A Head-to-head Comparison of Catheter Thread Between Two Epidural Kit Vendors.
Phase: NA
Conditions: Labor Pain
Sponsor: University of Michigan

NCT03722446    
Epidural Catheter Thread Between Two Different Vendors 
10/4/2018 
 
 
 
 

A head-to-head comparison of catheter thread between two epidural kit vendors. 
 
Carlo Pancaro *, Baskar Rajala ¶, Christie Vahabzadeh §, Casey Aman $, Ruth Chiware ¥, Tom 
Klumpner ¶, Ruth Cassidy M.S.*, Milo C. Engoren, MD **, Leif Saager, MD** 
 
* Associate Professor, ¶ Assistant Professor, § Obstetric anesthesiology fellow, $ Research 
Assistant, ¥ Instructor, ** Professor of Anesthesiology, Department of Anesthesiology, 
University of Michigan. 
 
From the Departments of Anesthesiology at University of Michigan School of Medicine. 
Address correspondence to: Dr. Pancaro, Department of Anesthesiology, University of 
Michigan, 1500 Medical center drive, Ann Arbor, MI 48109 
Telephone: 734-936-4280 Fax: 734-936-9091; email: cpancaro@med.umich.edu 
Acknowledgements: Supported by departmental funding 
Abbreviated Title: Epidural Catheter Thread 
Primary institution: Division of Obstetric Anesthesiology, von Voigtlander Women’s Hospital. 
 
 
 
 
 

BACKGROUND 
 
Identification of the epidural space involves recognition of a change in pressure from one 
tissue plane to another. This drop of pressure, called “loss of resistance” (LOR), across a band of 
connective tissue into the epidural space is detected using a needle-syringe apparatus. The 
operator applies pressure to the plunger of the syringe until the drop in pressure is identified 
when the plunger collapses. The epidural catheter, a small tube that is inserted into the epidural 
space to give the medication, is then advanced using the needle as a guide. Confidence in 
locating the epidural space is based on clarity of the loss of resistance and the ease of threading 
the epidural catheter.  
 
When there is difficulty in advancing the epidural catheter after the epidural space has 
been identified, several maneuvers are performed in order to correct the problem. These include: 
injecting saline through the needle to “expand” the epidural space, advancing the needle tip 1-2 
mm, inserting a new flexible epidural catheter, inserting a new non-flexible epidural catheter, 
rotating the needle bevel, changing a patient’s posture, pulling the needle back to re-engage the 
ligamentum flavum and then preforming a second LOR technique, and removing the needle 
entirely and preforming a new placement at the same or different interspace (1). Each time a new 
maneuver is preformed, this is considered a new attempt at threading the epidural catheter into 
the epidural space. Not succeeding on threading the epidural catheter correctly into the epidural 
space on the very first try is considered a “failure to thread,” however these maneuvers are 
performed until adequate labor analgesia is established in all patients. Establishing labor 
analgesia on the first epidural catheter threading attempt reduces the amount of time between 
when the epidural is requested and when pain relief is administered. A “more successful” 

epidural threading attempt is related to a decrease in the time required to thread the epidural and 
adequately relieve labor pain. 
 
Difficulty to thread an epidural catheter is distinct from a far more serious complication, 
epidural failure (2). Epidural failure is when the epidural fails to provide adequate pain 
management. Per internal data review, there is no statistically significant difference between 
epidural failure rates in literature (2) and the epidural failure rate on the Labor and Delivery floor 
(9th floor) of the University of Michigan von Voitlander Women’s Hospital.  
 
Two different epidural catheter kits, Arrow FlexTip Plus® Epidural Catheterization Kit 
(Arrow® International, Cleveland, OH) and Perifix® FX Springwound Epidural Catheter Kit 
(B.Braun Medical Inc., Bethlem, PA) are currently in use on the Labor and Delivery floor (9th 
floor) of the University of Michigan von Voitlander Women’s Hospital. Both kits are standard of 
care and are routinely used to place epidurals at von Voitlander. 
 
 

OBJECTIVES 
 
The aim of the study is to assess if there is a difference in ability to thread the epidural 
catheter (measured in time to thread) from two different pain management kits: Arrow® and 
B.Braun®. In order to improve patient care at U of M, if there is a difference in the time to thread 
epidurals with one kit over the other (i.e. one epidural catheter threads more easily than the 
other), we would like to use the kit with decreased time to thread in the future. We would like to 
make this comparison based on data.  
 
Our hypothesis is that there is no difference in the average time required for clinicians to 
thread the epidural catheters from the Arrow® and B.Braun® pain management kits. 
 
The primary outcome is to compare the number of epidural threading attempts between 
the Arrow® and B.Braun® pain management kits. 
 
Secondary objectives of this study are to compare the difference in average time required 
to advance the epidural catheter, the number of epidural needle manipulations once the epidural 
space has been established, the incidence of unintended dural punctures, the incidence of 
paresthesia, and the incidence of epidural intravascular cannulations between the two different 
kit vendors.  
 
Our findings may not be generalizable to other facilities due to local practices (presence 
or absence of trainees, training level of the residents, obesity of patients, etc.) but data will be 
made publically available. This project is primarily intended to improve patient care at U of M 
via scientific level analysis.  
 
 
 

METHODS 
Type of Study 
 
Comparative effectiveness study via an open label alternate treatment design with 
randomized scheduling. 
 
Inclusion Criteria 
The Arrow® and B.Braun® epidural kits available in labor and delivery. 
All patients requesting or requiring epidurals on the 9th floor (Labor and Delivery) of the 
University of Michigan von Voigtlander Women’s Hospital. 
 
 
Exclusion Criteria 
 
Epidural kit not available at the moment of the study. 
 
Randomization Procedure 
 
Epidural kits are available for eligible patients on labor and delivery Von Voiglander 9th 
floor who are requesting labor analgesia. Approximately 30 epidural placements occur in the 
obstetric service during any given week. These epidural placements are consistently performed 
by residents, faculty, and fellows in a sharable and equitable number. No group of individuals are 
specifically targeted.  
 
A prospective alternating intervention study design with randomized weekly scheduling 
will allow for equal use of the two epidural kits. In weeks randomized to Arrow®, only Arrow® 

kits will be available. In weeks randomized to B.Braun®, only B.Braun® epidural kits will be 
available. In order to target a sample size of 240 epidural placements (n=120/group), and 
assuming that every week 30 epidurals will be performed, in 8 weeks we should be able to finish 
the study. However, if at the end of the 8 weeks we have not reached the target sample size per 
kit group, we will continue to randomize kit use in the following weeks in order to achieve 
sufficient sample size. The randomization of the kit to be exclusively used each week will be 
generated through a password-secure computer (www.randomization.com) by the research 
assistant. The two available kits are: 
1) FlexTip Plus® Epidural Catheterization Kit (Arrow® International, Cleveland, OH). 
OR 
2) Multi-orifice epidural kit: Perifix® FX Springwound Epidural Catheter Kit (B.Braun 
Medical Inc., Bethlem, PA).   
However, the alternate pain management kit will remain accessible during the study if it is 
deemed necessary for a particular patient.  
 
This study design is in consideration of the fact that retrospective analyses of large 
databases or patient records are subject to unknown biases, thus causation is difficult to assign. 
(3) (4)  
 
Prestudy Data Collection and Training 
 
All anesthesiologists’ level of expertise (post-graduate year or training) will be collected 
before starting the study as shown in Table 1. Patients’ demographics will be collected and 
selected patient data will be recorded by the provider (see Table 2). This ensures that there are no 

confounding factors in the difference in perceived ability to advance the epidural catheter among 
groups (i.e. morbid obesity or presence of known spinal deformities). This will be done in a 
coded manner, using a numerical code to be assigned to each individual study case. The master 
file will be kept in a locked filing cabinet in the principal investigator’s office. All data will be 
analyzed in a coded fashion. Attention to strict confidentiality will be maintained; no attempts 
will be made to identify individual study subjects. 
 
Equipment, Technique and Study Data Collection 
 
There will be two epidural kits available for the study:  
1) The FlexTip Plus® Epidural Catheterization Kit contains a 17 Gauge Tuohy 
needle, 8.9 cm long and a single open end hole FlexTip Plus® 19 Gauge flexible 
epidural catheter (Arrow International, Cleveland, OH).  
2) The Perifix® FX Springwound Epidural Catheter Kit contains a 17 Gauge 
Espocan® Tuohy needle, 8.9 cm long and a closed tip multiport Perifix® FX 
Springwound 19 Gauge flexible epidural catheter (B.Braun Medical Inc., 
Bethlem, PA).    
Both the Arrow® and B.Braun® epidural catheter kits are currently used at University of 
Michigan. 
 
All patients will be in a sitting position. After standard sterile prep and drape, a wheal of 
local anesthetic will be applied to the interspace.  An epidural Tuohy needle will be advanced 
through the ligamentum flavum. A syringe with saline will be attached to the epidural needle and 

continuous or intermittent pressure will be applied to the syringe plunger until a drop in syringe 
pressure will be noticed (LOR).  
 
Each time a skin wheal of local anesthetic is injected in patients’ lumbar area, this will be 
counted as one epidural attempt. In addition, once loss of resistance has been established, if the 
epidural needle is withdrawn, redirected and re-advanced in order to get loss of resistance again 
because the clinician is not able to advance the epidural catheter, this will be considered as an 
additional epidural attempt.  
 
Once, the epidural catheter has been threaded successfully, the clinician will apply 
negative pressure to the catheter through a syringe in order to rule out blood or cerebro-spinal 
fluid (CSF) aspiration. If aspiration of blood and CSF is negative, the patient will be given our 
standard medications consisting of 2 ml Lidocaine 1.5% with epinephrine 1:200,000 to rule out 
intrathecal catheter placement. Following 2 minutes, the patients will be given additional 3 ml 
from the lidocaine and epinephrine mixture in order to rule out intravascular cannulation. In 
addition, a standard loading bolus of bupivacaine 0.125% with fentanyl 3 mcg/ml will be 
administered in three fractionated doses of 5 ml each, through an epidural pump. All patients will 
be then connected to a programmed intermittent epidural bolus pump with the following settings: 
bupivacaine 0.125% with fentanyl 3 mcg/ml, programmed intermittent bolus 6 ml every 45 
minutes. Patient’s demand bolus 6 ml every 15 minutes, without baseline infusion.   
 
If the epidural catheter cannot be sufficiently advanced into the epidural space, one or 
more of the following maneuvers will be adopted: additional saline will be administered through 
the Tuohy needle; alternatively, a new flexible epidural catheter can be inserted; if the catheter 
advances following one of these afore-mentioned maneuvers, the thread will be considered 
successful with minor adjustments. Conversely, if the needle is rotated, re-angled, redrawn and 

re-advanced or advanced blindly, these will all be considered as major needle manipulations and 
recorded as failure of that attempt to advance the epidural catheter. Further attempts are made 
until proper epidural analgesia is established. 
 
Establishment of successful labor analgesia will be defined at a verbal analogue score 
equal to or less than 10 on a 100-point scale within 30 min from the standard epidural medication 
administration. All data related to the technical aspects of the epidural placement will be 
collected in the form shown in the appendix. The goal of both study groups is the management of 
labor pain. 
 
Waiver of consent justification 
 
A waiver of consent is requested as this study is no more than minimal risk to the study 
population.  
 
When a patient requests an epidural, written consent is required in order for the provider 
to place the epidural. Thus, this study only involves patients who have consented to receive a 
standard of care epidural, as requested by the patient themselves. No patient will be asked to 
undergo an epidural placement procedure that they have not requested. Currently, this written 
consent to an epidural placement procedure at the University of Michigan von Voitlander 
Women’s hospital implies a consent to have an epidural placed using either the Arrow® or 
B.Braun® pain management kit, depending on availability.  
 
By changing to block randomization, this would not be a significant deviation from the 
provider’s choice of pain management kits. The pain management kit available to place an 
epidural at a given time is subject to different influences that do not make it much different from 

random. Most of the time, the provider uses whatever currently available is in the closet, whether 
the Arrow or BBraun kit. 
 
There are logistical difficulties of obtaining informed consent from this vulnerable 
population (pregnant women in all stages of labor): (5)  
(1) Patients in labor (particularly the later stages of labor) are temporarily incapacitated 
and unable to give true informed consent. 
(2) Placing an epidural during labor (particularly the later stages of labor) occurs under 
time constraints where patient comfort is paramount to any research interests. We 
want to prevent any time delays in the anesthesiologist’s administration of the 
requested epidural procedure. 
(3) Approaching laboring patients and requesting that they participate in a research study 
has the potential to incur significant distress in this patient population, especially as 
many are temporarily incapacitated due to labor pain. 
We request a waiver of consent only as we feel that all patients will have received an 
epidural placement procedure that upholds the current standard of care at Von Voigtlander, and 
that this study does not endanger patient safety. Furthermore, should the provider feel that 
participating in this study is not in a patient’s best interest, the provider can proceed using 
whatever pain management kit they feel is best. 
 
We also want to avoid bias. Recruitment sampling of patients in only the early stages of 
labor (rather than all stages of labor) would increase the risk of bias in the study. By sampling 
from all patients who request an epidural, our sample would be an ideal sample since women 
who want to get any form of neuraxial analgesia or anesthesia often decide when they are 

experiencing pain during labor. (6) As labor advances and the laboring parturient experiences 
more pain, it becomes more difficult to place an epidural as the patient may:  
- 
find it difficult to sit in the ideal position for threading an epidural 
- 
find it difficult to remain still for the time required to place the epidural 
We want to sample from an accurate representation of all the scenarios that an anesthesiologist 
provider is called on to administer an epidural, all which necessarily involve threading an 
epidural catheter into the epidural space. 
 
Study Size 
In order to determine the study size, we looked at 114 consecutive epidural placements as 
part of our routine quality assurance with the Arrow® Epidural Catheterization Kit at Von 
Voigtlander. We found that in 11% (n=12) of epidurals placed, the epidural catheter did not 
thread on the first attempt. In a separate quality assurance check we retrospectively reviewed 100 
epidural placements finding out that in 1% (n=1) of epidurals placed, the epidural catheter did 
not thread on the first attempt. A sample-size analysis for the primary outcome shows that 107 
epidural placements per group would provide a power of 80% to detect a difference in proportion 
between the two techniques of 0.10 at the 0.05 level. Considering an attrition of 10-20% for 
follow-up and data missing, a total number of 240 epidural placements will be collected.  Power 
calculations were computed using PASS 14. 
 
Statistical Analysis  
Statistical analysis will be performed using SAS 9.3 (SAS Institute, Cary, NC). The 

primary outcome will be the success rate of epidural catheter threaded with each epidural kit, 
which will be compared by group using a chi-square test or Fisher’s exact test, as appropriate.  
The secondary outcomes will be analyzed as follows: the difference in number of epidural 
attempts will be compared using the Mann-Whitney test; the difference in time to perform the 
epidural start to finish defined as the time the epidural needle is inserted through the patient’s 
skin to the end of the catheter thread will be compared using the Student’s t-test; the difference 
in the incidence of epidural needle manipulations once the epidural space has been established 
will be compared using the Chi-Square or Fisher’s exact test, as appropriate; the difference in 
incidence of unintended dural puncture, paresthesia, and intravascular cannulations will be 
compared using the chi-square or Fisher’s exact test, as appropriate. In addition, the difference in 
unsatisfactory labor analgesia with Arrow® and B.Braun® kits will be compared through the chi-
square or Fisher’s exact test, as appropriate, by looking at the difference in percentages of 
patients who have a verbal analogue pain score equal or less than 10 (scale 0 to 100) at 30 
minutes following epidural medication administration. A p-value of 0.05 throughout will be 
considered statistically significant.  
All statistical analyses will be performed using SAS 9.3 (SAS Institute, Cary, NC). 
 
Minimizing the Risk for Subjects  
 
This project is a comparison of standardized epidural technique between two different 
epidural catheter kits that are currently in use in major academic institutions in the country and at 
the University of Michigan. There is no hypothesized difference in the ability to thread the 

epidural catheter between the two kits. The research involves no risk to the patient subject 
beyond risk inherent to epidural placement. 
 
Waiver of informed consent will not affect the rights, welfare, or pain management of the 
subject, given that in either scenario, they will receive a standard of care epidural.   
 
No identifiable information will be collected and retained about the subjects after 
completion of the patient’s vaginal or cesarean delivery. All data will be recorded using a 
numerical code to be assigned to each individual study case. The master file will be kept in a 
locked filing cabinet in the principal investigator’s office. All data will be analyzed in a coded 
fashion. Attention to strict confidentiality will be maintained; no attempts will be made to 
identify individual study subjects. 
 
Potential Risks of Participation  
The risk of participation is the same as the risks of receiving an epidural catheter for 
analgesia if not enrolled in the study. This study design includes clinical procedures already 
being performed, with the risks the same as standard epidural placement regardless of which 
device is used or physician participation in the study. The overall goal for both study groups 
remains the same: adequate and timely management of labor pain. 
For placement of epidural catheter for analgesia, risks include: 
- Inadequate pain control; likely, but it is not serious as it can be managed with 
additional pain control interventions 

- Persistent headache; infrequent, but it could be more serious and require follow 
up with anesthesiologist 
- Infection; rare, and is serious, requiring additional care by physicians 
- Temporary hip/leg discomfort; likely, but can be managed with additional pain 
control interventions and should go away on its own 
- Low blood pressure; common, but can be treated with additional interventions 
- Decrease in the baby's heart rate; infrequent, but it could be serious and require 
additional interventions 
To minimize any risks, the research team will place epidural catheter according to 
standard clinical protocol including: 
- Ask patients and monitor their pain control and clinical status, performing other 
interventions if needed 
- Use aseptic technique 
Additionally, there may be a loss to confidentiality and privacy. See Minimizing the Risk 
for Subjects for how the study team will minimize these risks. 
As with any procedure, there may be additional risks that are unknown or unexpected but 
rare. 
 
Equitable Selection of Subjects 

All patients receiving epidural analgesia are candidates for this study. There are no 
patient factors that would be grounds for exclusion. No groups of persons based on gender, race, 
or any other distinction will be specifically targeted or excluded. Both epidural kits are current 
standard of care, thus there is no additional risk incurred due to participation in the study. 
 
Costs 
No additional cost will be incurred for the study. 
 
Data and Safety Monitoring Plan 
There are no plans for an independent data and safety monitoring board for this study. 
The principal investigator or the co-investigators will review analysis of all source data for each 
study subject when approximately half (n=120) of the epidural placements are completed. The 
principal investigator and the co-investigator will determine whether the research should be 
altered or stopped on an ongoing basis. 
 
Adverse Event Reporting 
 
The principal investigator will be responsible for reporting all adverse events according 
to the human research committee’s guidelines.   
 
Monitoring and Quality Assurance 

 
The accuracy and completeness of all documents will be monitored on an on-going, 
weekly basis by the principal and co-investigator.  All data will be collected at the time of each 
epidural placement, analyzed for completeness, and filed.  The principal investigator and co-
investigators will follow the validity and integrity of the data and adherence to the IRB approved 
protocol.   
 
 
 
 
 
 

REFERENCES 
1) The incidence and management of inability to advance Arrow FlexTip Plus epidural 
catheters in obstetric patients. Sviggum HP, Farber MK. Int J Obstet Anesth. 2014 
May;23(2):113-7. 
2) Why epidurals do not always work. Arendt K, Segal S. Rev Obstet Gynecol. 2008 
Mar;1(2):49-55. 
3) Effects of volatile anesthetic choice on hospital length of stay: a retrospective study and 
prospective trial. Anesthesia. 2012 July; 199(1):61-70. 
4) Strengthening the Reporting of Observational Studies in Epidemiology 
(STROBE):explanation and elaboration. Vandenbroucke JP, von Elm E, Altman DG, 
Gøtzsche PC, Mulrow CD, Pocock SJ,Poole C, Schlesselman JJ, Egger M; STROBE 
Initiative. Epidemiology. 2007 Nov;18(6):805-35 
5) Exceptions to the rule of informed consent for research with an intervention. Rebers S, 
Aaronson NK, van Leeuwen FE, Schmidt, MK. 2016 Feb; 17(9):1-11 
6) Giving Birth With Epidural Analgesia: The Experience of First-Time Mothers. Hidaka R. 
J Perinat Educ. 2012 
 
 

TABLES  
 
Table 1 Inability to advance epidural catheters according to physician level of training 
Physician level Single-orifice Incidence Multi-orifice Incidence 
Statistics 
First-year 
esident 
x/X (x%) 
 
x/X (x%) 
 
p=  
Second-year 
esident 
x/X (x%) 
 
x/X (x%) 
 
p= 
Third-year 
esident 
x/X (x%) 
 
x/X (x%) 
 
p= 
Fellow 
x/X (x%) 
 
x/X (x%) 
 
p= 
Attending 
x/X (x%) 
 
x/X (x%) 
 
p= 
 
 Data are number (%). 
Table 2 Demographic and Epidural data collection 
Characteristics 
Single-orifice 
N=125) 
Multi-orifice 
N=125) 
P-value 
Demographics 
 
 
 
Age, years 
XX ± X 
XX ± X 
X 
Body Mass Index, kg/m2 
XX ± X 
XX ± X 
X 
Gestational age, weeks 
XX ± X 
XX ± X 
X 
Pain relief within 30 minutes 
X (x%) 
X (x%) 
X 
Cervical dilation (cm) 
XX ± X 
XX ± X 
X 
Catheter failure to advance 
X (x%) 
X (x%) 
X 
Dural puncture epidural 
X (x%) 
X (x%) 
X 
Accidental dural puncture 
X (x%) 
X (x%) 
X 
Paresthesia 
X (x%) 
X (x%) 
X 
Intravascular cannulation 
X (x%) 
X (x%) 
X 
Time to catheter thread 
X (x%) 
X (x%) 
X 
Number of epidural attempts 
X (x%) 
X (x%) 
X 
Epidurals replaced 
X (x%) 
X (x%) 
X 
 
Table 3 Success rates and complications of corrective maneuvers performed 
 
Single-orifice 
Multi-orifice 
 
Maneuver 
Success 
(%) 
Complicatio
ns 
Success 
(%) 
Complicati
ons 
Statistics 
Saline injection 
x/X (x%) 
X 
x/X (x%) 
X 
p=  
Rotate needle bevel 
x/X (x%) 
X 
x/X (x%) 
X 
p= 
New placement 
x/X (x%) 
X 
x/X (x%) 
X 
p= 
Re-engage ligament, re-
advance 
x/X (x%) 
X 
x/X (x%) 
X 
p= 
Advance needle 
x/X (x%) 
X 
x/X (x%) 
X 
p= 
Change needle angle 
x/X (x%) 
X 
x/X (x%) 
X 
p= 
New catheter 
x/X (x%) 
X 
x/X (x%) 
X 
p= 
Data are number (%). 

 
 
 
 

SINGLE vs MULTI-ORIFICE CATHETER STUDY FORM 
 
ANESTHESIOLOGIST CODE  ____Date ____Time ____room ____ 
 
Anesthesiologist :    Attending 
  Fellow     CA-3      CA-2       CA-1 
 
Patient Description  Age: __Gest Age:  __ Ht/Wt:  __   __   G __ P __   
 
Cervical dilation   ___   cm     Estimated Level of placement: L _  -   L _   
 
Relevant patient’s comorbidities: ____________ 
 
EPIDURAL KIT: 
  ARROW  
         BBRAUN 
 
Time: loss of resistance to Epidural needle removed following successful placement  ____ 
minutes : _____seconds 
 
Loss of Resistance      Unable to get Loss           Equivocal Loss         Clear Loss     
 
Dural Puncture epidural used ?    YES    NO 
If Dural Puncture Epidural used, CSF in the spinal needle?    YES    NO 
Dural Puncture Epidural used because of:  ☐ Equivocal loss   ☐ As part of technique    
☐ Because catheter wouldn’t thread and wanted to make sure I was midline 
 
Ease of Threading the Epidural Catheter  
 
 
☐ Easy thread without further maneuvers 
 
☐ hydrodissection, then catheter: 
 
 
 
Thread   Did not thread 
 
☐ new catheter from the same brand, then catheter:   
Thread   Did not thread 
 
☐ Rotated the needle,  then catheter:                          
Thread   Did not thread  
 
☐ Changed needle angle, then catheter: 
             
Thread   Did not thread 
            ☐ Withdrawal and re-advanced the needle with an additional LOR (this count as an 
additional attempt), then catheter:      
 
 
 
Thread   Did not thread 
 
☐ Advanced the needle blindly, then catheter:            
Thread   Did not thread 
 
☐ Changed space 
 
 
Patient Comfort at 30 minutes (VAS ≤ 10/100)  YES   
NO 
 
Additional Number of attempts after loss of resistance       0    1    2     3    4    5  
Complications   (circle all that applies) 
Wet tap 
      Paresthesias              Intravascular 
      Other (please explain) 
 
Epidural analgesia failed and then epidural Replaced? YES 
 
NO 
Delivery date _____ and Time _________