Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT03248739
Study type Interventional
Source Wake Forest University Health Sciences
Contact
Status Terminated
Phase N/A
Start date June 12, 2017
Completion date November 4, 2022

See also
  Status Clinical Trial Phase
Completed NCT05371418 - Comparative Clinical and Radiographical Evaluation of Treatment of Angular Bone Defect Related to Over Erupted Tooth Using GTR Followed by Orthodontic Intrusion Versus Orthodontic Intrusion Followed by GTR N/A
Not yet recruiting NCT05440084 - Impact of CTO PCI (Chronic Total Occlusion Percutaneous Intervention) on Regular Physical Activity
Completed NCT06343454 - The Effect of Different Head Positions on Occlusal Contacts During Digital Interocclusal Bite Registration N/A
Recruiting NCT05507164 - Characterization of the Temporo-masseteric Nerve Block (TMNB) in Healthy Subjects Phase 2
Completed NCT05051878 - Effect of T-scan Occlusal Analysis and Adjustment vs Articulating N/A
Recruiting NCT06365528 - Tunneled Peripherally Inserted Central Catheter (PICC) in Adult Patients and Associated Outcomes N/A
Completed NCT05948254 - Utilized Scan Body Technique For Triple Function N/A
Not yet recruiting NCT06052501 - 3D Evaluation of the Lip Support in a Full-arch Implant-supported Rehabilitations
Completed NCT03332264 - Sequent Please Drug Coated Balloons Versus Primary Stent Application in Long SFA Lesions N/A
Recruiting NCT05780619 - Diagnostic Performance of the Resistance Index (RI) for the Assessment of Cerebral Vasoreactivity in Transcranial Doppler
Completed NCT01131754 - Heparin 100U/L for Prevention of PVC Complications Phase 3
Completed NCT04701970 - Effect of Mandibular Complete Dentures Relining on Occlusal Force Distribution N/A
Not yet recruiting NCT03114722 - Citrate 4% Versus Heparinised Saline in Preventing Peripherally Inserted Central Catheter (PICC) Occlusions Phase 2
Completed NCT05637372 - Relationships Between Anterior and Condylar Guidance - Comparison by CBCT and Electronic Axiography
Not yet recruiting NCT06402045 - Assessment of the Occlusal Characteristics and Orthodontic Treatment Needs for Egyptian Children( 6-12)years Old
Completed NCT01570114 - Covered Metallic Stent and Benign Colonic Strictures Phase 2
Completed NCT04798729 - Comparison of Two Different Digital Methods in Occlusal Analysis
Completed NCT05949151 - Occlusal Forces and Muscle Activity in Fixed Versus Removable Mandibular Implant Supported Overdenture N/A
Completed NCT05490797 - Effects of Mobile Application Dexteria Fine Motor Skills on Hand Dexterity and Grip Strength in Chronic Stroke Patients N/A
Not yet recruiting NCT04940702 - Effectiveness of Focal Vibration and Blood Flow Restriction Within a Multicomponent Exercise Programme. N/A