Comparison of EVD Catheter Diameter on Occlusion and Replacement

Occlusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03248739
• Other study ID #: IRB00042079
• Status: Terminated
• Phase: N/A
• Start date: June 12, 2017
• Est. completion date: November 4, 2022

Study information

• Verified date: October 2022
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 33
• Est. completion date: November 4, 2022
• Est. primary completion date: November 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

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.

Related Conditions & MeSH terms

• Occlusion

Intervention

Device:
• Clear Bactiseal 'large' catheter (EVD)
Antibiotic-impregnated 'large' catheter (inner diameter 1.9 mm, outer diameter 3.4 mm)
• Orange Bactiseal 'small' catheter (EVD)
Antibiotic-impregnated 'small' catheter (inner diameter 1.5 mm, outer diameter 3 mm)

Locations

Country	Name	City	State
United States	Wake Forest Baptist Health	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

References & Publications (12)

Abla AA, Zabramski JM, Jahnke HK, Fusco D, Nakaji P. Comparison of two antibiotic-impregnated ventricular catheters: a prospective sequential series trial. Neurosurgery. 2011 Feb;68(2):437-42; discussion 442. doi: 10.1227/NEU.0b013e3182039a14. — View Citation

Bauer DF, McGwin G Jr, Melton SM, George RL, Markert JM. The relationship between INR and development of hemorrhage with placement of ventriculostomy. J Trauma. 2011 May;70(5):1112-7. doi: 10.1097/TA.0b013e3181e7c2ae. — View Citation

Bogdahn U, Lau W, Hassel W, Gunreben G, Mertens HG, Brawanski A. Continuous-pressure controlled, external ventricular drainage for treatment of acute hydrocephalus--evaluation of risk factors. Neurosurgery. 1992 Nov;31(5):898-903; discussion 903-4. doi: 10.1227/00006123-199211000-00011. — View Citation

Chi H, Chang KY, Chang HC, Chiu NC, Huang FY. Infections associated with indwelling ventriculostomy catheters in a teaching hospital. Int J Infect Dis. 2010 Mar;14(3):e216-9. doi: 10.1016/j.ijid.2009.04.006. Epub 2009 Jul 31. — View Citation

Fichtner J, Guresir E, Seifert V, Raabe A. Efficacy of silver-bearing external ventricular drainage catheters: a retrospective analysis. J Neurosurg. 2010 Apr;112(4):840-6. doi: 10.3171/2009.8.JNS091297. — View Citation

Gilard V, Djoubairou BO, Lepetit A, Metayer T, Gakuba C, Gourio C, Derey S, Proust F, Emery E, Gaberel T. Small versus Large Catheters for Ventriculostomy in the Management of Intraventricular Hemorrhage. World Neurosurg. 2017 Jan;97:117-122. doi: 10.1016/j.wneu.2016.09.105. Epub 2016 Oct 10. — View Citation

Kakarla UK, Kim LJ, Chang SW, Theodore N, Spetzler RF. Safety and accuracy of bedside external ventricular drain placement. Neurosurgery. 2008 Jul;63(1 Suppl 1):ONS162-6; discussion ONS166-7. doi: 10.1227/01.neu.0000335031.23521.d0. — View Citation

Khanna RK, Rosenblum ML, Rock JP, Malik GM. Prolonged external ventricular drainage with percutaneous long-tunnel ventriculostomies. J Neurosurg. 1995 Nov;83(5):791-4. doi: 10.3171/jns.1995.83.5.0791. — View Citation

Olson DM, Zomorodi M, Britz GW, Zomorodi AR, Amato A, Graffagnino C. Continuous cerebral spinal fluid drainage associated with complications in patients admitted with subarachnoid hemorrhage. J Neurosurg. 2013 Oct;119(4):974-80. doi: 10.3171/2013.6.JNS122403. Epub 2013 Aug 20. — View Citation

Rahman M, Whiting JH, Fauerbach LL, Archibald L, Friedman WA. Reducing ventriculostomy-related infections to near zero: the eliminating ventriculostomy infection study. Jt Comm J Qual Patient Saf. 2012 Oct;38(10):459-64. doi: 10.1016/s1553-7250(12)38061-6. — View Citation

Rosenbaum BP, Vadera S, Kelly ML, Kshettry VR, Weil RJ. Ventriculostomy: Frequency, length of stay and in-hospital mortality in the United States of America, 1988-2010. J Clin Neurosci. 2014 Apr;21(4):623-32. doi: 10.1016/j.jocn.2013.09.001. — View Citation

Tse Ts, Cheng K, Wong K, Pang K, Wong C. Ventriculostomy and Infection: A 4-year-review in a local hospital. Surg Neurol Int. 2010 Sep 9;1:47. doi: 10.4103/2152-7806.69033. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 4 weeks
Secondary	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.	Up to 4 weeks
Secondary	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.	Up to 4 weeks
Secondary	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.	48 hours after placement.
Secondary	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).	Up to 4 weeks