Assessment of the Accuracy of the Manual Palpation of Surface Landmarks Versus Ultrasound for Identification of the Correct Intervertebral Space for Spinal Anesthesia in Children Less Than 1 Year of Age
Phase: NA
Conditions: Anesthesia, Local, Infant Conditions
Sponsor: Nationwide Children's Hospital

Assessment of the accuracy of the manual palpation of surface landmarks 
versus ultrasound for identification of the correct intervertebral space for 
spinal anesthesia in children less than 1 year of age 
 
 
NCT04757805 
 
 
July 8, 2021 

PROTOCOL TITLE: Accuracy of manual palpation vs ultrasound for spinal anesthesia in 
children less than 1 year of age.  
 
 
Page 1 of 9 
HRP-503  v.12.10.18 
PROTOCOL TITLE: Assessment of the accuracy of the manual palpation of 
surface landmarks versus ultrasound for identification of the correct intervertebral space 
for spinal anesthesia in children less than 1 year of age.  
 
PRINCIPAL INVESTIGATOR: 
Name: Giorgio Veneziano, MD 
Department/Center: Anesthesiology & Pain Medicine 
Telephone Number: 614-722-4200 
Email Address: Giorgio.Veneziano@nationwidechildrens.org 
 
VERSION NUMBER/DATE: ver. 3/July 8, 2021 
 
REVISION HISTORY 
 
Revision 
# 
Version Date 
Summary of Changes 
Consent 
Change? 
1 
3/17/2021 
Adding L3-4 to L4-5 as the appropriate 
interspace, changing attending anesthesiologist 
to clinical anesthesia provider (fellow or 
attending), clarifying research anesthesiologist 
performing ultrasound, collecting data on years 
of experience for clinical provider, removing 
lateral position from the conus medullaris 
measurement. 
No 
2 
7/1/2021 
Changing the PI from Dr. Dontukurthy to Dr. 
Veneziano, 17.3 - revised the record retention 
details to six years. 
Yes 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

PROTOCOL TITLE: Accuracy of manual palpation vs ultrasound for spinal anesthesia in 
children less than 1 year of age.  
 
 
Page 2 of 9 
HRP-503  v.12.10.18 
1.0 
Study Summary 
 
Study Title 
Assessment of the accuracy of the manual palpation of 
surface landmarks versus ultrasound for identification of the 
correct intervertebral space for spinal anesthesia in children 
less than 1 year of age. 
Study Design 
Prospective study 
Primary Objective 
The primary objective of the study is to compare the 
accuracy of manual palpation of surface landmarks versus 
ultrasonography for identification of the appropriate 
interspace for lumbar puncture and spinal anesthesia in 
infants less than 1 year of age. 
Secondary 
Objective(s) 
The secondary objective is to assess the level of the conus 
medullaris in infants in the sitting and lateral position. 
Research 
Intervention(s)/ 
Investigational 
Agent(s)  
Ultrasound  
IND/IDE #  
N/A 
Study Population 
Main OR surgical patients 
Sample Size 
50 
Study Duration for 
individual 
participants 
Less than 30 minutes total. 
Study Specific 
Abbreviations/ 
Definitions  
N/A 
 
2.0 
Objectives 
2.1 The primary objective of the study is to compare the accuracy of manual 
palpation of surface landmarks versus ultrasonography for identification of 
the appropriate interspace for lumbar puncture and spinal anesthesia in 
infants less than 1 year of age. 
2.2 The secondary objective is to assess the level of the conus medullaris in 
infants in the lateral position and also in the sitting position. 
2.3 The hypothesis is that ultrasonography will be more accurate than the 
traditional method of palpation of surface landmarks in the identification of 
the appropriate interspace for lumbar puncture and spinal anesthesia in 
children less than 1 year of age. 
3.0 
Background  
3.1  Spinal anesthesia may be used instead of general anesthesia in children for 
lower abdominal surgical procedures. The conus medullaris ends at L3-L4 in 
children less than 1 year of age and therefore the L3-4 or L4-5 interspace is 

PROTOCOL TITLE: Accuracy of manual palpation vs ultrasound for spinal anesthesia in 
children less than 1 year of age.  
 
 
Page 3 of 9 
HRP-503  v.12.10.18 
suggested as the optimal site for lumbar puncture for spinal anesthesia. 
Manual palpation is commonly performed to identify the correct 
intervertebral space for spinal anesthesia. Studies in adults and children have 
shown that manual palpation can be inaccurate in up to 30% of cases.1-3 
Traumatic needle placement or the administration of a concentrated local 
anesthetic agent into the spinal cord can lead to serious morbidity including 
neurologic damage and even paraplegia.2,4 Ultrasonography may be used to 
assess the intervertebral space prior to spinal anesthesia in adults especially 
in difficult cases and in children to locate the tip of epidural catheter. 
Introduction of the ultrasound for assessment of the correct intervertebral 
space for spinal anesthesia may decrease the number of attempts and the 
possibility the incidence of serious adverse effects. 
 
4.0 
Study Endpoints  
4.1 The accuracy of manual palpation of surface landmarks for identification of 
the appropriate interspace (L3-4/L4-5) for lumbar puncture and spinal 
anesthesia. 
4.2 The level of the conus medullaris lateral and sitting. 
 
5.0 
Study Intervention/Investigational Agent 
5.1 The only intervention being used that is not normally used in general clinical 
practice is the use of ultrasonography.  The technique is non-invasive and 
poses no risk. Ultrasonography will be performed by an anesthesiologist with 
training and experience and will add less than 10 minutes to the anesthetic 
time. 
 
6.0 
Procedures Involved*  
6.1  Anesthetic management will not vary from the standard technique and will 
be at the discretion of the anesthesia team. The clinical anesthesia provider 
(fellow or attending) who will be performing spinal anesthesia will mark the 
interspace for spinal anesthesia with a marking pen. The study team will 
record the providers years of experience performing spinal anesthesia.  The 
research anesthesiologist performing the ultrasound will confirm whether or 
not the appropriate interspace (L3-4/L4-5) has been identified. Also, the 
interspace where the conus medullaris ends will be identified in the sitting 
position. Spinal anesthesia will be performed at the space confirmed by 
ultrasound using our standard clinical care.  
 
7.0  
Data and Specimen Banking* 
N/A 
 
8.0  
Sharing of Results with Subjects* 
Results will not be shared 

PROTOCOL TITLE: Accuracy of manual palpation vs ultrasound for spinal anesthesia in 
children less than 1 year of age.  
 
 
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HRP-503  v.12.10.18 
9.0  
Study Timelines* 
• 
An individual study subject’s participation in the study should last 
approximately 15-30 minutes total.  
• 
All study subjects should be enrolled within 1 year of study start. 
• 
The study should be completed within 2 years of study start.  
10.0 Inclusion and Exclusion Criteria* 
10.1 Potential subjects will be identified by reviewing the surgery schedule in 
Epic and will be recruited from the Surgery Unit pre-op area prior to their 
surgery.   
10.2 Inclusion criteria: Patients less than 1 year of age scheduled for spinal 
anesthesia for elective lower abdominal, urologic, or lower extremity 
surgery at Nationwide Children’s Hospital.  
10.3  Exclusion criteria:  
Parents unwilling for their children to undergo spinal anesthesia for surgery.  
Children with known spinal anomalies including sacral dimple. 
Children with coagulation abnormalities or receiving anticoagulation which 
precludes the use of spinal anesthesia. 
Children with superficial or deep infections over the spine which precludes 
the use of spinal anesthesia.  
 
11.0 Vulnerable Populations* 
11.1 This study presents no more than minimal risk as it only involves ultrasound 
which is non-invasive, will add less than 10 minutes to the total anesthetic 
time, and written consent is normally not required.  
12.0 Local Number of Subjects 
12.1 50 
13.0 Recruitment Methods 
13.1 Subjects will be recruited from the surgery unit pre-op area.  They will be 
identified by reviewing OR schedules in Epic. 
14.0 Withdrawal of Subjects* 
N/A 
 
15.0 Risks to Subjects* 
15.1 Although not likely, there may be a potential risk for breach of patient 
health information. There are no study related physical risks to study 
subjects associated with this study. All study related procedures are non-
invasive. 
15.2 Subject information will not be given to any other investigators. Subjects 
and their information will be closely monitored and guarded by study staff; 
there will be limited access to patients and their information by trained study 

PROTOCOL TITLE: Accuracy of manual palpation vs ultrasound for spinal anesthesia in 
children less than 1 year of age.  
 
 
Page 5 of 9 
HRP-503  v.12.10.18 
staff; and subject information will only be shared and discussed between 
study staff specific to this study. Subject PHI will be stored in a locked 
cabinet, and will be stored and maintained in password protected computer 
files. 
16.0 Potential Benefits to Subjects* 
16.1 No direct benefit to the subject. 
17.0 Data Management* and Confidentiality 
17.1  A 2 by 2 contingency table with a chi-squared analysis will be performed to 
compare the accuracy of surface palpation versus ultrasonography. Other 
data including time to perform ultrasonography and level at which the conus 
medullaris ends will be presented as secondary outcomes in tabular format 
for descriptive purposes without the need for statistical comparison or 
analysis. 
17.2 Research records will be stored in a locked cabinet and password 
protected computer.  Only certified research personnel will be given 
access to identifiable subject information. 
17.3 Once the data collection and analysis are complete and the study 
results have been published identifiers will be destroyed.  Six years 
after research is complete, per NCH guidelines as this meets both 
HIPAA and OHRP regulations, all electronic files will be 
permanently deleted. 
18.0 Provisions to Monitor the Data to Ensure the Safety of Subjects* 
18.1 The study will only be monitored by the study investigators. 
19.0 Provisions to Protect the Privacy Interests of Subjects 
19.1 Subject information will not be given to any other investigators. 
Subjects and their information will be closely monitored and guarded 
by study staff; there will be limited access to patients and their 
information by trained study staff; and subject information will only 
be shared and discussed between study staff specific to this study. 
Describe the steps that will be taken to protect subjects’ privacy 
interests. “Privacy interest” refers to a person’s desire to place limits 
on whom they interact or whom they provide personal information. 
20.0 Compensation for Research-Related Injury 
20.1 None 
21.0 Economic Burden to Subjects 
21.1 None 
22.0 Consent Process 

PROTOCOL TITLE: Accuracy of manual palpation vs ultrasound for spinal anesthesia in 
children less than 1 year of age.  
 
 
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HRP-503  v.12.10.18 
22.1 We are requesting a waiver of informed consent documentation.  
Subjects will receive a complete explanation of the study and will be 
asked to consent verbally. Subjects will receive a written summary 
of the research as outlined in the attached written Study Information 
Sheet.  Subjects will not be asked to sign a consent form.  
23.0 Process to Document Consent in Writing 
N/A 
24.0 Setting 
24.1 Subjects will be recruited from Surgery Unit and all study 
procedures will take place in the OR after the subject has been 
anesthetized.  
25.0 Resources Available 
25.1 The department of Anesthesiology and Pain Medicine has 2 research 
coordinators and 2 research associates that will be enrolling subjects 
for this study.  All study staff will be trained on the study 
procedures. 
26.0 Multi-Site Research* 
N/A 
 
27.0   Protected Health Information Recording 
 
1.0 
Indicate which subject identifiers will be recorded for this research. 
☒  Name 
☐  Complete Address 
☒  Telephone or Fax Number 
☐  Social Security Number (do not check if only used for ClinCard) 
☒  Dates (treatment dates, birth date, date of death) 
☐  Email address, IP address or url 
☒  Medical Record Number or other account number 
☐  Health Plan Beneficiary Identification Number 
☐  Full face photographic images and/or any comparable images (x-rays) 
☐  Account Numbers 
☐  Certificate/License Numbers 
☐  Vehicle Identifiers and Serial Numbers (e.g. VINs, License Plate Numbers) 
☐  Device Identifiers and Serial Numbers 
☐  Biometric identifiers, including finger and voice prints 
☐  Other number, characteristic or code that could be used to identify an 
individual 
☐  None (Complete De-identification Certification Form) 
 

PROTOCOL TITLE: Accuracy of manual palpation vs ultrasound for spinal anesthesia in 
children less than 1 year of age.  
 
 
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HRP-503  v.12.10.18 
2.0   
Check the appropriate category and attach the required form* on the Local 
Site Documents, #3. Other Documents, page of the application.  (Choose one.) 
☐  Patient Authorization will be obtained. (Include the appropriate HIPAA 
language (see Section 14 of consent template) in the consent form OR attach 
the HRP-900, HIPAA AUTHORIZATION form.) 
☒  Protocol meets the criteria for waiver of authorization. (Attach the HRP-901, 
WAIVER OF HIPAA AUTHORIZATION REQUEST form.) 
☐  Protocol is using de-identified information. (Attach the HRP-902, DE-
IDENTIFICATION CERTIFICATION form.) (Checked "None" in 1.0 above) 
☐  Protocol involves research on decedents. (Attach the HRP-903, RESEARCH 
ON DECEDENTS REQUEST form.) 
☐  Protocol is using a limited data set and data use agreement. (Contact the 
Office of Technology Commercialization to initiate a Limited Data Use 
Agreement. 
 
*Find the HIPAA forms in the IRB Website Library, Templates. 
 
Attach the appropriate HIPAA form on the “Local Site Documents, #3. 
Other Documents”, page of the application. 
 
3.0    How long will identifying information on each participant be maintained? 
Following publication of study results, research records will be stored for a period 
of 3-5 years and then will be destroyed by placing in a secure shredding bin. 
 
4.0 
Describe any plans to code identifiable information collected about each 
participant. None 
 
5.0 
Check each box that describes steps that will be taken to safeguard the 
confidentiality of information collected for this research: 
☒ Research records will be stored in a locked cabinet in a secure location 
☒ Research records will be stored in a password-protected computer file 
☐ The list linking the assigned code number to the individual subject will be 
maintained separately from the other research data 
☒ Only certified research personnel will be given access to identifiable 
subject information 
 
6.0 
Describe the provisions included in the protocol to protect the privacy 
interests of subjects, where "privacy interests" refer to the interest of 
individuals in being left alone, limiting access to them, and limiting access to 
their information. (This is not the same provision to maintain the 
confidentiality of data.) 
 
Subject information will not be given to any other investigators. Subjects and 
their information will be closely monitored and guarded by study staff; there will 
be limited access to patients and their information by trained study staff; and 
subject information will only be shared and discussed between study staff specific 

PROTOCOL TITLE: Accuracy of manual palpation vs ultrasound for spinal anesthesia in 
children less than 1 year of age.  
 
 
Page 8 of 9 
HRP-503  v.12.10.18 
to this study. Describe the steps that will be taken to protect subjects’ privacy 
interests. “Privacy interest” refers to a person’s desire to place limits on whom 
they interact or whom they provide personal information. 
 
Confidential Health Information 
 
1.0 
Please mark all categories that reflect the nature of health information to be 
accessed and used as part of this research. 
 
☒  Demographics (age, gender, educational level) 
☒  Diagnosis 
☐  Laboratory reports 
☐  Radiology reports 
☐  Discharge summaries 
☒  Procedures/Treatments received 
☒  Dates related to course of treatment (admission, surgery, discharge) 
☐  Billing information 
☐  Names of drugs and/or devices used as part of treatment 
☐  Location of treatment 
☐  Name of treatment provider 
☐  Surgical reports 
☒  Other information related to course of treatment 
☐  None 
 
2.0 
Please discuss why it is necessary to access and review the health information 
noted in your response above. 
It is necessary to meet the objectives of the study and to analyze the data. 
 
3.0 
Is the health information to be accessed and reviewed the minimal necessary to 
achieve the goals of this research?  ☒ Yes    ☐ No 
 
4.0 
Will it be necessary to record information of a sensitive nature?  ☐ Yes   ☒ No 
 
5.0 
Do you plan to obtain a federally-issued Certificate of Confidentiality as a means 
of protecting the confidentiality of the information collected?  ☐ Yes   ☒ No 
 
References 
1. Hayes J, Borges B, Armstrong D, et al. Accuracy of manual 
palpation vs ultrasound for identifying the L3-L4 intervertebral space level in 
children. Paediatr Anaesth 2014;24:510-15. 
2. Olowoyeye A, Fadahunsi O, Okudo J, et al. Ultrasound imaging versus palpation 
method for diagnostic lumbar puncture in neonates and infants: a systematic 
review and meta-analysis. BMJ Paediatrics Open 2019;3:e000412.  

PROTOCOL TITLE: Accuracy of manual palpation vs ultrasound for spinal anesthesia in 
children less than 1 year of age.  
 
 
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HRP-503  v.12.10.18 
3. Duniec L,  Nowakowski P,  Kosson D ,  Łazowski T. Anatomical landmarks 
based assessment of intravertebral space level for lumbar puncture is misleading 
in more than 30%. Anaesthesiol Intensive Ther 2013;45:1-6.  
4. Baxter B, Evans J, Morris R, et al. Arch Dis Child Fetal Neonatal Ed 
2016;101:F448-50.