Ultrasonographic Evaluation of Gastric Volume and Contents Before Surgery in Children
Phase: NA
Conditions: Surgery
Sponsor: Alok Moharir

Preoperative gastric point-of-care ultrasound in non-elective surgical 
procedures in pediatric-aged patients 
 
NCT04127331 
 
 
October 15, 2020 

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HRP-503  v.12.10.18 
 
PROTOCOL TITLE: Ultrasonographic evaluation of gastric volume and 
contents before surgery in children  
 
PRINCIPAL INVESTIGATOR: 
Name: Alok Moharir, MD 
Department/Center: Anesthesiology & Pain Medicine 
Telephone Number: 614-722-4200 
Email Address: Alok.Moharir@nationwidechildrens.org 
VERSION NUMBER/DATE: Version 3- September 4, 2020 
 
REVISION HISTORY 
 
Revision 
# 
Version Date 
Summary of Changes 
Consent Change? 
1 
11/18/2019 
Addition of ultrasound scan of 
great vessels. 
Yes – information 
sheet updated. 
2 
9/4/2020 
Removal of initials of study 
investigators to perform scans as 
other investigators have been 
trained to complete scans. 
Alternative scan placement when 
preferred method not feasible. 
No. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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1.0 
Study Summary 
 
Study Title 
Ultrasonographic evaluation of gastric volume and contents 
before surgery in children 
Study Design 
Prospective, non-blinded observational study 
Primary Objective 
The primary objective of this study is to evaluate gastric 
volume and contents in patients who are scheduled for 
elective, urgent, and emergent surgery 
Secondary Objective(s) 
None 
Research Intervention(s)/ 
Investigational Agent(s)  
There will be no change in anesthetic management or use of 
investigational agents.    
IND/IDE #  
Not applicable 
Study Population 
Patients who are scheduled for elective, urgent or emergent 
surgery 
Sample Size 
300 (100 in each group) 
Study Duration for 
individual participants 
Less than 10 minutes 
Study Specific 
Abbreviations/ Definitions  
CSA=cross sectional area 
POCUS=Point-of-Care Ultrasound  
RSI=Rapid Sequence Induction 
RLD=right lateral decubitus 
 
2.0 
Objectives 
2.1 The primary objective of this study is to evaluate gastric volume and 
contents as well as gall bladder size in patients scheduled for routine, 
urgent, and emergency surgery. 
2.2 The hypothesis is that patients with stress, pain and opioid 
administration will have delayed gastric emptying and therefore a 
larger gastric fluid volume than those scheduled for elective surgery. 
The patients who have an appropriate NPO time will have a larger 
gallbladder size than the patients with shorter NPO time. 
 
3.0 
Background 
3.1 Point-of-Care Ultrasonography (POCUS) has been recognized as a 
powerful tool to evaluate critically ill patients. Using gastric 
ultrasonography, we can evaluate gastric volume and the types of 
contents as well as gall bladder size. The cross-sectional area of the 
gastric antrum is used to calculate the gastric volume. The full 
stomach state in pediatric patients scheduled for elective surgery is 
low at only 0-1%. However, it is unknown how lack of appropriate 
NPO time affects gastric volume and contents as well as gall bladder 
size. The gallbladder stores bile and starts to empty after the 
presence of fatty food in duodenum. Gallbladder emptying also 

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requires relaxation of the sphincter of Oddi, which may be disturbed 
by opioids. Therefore, it may be useful to evaluate patient NPO 
status.  The diameter of great vessels has been used to evaluate 
patient volume status in pediatric patients.  
3.2 Point-of-care gastric ultrasound had a sensitivity of 1.0 and a 
specificity of 0.975 to detect a “full stomach”. 1 Using point-of-care 
gastric ultrasound, a previous study reported that 0-1 % of the 
healthy pediatric patients scheduled for elective surgery were at risk 
of pulmonary aspiration 2 3 However, 35 % of the adult patients 
scheduled for unplanned surgery had a full stomach even after ≥ 6 
hours of NPO time 4 The normal gallbladder sizes in healthy children 
has been evaluated after fasting in previous report. 5 There is no 
article which reports the relationship between NPO state and 
gallbladder size. 
 
3.3 Rapid sequence induction (RSI) is widely used to avoid pulmonary 
aspiration during anesthetic induction. However, RSI is the risk 
factor for oxygen desaturation and other airway complications when 
compared to standard anesthetic induction techniques. The current 
study will help identify which trauma patients are truly at risk for 
aspiration and therefore require RSI. 
 
4.0 
Study Endpoints 
4.1 The primary study endpoint is the number (percentage) of patients in 
the urgent, emergent group with a full stomach state as assessed by 
gastric volume and contents despite an appropriate NPO time. 
4.2 The secondary endpoint will be to determine gall bladder size 
between fasted patients undergoing elective versus urgent/emergent 
surgery. The other endpoint will be to evaluate the preoperative 
volume status. 
 
5.0 
Study Intervention/Investigational Agent 
1.1 The only novel intervention is the use of ultrasound to evaluate 
gastric volume and contents, gall bladder size, and diameter of great 
vessels. Ultrasound is a non-invasive device, used commonly in the 
perioperative setting for placement of vascular access and regional 
anesthesia. There will be no change in anesthetic care for the study.  
There is no risk added by the study and the use of ultrasound.  
5.1 The only interventions being used that is not normally used in 
general clinical practice is ultrasonography. The technique is non-
invasive and poses no risk. Ultrasonography will be performed by an 

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anesthesiologist who has significant experience with Point-of-Care 
Ultrasound.  
 
6.0 
Procedures Involved* 
6.1 
This is a prospective observational study that will be conducted in 
300 patients, ranging in age from 2 to 18 years who are scheduled 
for routine, urgent or emergent surgeries. There will be no change in 
clinical practice regarding choice of anesthetic technique as a result 
of this research study. Before surgery in the pre-operating area, the 
ultrasonographer will evaluate the gallbladder size and volume. 
Procedure time will be recorded for the ultrasonography. 
Demographic data, including age, sex, height, weight, nil per os time, 
preoperative symptoms, administered opioids, and types of the 
surgery will be recorded.       
6.2  
Ultrasound protocol 
All ultrasound scans will be performed by study investigators by 
using Sonosite X-porte (Sonosite Inc. USA) machine and 3-8 MHz 
curved linear probe with abdominal setting. The investigators have 
enough experiences of POCUS.  
All patients will be lying supine, followed by RLD position. Patients 
were placed in the supine position, followed by the right-lateral 
decubitus (RLD) position. In cases where it is not feasible to place 
the patient in the right lateral decubitus position, the patient can be 
placed in a 45 degree head up position with a bump placed under the 
left hip. The gastric antrum is identified in a sagittal plane between 
the left lobe of the liver and the pancreas at the level of the 
descending aorta and supra mesenteric artery or inferior vena cava, 
as previously reported. 6 One video clip will be recorded for each 
patient in the supine and RLD positions. The qualitative 
measurements (empty versus nonempty) will be reported to the 
attending anesthesiologist. The quantitative measurements will be 
performed at later time. The quantitative exam is performed using 
the cross-sectional area of the gastric antrum. The CSA of the 
antrum will be measured with a free-tracing method to follow the 
outer margin of the antrum corresponding to the serosa. 7 The gastric 
volume will be calculated using the following formula. 8 
Gastric volume (ml.kg-1) = [－7.8+0.035×CSA (mm2) + 0.127×
age (months)]/body weight (kg).  
The qualitative measurements will be performed using 3-point 
grading scale. 9 

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Grade 0: no fluid visible in the antrum in either the supine or RLD 
position. 
Grade 1: antral fluid visualized only in the RLD position. 
Grade 2: antral fluid visualized in both the supine and RLD position. 
“Full stomach is defined by the visualization of solid contents or 
frost-grass pattern and/or by a calculated gastric fluid volume >1.5 
ml.kg-1. 
The gallbladder size and volume will be evaluated as previously 
reported. 5 
The gallbladder volume was calculated as following formula. 
Volume = 0.52×L (the greatest length) ×W (anterior posterior 
dimension) ×W (transverse width)  
B and C are assumed to be equal. 
 
The diameter of great vessels will be measured in supine position. 
Demographic data, including age, sex, height, weight, nil per os time, 
preoperative symptoms, administered opioids, and types of the 
surgery will be recorded. 
 
6.3 There are no foreseeable risks associated with the use of ultrasound.  
6.4  
Ultrasound data will be stored in the ultrasound machine. The research 
team will transmit the data to the password-secured server and store as 
MP4 file and JPEG file. The data will then be deleted from the 
ultrasound machine. 

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7.0 
Data and Specimen Banking* 
N/A 
8.0 
Sharing of Results with Subjects* 
8.1 Results will not be shared with subjects. 
9.0 
Study Timelines* 
An individual study subject’s participation in the study should last 
approximately 10 minutes total. 
All study subjects should be enrolled within 1 year of study start. 
The study should be completed within 18 months 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 main OR pre-
operative area the day of their surgery. 
10.2 Inclusion criteria: ASA 1-3 patients aged 2-18 years of scheduled for 
elective, urgent, or emergent surgery under general anesthesia. 
Exclusion criteria: History of upper gastro-intestinal surgery.   
10.3 We will include children, and will not include adults unable to 
consent, pregnant woman, and prisoners as they are not part of our 
usual patient population. 
11.0 Vulnerable Populations* 
11.1 This study presents no more than minimal risk as it only involves 
ultrasound which is non-invasive, and written consent is normally 
not required.  
12.0 Local Number of Subjects 
12.1 300 (100 in each group of routine, urgent, and emergent cases).  
13.0 Recruitment Methods 
13.1 Potential subjects will be recruited in surgical preoperative area on 
the day of the surgery. The research team will contact the 
guardian/parents and obtain verbal consent.  Verbal assent will also 
be obtained from age appropriate patients. 
13.2 The patients to be recruited are those who are scheduled for surgery 
under general anesthesia in NCH operating rooms. 
13.3 Using Epic, the research team will check the patients scheduled for 
unplanned surgery in the NCH operating rooms. 

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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 is no study related physical risk 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 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 The qualitative finding will be given to the attending 
anesthesiologists. This information may impact subsequent 
anesthetic induction. 
17.0 Data Management* and Confidentiality 
17.1 Summary statistics will be described by using means and standard 
deviation for parametric variables and median with interquartile 
ranges (IQRs) for nonparametric variables. The Kolmogorov-
Smirnov test will be used to assess the normality of data. Bivariate 
analysis for paired continuous variables will be conducted using 
the paired t test and Wilcoxon signed-rank test, and 
for independent continuous variables it is conducted using 
the independent samples t-test and Wilcoxon rank-sum 
test. Bivariate analysis for categorical variables will be 
conducted using the Chi-square test or Fisher’s exact test, where 
appropriate. P value less than 0.05 is considered to indicate statistical 
significance. Statistical analysis will be done using SAS 9.4 and 
G*Power version 3.1.9.2. 
Primary Outcome: The primary outcome is the proportion of full 
stomach state.   
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 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. 

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18.0 Provisions to Monitor the Data to Ensure the Safety of Subjects* 
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.  
20.0 Compensation for Research-Related Injury 
N/A 
21.0 Economic Burden to Subjects 
N/A 
22.0 Consent Process 
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 
The research team will identify the potential subjects in anesthesia 
office by Epic and recruit them in the preoperative area. Research 
procedures will be performed in the pre-operating room. 
25.0 Resources Available 
25.1 We will need approximately 20 minutes per patient to explain the 
research protocol, obtain consent, and enroll patients. The 
Department of Anesthesiology and Pain Medicine has 2 research 
coordinators/RNs and 2 research associates that will be enrolling 
subjects for this study.  All study staff will be trained on the study 
procedures. 
Before the study start, the study protocol, the research procedures, 
research member’s duties, and functions will be informed by e-mail. 
After the e-mail is sent, the research meeting will be held. 
 
26.0 Multi-Site Research* 

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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) 
 
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? 

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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. 
N/A 
 
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 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 

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☐  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. 
 
Demographics need to be recorded to describe patient characteristics. Diagnosis 
and procedures need to be assessed for inclusion criteria. Names of 
medications need to be recorded to clarify the standardized management. 
 
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 
 
 
 
 

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References:  
1. 
Kruisselbrink R, Gharapetian A, Chaparro LE, et al. Diagnostic Accuracy of 
Point-of-Care Gastric Ultrasound. Anesthesia & Analgesia 2019;128:89-95. 
2. 
Desgranges FP, Gagey Riegel AC, Aubergy C, de Queiroz Siqueira M, Chassard 
D, Bouvet L. Ultrasound assessment of gastric contents in children undergoing elective 
ear, nose and throat surgery: a prospective cohort study. Anaesthesia 2017;72:1351-6. 
3. 
Bouvet L, Bellier N, Gagey-Riegel AC, Desgranges FP, Chassard D, De Queiroz 
Siqueira M. Ultrasound assessment of the prevalence of increased gastric contents and 
volume in elective pediatric patients: A prospective cohort study. Paediatric anaesthesia 
2018;28:906-13. 
4. 
Dupont G, Gavory J, Lambert P, et al. Ultrasonographic gastric volume before 
unplanned surgery. Anaesthesia 2017;72:1112-6. 
5. 
Yoo JH, Kwak HJ, Lee MJ, Suh JS, Rhee CS. Sonographic measurements of 
normal gallbladder sizes in children. Journal of clinical ultrasound : JCU 2003;31:80-4. 
6. 
Engelhardt T. Rapid sequence induction has no use in pediatric anesthesia. 
Paediatric anaesthesia 2015;25:5-8. 
7. 
Kruisselbrink R, Arzola C, Endersby R, Tse C, Chan V, Perlas A. Intra- and 
interrater reliability of ultrasound assessment of gastric volume. Anesthesiology 
2014;121:46-51. 
8. 
Spencer AO, Walker AM, Yeung AK, et al. Ultrasound assessment of gastric 
volume in the fasted pediatric patient undergoing upper gastrointestinal endoscopy: 
development of a predictive model using endoscopically suctioned volumes. Paediatric 
anaesthesia 2015;25:301-8. 
9. 
Perlas A, Davis L, Khan M, Mitsakakis N, Chan VW. Gastric sonography in the 
fasted surgical patient: a prospective descriptive study. Anesth Analg 2011;113:93-7.