
Time Frame: Up to 4 weeks
Defined by non-functioning (non-patent) catheter requiring neurosurgeon flushing or manipulation in order to restore patency. By definition, such maneuvers must restore patency of the EVD such that it is functioning normally afterwards. Multiple temporary occlusions may be possible.
Up to 4 weeks
Number of Participants With Procedure-related Hemorrhages
Time Frame: 48 hours after placement.
Presence of new catheter-related intraparenchymal hemorrhage, subdural hematoma, or intraventricular hemorrhage on CT scan 48 hours after placement.
48 hours after placement.
Number of Participants With Symptomatic Hemorrhages
Time Frame: Up to 4 weeks
Presence of new neurologic deficits as a result of EVD-related hemorrhage, or resulting in need for further procedures due to new EVD-related hemorrhage (craniotomy for hematoma evacuation, ICP monitoring, etc).
Up to 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Investigators

  • Principal Investigator: Kyle M Fargen, MD, Assistant Professor, Surgery Neurosurgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 12, 2017

Primary Completion (Actual)

November 4, 2022

Study Completion (Actual)

November 4, 2022

Study Registration Dates

First Submitted

August 4, 2017

First Submitted That Met QC Criteria

August 9, 2017

First Posted (Actual)

August 14, 2017

Study Record Updates

Last Update Posted (Actual)

October 25, 2023

Last Update Submitted That Met QC Criteria

October 23, 2023

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB00042079

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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