Occlusion
Conditions
Keywords
Catheter, Ventricular, External Ventricular Drain Catheter, EVD Catheter, Occlusion, Ventriculostomy, Clear Bactiseal catheter, Orange Bactiseal catheter, Ventriculostomy Occlusion, Neurosurgery
Brief summary
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.
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).
Interventions
Antibiotic-impregnated 'large' catheter (inner diameter 1.9 mm, outer diameter 3.4 mm)
Antibiotic-impregnated 'small' catheter (inner diameter 1.5 mm, outer diameter 3 mm)
Sponsors
Study design
Eligibility
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Permanent Catheter Occlusions | Up to 4 weeks | This is defined by a non-functioning (non-patent) EVD where patency cannot be restored through catheter manipulation or flushing. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Catheter Replacements | 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. |
| Number of Participants With Temporary Occlusions | 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. |
| Number of Participants With Procedure-related Hemorrhages | 48 hours after placement. | Presence of new catheter-related intraparenchymal hemorrhage, subdural hematoma, or intraventricular hemorrhage on CT scan 48 hours after placement. |
| Number of Participants With Symptomatic Hemorrhages | 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). |
Countries
United States
Participant flow
Pre-assignment details
33 subjects were consented to study with 33 being randomized.
Participants by arm
| Arm | Count |
|---|---|
| Large Large Bore Catheter (1.9mmID) | 17 |
| Small Small Bore Catheter (1.5mm ID) | 16 |
| Total | 33 |
Baseline characteristics
| Characteristic | Large | Total | Small |
|---|---|---|---|
| Age, Continuous | 58.8 years STANDARD_DEVIATION 13.9 | 60.5 years STANDARD_DEVIATION 13.4 | 62.1 years STANDARD_DEVIATION 13.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants | 33 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 6 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 13 Participants | 26 Participants | 13 Participants |
| Region of Enrollment United States | 17 participants | 33 participants | 16 participants |
| Sex: Female, Male Female | 10 Participants | 19 Participants | 9 Participants |
| Sex: Female, Male Male | 7 Participants | 14 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 16 |
| other Total, other adverse events | 0 / 17 | 0 / 16 |
| serious Total, serious adverse events | 0 / 17 | 0 / 16 |
Outcome results
Number of Participants With Permanent Catheter Occlusions
This is defined by a non-functioning (non-patent) EVD where patency cannot be restored through catheter manipulation or flushing.
Time frame: Up to 4 weeks
Population: Randomized to Large or Small Bore Catheters
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Large | Number of Participants With Permanent Catheter Occlusions | 0 Participants |
| Small | Number of Participants With Permanent Catheter Occlusions | 2 Participants |
Number of Participants With Catheter Replacements
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.
Time frame: Up to 4 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Large | Number of Participants With Catheter Replacements | 1 Participants |
| Small | Number of Participants With Catheter Replacements | 3 Participants |
Number of Participants With Procedure-related Hemorrhages
Presence of new catheter-related intraparenchymal hemorrhage, subdural hematoma, or intraventricular hemorrhage on CT scan 48 hours after placement.
Time frame: 48 hours after placement.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Large | Number of Participants With Procedure-related Hemorrhages | 0 Participants |
| Small | Number of Participants With Procedure-related Hemorrhages | 0 Participants |
Number of Participants With Symptomatic Hemorrhages
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).
Time frame: Up to 4 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Large | Number of Participants With Symptomatic Hemorrhages | 0 Participants |
| Small | Number of Participants With Symptomatic Hemorrhages | 0 Participants |
Number of Participants With Temporary Occlusions
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.
Time frame: Up to 4 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Large | Number of Participants With Temporary Occlusions | 2 Participants |
| Small | Number of Participants With Temporary Occlusions | 0 Participants |