Quality Control: A Prospective Analysis of External Ventricular Drain (EVD) Effectiveness
Phase: NA
Conditions: Catheter Related Infections
Sponsor: University of Oklahoma

IRB NUMBER: 4890
IRB APPROVAL DATE: 12/16/2019
 PI Version
  
IRB version  09/01/2009
1
RESEARCH PROTOCOL OUTLINE
Instructions:  Protocols should be formatted according to the following outline and 
include all of the elements indicated.  
Title of Project: Quality Control: A prospective analysis of external ventricular 
drain effectiveness.
Principal Investigator:
Abdal Cheema, MD, Department of Neurosurgery 
Abstract
In an effort to decrease the number of external ventricular drain (EVD) catheter 
related infections, this research will compare the efficacy of the standard EVD 
catheters utilized by Oklahoma University Medical Center (OUMC).  These 
catheters will be compared in three principle areas: 1) incidence of infection, 2) 
cost analysis, and 3) average durations of placement, without deviation from 
existing standard of care (SOC).  The three EVD catheters being compared in 
this study are 1) the Integra External Drainage Catheter (non-impregnated), 2) 
the Ventriclear EVD Antibiotic Catheters (antibiotic-impregnated), and 3) Codman 
Bactiseal EVD Catheter Set (antibiotic-impregnated).  The goal of this 
prospective study is to determine whether the use of antibiotic impregnated 
EVDs vs non-impregnated EVDs will result in lower infection rates.
A. Specific Aims
The hypothesis for this research study is that antibiotic impregnated EVDs are 
more effective in reducing the number of EVD catheter related infections.  The 
long-term objective is a reduction in the number of EVD catheter related 
infections.
B.  Background and Significance
While use of sterile techniques and periprocedural antibiotics have traditionally 
been used to combat infection, infection rates remain above goal, leading to the 
question of whether the antibiotic impregnated catheter should be added to the 
standard of care.  With the knowledge gained, we hope to decrease the amount 
of EVD catheter related infections and reduce use of prolonged antibiotics.
C.  Preliminary Studies/Progress Report  
Glenn C, Conner A, Cheema AA, Burks J, Case J, O’Neal C, Sughrue M. Use of 
Frameless Neuronavigation for Bedside Placement of External Ventricular 
Catheters. November 28, 2015. PMID 26642952.
Buster B, Bonney P, Cheema AA, Glenn C, Conner A, Safavi S, Andrews M, 
Gross N, Mapstone T. Proximal Ventricular Shunt Malfunctions in Children: 
Factors Associated with Failures. Journal of  Clinical Neuroscience. October 22, 
2015. PMID: 26601815.
D.  Research Design and Methods
All patients, both male and female, ages 18-75, requiring EVD placement will be 
solicited for enrollment into this study, except those who are incarcerated and/or 

IRB NUMBER: 4890
IRB APPROVAL DATE: 12/16/2019
 PI Version
  
IRB version  09/01/2009
2
may be pregnant.  The indications for EVD placement are 1) increased 
intracranial pressure, 2) hydrocephalus, 3) interventricular hemorrhage, and 4) 
subarachnoid hemorrhage with poor clinical exam.  Upon receipt of informed 
consent, participants will be randomly assigned to receive one of the three EVDs 
being studied.  The EVDs being studied are 1) the Integra External Drainage 
Catheter, 2) the Ventriclear EVD Antibiotic Catheter, and 3) Codman Bactiseal 
EVD Catheter Set.  A random number generator will be utilized to randomly 
assign participants to one of three EVDs.  Study data will be collected from 
patient’s electronic medical record (EMR) both at OU Medical Center and OU 
Physicians.  Study data will include participant information, infection outcomes, 
equipment cost, and duration of placement will be added to a secure database 
for later analysis.  The study will enroll a total of 252 participants, after which 
study enrollment will be closed.  The database will be maintained by the Project 
Contact: Beverly Roy, M-HR.  Patients who require placement of an EVD are, by 
nature of their condition (which includes altered mental status), unable to consent 
for the procedure.  As such, a Legally Authorized Representative (LAR) must 
consent for the procedure on behalf of the patient.  The LAR is either the 
patient’s next of kin, or if available, the designee on the patient’s living will, power 
of attorney, or advance directive.  The same LAR will be asked to consent for this 
study, on behalf of the patient.
E.  Statistical Methods  
The statistical method for this study will be a one-way ANOVA.  Utilizing 
G*Power 3.1.9.2 software, a priori power analysis provided the following results:
[1] -- Friday, December 12, 2014 -- 10:25:39
F tests - ANOVA: Fixed effects, omnibus, one-way
Analysis:
A priori: Compute required sample size 
Input:
Effect size f
=
0.25
α err prob
=
0.05
Power (1-β err prob)
=
0.95
Number of groups
=
3
Output:
Noncentrality parameter λ
=
15.7500000
Critical F
=
3.0320649
Numerator df
=
2
Denominator df
=
249
Total sample size
=
252
Actual power
=
0.9514888

IRB NUMBER: 4890
IRB APPROVAL DATE: 12/16/2019
 PI Version
  
IRB version  09/01/2009
3
F.  Gender/Minority/Pediatric Inclusion for Research
This project will include both men and women age 18-75.
G.  Human Participants
1.  This project will recruit 252 participants, age 18-75, who require placement of 
an external ventricular drain.  All adult patients who require an EVD will 
be included.  
2.  Research material will consist of records and data.
3.  Recruitment will take place at the bedside or within a consultation room in the 
OUMC and will be administered by the assigned resident.  The bedside is 
frequently within the emergency department, intensive care unit, or step 
down care unit.  Recruitment of non-English speaking participants will be 
done via a translator.  Given that there is no deviation from the existing 
standard of care, participant coercion is not a significant concern.  
4.  This research does not involve more than minimal risk to the patient.
5.  Patient records, including PHI, will be stored in a secure database on a 
secure network that is password protected.  Access to this database will 
only be granted to essential personnel.
6.  While use of sterile techniques and periprocedural antibiotics have 
traditionally been used to combat infection, infection rates remain above 
goal, leading to the question of whether the antibiotic impregnated 
catheter should be added to the standard of care.  With the knowledge 
gained, we hope to decrease the amount of EVD catheter related 
infections and reduce use of prolonged antibiotics.
7.  The three EVD catheters being studies are part of the existing standard of 
care at OUMC and therefore do not produce any additional risk to the 
patient.
H.  Data and Safety Monitoring Plan 
1.
All electronic data will be maintained in a password protected database on a 
secure server.  All non-electronic data (i.e. consent form) will be stored in a 
locked file cabinet in the Project Contact’s office.
a.
Should any type of breach occur, this will be immediately reported to 
the IRB and study PI.
2.
The study Principal Investigator will be responsible for monitoring the study. 
3.
Additionally, Dr. Bappaditya Ray, Neurologist, will monitor study data.
I.  Literature Cited
Bohnstedt BN, Ziemba-Davis M, Edwards G, Brom J, Payner TD, Leipzig TJ, 
Scott JA, DeNardo AJ, Palmer E, Cohen-Gadol AA.  Treatment and outcomes 
among 102 posterior inferior cerebellar artery aneurysms: a comparison of 
endovascular and microsurgical clip ligation.  World Neurosurg 2014 Dec 23. 
PMID 25541085
Lane B, Bohnstedt BN, Cohen-Gadol AA.  A prospective comparative study of 
microscope-integrated intraoperative fluorescein and indocyanine 
videoangiography for clip ligation of complex cerebral aneurysms.  J 
Neurosurgery; 122(3):618-26, 2015 Mar.  PMID 25526265
Kulwin C, Bohnstedt BN, Payner TD, Leipzig TJ, Scott JA, DeNardo AJ, Cohen-
Gadol AA.  Aneurysmal acute subdural hemorrhage: Prognostic factors 

IRB NUMBER: 4890
IRB APPROVAL DATE: 12/16/2019
 PI Version
  
IRB version  09/01/2009
4
associated with treatment.  J Clin Neurosci 21(8): 1333-6. 2014 Aug PMID 
24679648
Ziemba-Davis M, Bohnstedt BN, Payner TD, Leipzig TJ, Palmer E. Cohen-
Gadol AA. Incidence, epidemiology, and treatment of aneurysmal subarachnoid 
hemorrhage in 12 midwest communities.  J Stroke Cerebrovasc Dis; 23(5): 1073-
82, 2014 May-Jun PMID24144595.
Cohen-Gadol AA. Bohnstedt BN.  Recognition and evaluation of nontraumatic 
subarachnoid hemorrhage and ruptured cerebral aneurysm.  Am Fam Physician; 
88(7): 451-6, 2013 Oct 1 PMID 24134085
Bohnstedt BN, Nguyen HS, Kulwin CG, Shoja MM, Helbig GM, Leipzig TJ, 
Payner TD, Cohen-Gadol AA.  Outcomes for clip ligation and hematoma 
evacuation associated with 102 patients with ruptured middle cerebral artery 
aneurysms.  World Neurosurg 80(3-4):335-41, 2013, PMID 22465372