A Randomized Controlled Trial for Optimal Feeding Tube Placement
Phase: NA
Conditions: Enteral Feeding Intolerance
Sponsor: The University of Texas Health Science Center at San Antonio

17-704H, Meyer, Form BC, 11-21-17, NS                             vSept3-2014                                                                                                                                                                                                                                                       1 
 
COVER PAGE FOR PROTOCOL AND STATISTICAL ANALYSIS PLAN 
 
 
 
 
 
 
 
 
 
 
 
Official Study Title: A Randomized Controlled Trial for Optimal Feeding Tube 
Placement 
 
NCT number: NCT 
 
IRB Approval Date: 11-21-17 
 
Unique Protocol ID: HSC20170704H 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

17-704H, Meyer, Form BC, 11-21-17, NS                             vSept3-2014                                                                                                                                                                                                                                                       2 
 
Protocol Form: A Randomized Controlled Trial for Optimal Feeding Tube Placement 
 
Item 1 UTHSCSA 
Tracking Number 
HSC20170704H 
 
Item 2 Abstract / Project Summary 
Provide a succinct and accurate description of the proposed research. State the 
purpose/aims. Describe concisely the research design and methods for achieving the 
stated goals. This section should be understandable to all members of the IRB, 
scientific and non-scientific.   
DO NOT EXCEED THE SPACE PROVIDED. 
Purpose/Objectives: Define the optimal method to place an enteral feeding tube. Our objective is to perform a randomized controlled trial of two 
different methods of tube placement with outcomes of cost, safety, radiation exposure, and the time. 
Research Design/Plan: A randomized controlled trial comparing current standard blind method to CORTRAK enteral access system (CEAS), an FDA 
approved electromagnetic device to place enteric tubes.  
Methods: Patient population would include patients in pediatric intensive care unit, pediatric cardiac unit, intermediate medical care unit and pediatric 
floor who receives postpyloric feeding tube placements. We are going to monitor total time and number attempts required for each successful 
placement, correlation of findings on x-ray versus CEAS, cost-effectiveness of this new equipment with standard blind method and decrease in radiation 
exposure with CEAS. 
Clinical Relevance: For insertion of post-pyloric tube, standard blind technique is the most commonly used method. We plan to compare this routine 
methods with another FDA approved method of feeding tube placement using electromagnetic guidance. Our goal will be to determine if the 
electromagnetic  method decreases the number of attempts, duration of time, and the number of x-rays needed to place a feeding tube. Recent 
retrospective adult and pediatric studies document promising results with minimal complications using this technique.  
 
Item 3 
Background 
 
Describe past experimental 
and/or clinical findings 
leading to the formulation 
of your study.   
For research involving 
unapproved drugs, describe 
animal and human studies.   
For research that involves 
approved drugs or devices, 
describe the FDA approved 
uses of this drug/device in 
relation to your protocol. 
Insert background:  
Children admitted to PICU are undernourished 40-60% of times due to poor feeding tolerance. Critical 
illness is a catabolic stress state and nutritional requirements are much higher. Primary methods of 
nutrition delivery are parenteral nutrition (PN) and enteral nutrition(EN). Enteral feeding is preferable 
whenever possible as it is more physiological and more cost-effective without the added risk of nosocomial 
infection inherent with parenteral nutrition (PN). Two major routes of enteral nutrition are gastric feeding 
and postpyloric feeding. Because postpyloric EN reduces gastric residue, it reduces the risk of pulmonary 
aspiration and aspiration pneumonia. Postpyloric feeding has been shown to be associated with 
significantly lesser risk of pneumonia and vomiting as well as increased in total percentage of nutrition 
delivered compared to gastric tube feeding in critically ill patients. From our review of last 6 months’ patient 
charts in last 6 months, there were 85 incidences of postpyloric feeding tube placement in 46 patients and 
total 194 x-rays were done to confirm placement, averaging 2.3 X-rays per placement attempt.  
Item 4 
Purpose and rationale 
Insert purpose, objectives 
and research 
questions/hypotheses here. 
 If you cut and paste from 
another document, make 
sure the excerpted material 
answers the question 
Purpose:  
 
We hypothesize that enteric feeding tube placement under electromagnetic guidance using CEAS (Cortrak 
Enteral Access System) is superior to current standard blind technique. We wish to expand on previous 
studies to conclusively define that CEAS decreases number of attempts, total time and radiation exposure 
required during an accurate postpyloric feeding tube placement. 
Rationale: 
Previous studies have conclusively shown that standard blind technique is associated with higher number 
of attempts, longer total time duration and more x-rays for confirmation as compared to CEAS. None of the 

17-704H, Meyer, Form BC, 11-21-17, NS                             vSept3-2014                                                                                                                                                                                                                                                       3 
 
previous studies have been randomized though. We are planning to carry out a randomized controlled trial 
to evaluate CEAS more reliably and nullify population bias if any.  
 
October et al, Pediatr Crit Care Med 2009 Vol. 10, No. 2: Successful placement of postpyloric enteral tubes using electromagnetic 
guidance in critically ill children. 
 
Brown et al, American Journal of Critical Care, May 2017, Volume 26, No. 3: Use of electromagnetic device to insert postpyloric feeding 
tubes in a pediatric intensive care unit  
 
Goggans et al, Nutrition in Clinical Practice Volume 32 Number 2 April 2017 233 – 237, Transpyloric Feeding Tube Placement Using 
Electromagnetic Placement Device in Children 
Item 5 
Study Population(s) Being Recruited 
 
In your recruitment plan, how many 
different populations of prospective 
subjects do you plan to target? 
Provide number: 100  
 
Identify the criteria for inclusion: 
 
Identify the criteria for exclusion: 
 
e.g., a population can be individuals 
with type 2 diabetes controlled with diet 
and/or a population of healthy controls.  
Or a population can be individuals 
attending an education program, etc. 
 
List each different population on a 
separate row and provide a short 
descriptive label:   
(e.g., normal-healthy, diabetics, 
parents, children, etc.) 
 
To add rows use copy & paste 
- 
Children admitted to 
pediatric Floor, IMC, PICU 
and pediatric cardiac ICU 
who need a postpyloric 
feeding tube 
- 
Patient admitted to pediatric floor, 
IMC, pediatric ICU or pediatric 
cardiac ICU requiring postpyloric 
feeding tube placement of size 8F or 
more and not meeting any of 
exclusion criteria 
 
- 
Open chest wall 
- 
Open abdominal wall 
 
 
 
Item 6 
Research Plan / Description of the Research Methods a.  Provide a comprehensive narrative describing the research methods.   
Provide the plan for data analysis (include as applicable the sample size calculation). 
uq 
Step-by-Step Methods: We intend to conduct a randomized controlled trial comparing current standard blind 
technique to CORTRAK enteral access system (CEAS), the electromagnetic device to place enteric tubes. Both 
techniques are FDA approved and being used across the country. University hospital has recently purchased the 
CEAS and we have already used it to placed feeding tube in children. CEAS uses same feeding tube that is 
currently being used at UHS,. The stylet used with CEAS has a small magnetic tip to generate a signal captured 
by the receiver placed on the patient’s lower chest.. Receiver is connected to a monitor which shows the path of 
feeding tube as it advances during insertion. Blind technique uses the same tube and  same stylet except the 

17-704H, Meyer, Form BC, 11-21-17, NS                             vSept3-2014                                                                                                                                                                                                                                                       4 
 
nurse places the tube by moving the patient around.  
When a patient in pediatrics needs a post pyloric feeding tube, we approach the parents to explain the need for 
adequate nutrition in safe manner. After the clinical discussion, the parents will be informed that we are 
comparing 2 different methods of placement to determine which one can be completed with less attempts and x-
rays to confirm placement. As previous studies have documented safety and efficacy of this technique we will be 
performing a prospective randomized trial. Patients will be randomized using sealed envelopes in a locked box, 
prepared by a person not part of this study. We are planning to form a team of total 11 nurses (covering both day 
and night shifts) to be the super users for feeding tube placement. Each member will be trained with the new 
equipment for a period of 1-2 weeks before getting involved in the study. The identity of the nurses inserting 
feeding tube will not be collected. Feeding tube placement will occur per randomization. Regardless of method 
used, per local clinical practice, a chest xray is obtained to verify placement. If the tube is not shown to be 
placed correctly (regardless of the placement method), the tube will be repositioned, and another xray is taken 
until confirmation is obtained that the tube is in proper place. Data collection sheet (attached with this form), 
monitoring total time and attempts required, will be completed for every participant. An enrollment log will match 
a unique identifier assigned to each participant with their demographic information. All data will be entered and 
maintained on UTHSCSA REDCap server the remaining information (e.g., enrollment log and data sheet) will be 
in locked cabinet. Each successful placement will be considered 1 event. After placement if the feeding tube 
comes out accidentally or the child pulls it out, child will go through the randomization process again for repeat 
placement and new event will be considered as a new subject. At the time of analysis, we will carry out separate 
analysis for all subjects with initial placement and repeat placement. We are also going to monitor correlation of 
findings on x-ray versus CEAS and how closely CEAS predicts correct location confirmed by an x-ray post-
placement. We will compare cost-effectiveness of this new equipment with standard blind method. We are going 
to analyze if using CEAS brings radiation exposure down significantly for enteric tube placement. If statistically 
significant, we will start a separate study to analyze if CEAS can be substitute for x-ray confirmation and if the 
current practice of x-ray confirmation can be discontinued. Device has the FDA clearance for feeding tube 
placement without an X-ray confirmation. Concurrently, we will gather clinical data on secondary outcomes that 
include intensive care unit stay, hospital stay, mechanical ventilation days, reason for admission and time to 
achieve full feeds, previous gastrointestinal (GI) procedures or surgeries. 
Data Analysis Plan:  We will make all attempts to standardize the patients within each group. Meaning, we 
recognize that a healthy child with no significant past medical history may not be comparable to a child with 
caustic ingestion or a child with history of esophageal stricture or previous esophageal surgeries or a child with 
severe scoliosis. Within each of the groups of standard blind technique and CORTRAK Enteral Access System 
(CEAS) patients, we will index the results to the Pediatric Risk of Mortality (PRISM) score. To determine the 
difference between the two methods we performed a power analysis on our hypothesis that CEAS method will 
decrease radiation exposure, time to placement, and cost compared to the blind technique. The standard (two-
sided) F-test of association between CEAS and blind technique placement will yield a power of 86% given 40 
subjects with a Type I error of 0.05. We made this power calculation using PASS 2008 (NCSS, LLC. Kaysville, 
Utah). For each of the populations we are interested we will enroll a minimum of 100 individuals.  At 30 patients, 
we will perform a mid-study analysis to decide how long the study needs to continue.  

17-704H, Meyer, Form BC, 11-21-17, NS                                    vSept3-2014                                                                                                                                                                                                                                        5 
 
 
Item 7 Risks Section: 
Complete the following table to describe the risks of all research procedures listed in Step 2, Institutional Form (items 28-34).  Do not list risks of Routine care 
procedures here.  
 ☐ N/A, Risks are described in the informed consent document – do not complete this table. 
Research procedures 
 
example: 
• 
History and physical 
• 
Questionnaire 
• 
Laboratory tests 
 
Add or delete rows as needed 
Risks 
 
List the reasonably expected risks 
under the following categories as appropriate: 
Placement of device over child’s chest 
and abdomen  
Serious and likely; 
o none 
Serious and less likely; 
o none 
Serious and rare; 
o none 
o Not serious and likely; 
none 
Not serious and less likely 
o none 
 
Insertion of a feeding tube (no 
difference between both procedures) 
Serious and likely; 
o none 
Serious and less likely; 
o none 
Serious and rare; 
o Perforation of bowel 
o misplacement into lungs leading to pneumonitis 
Not serious and likely; 
o Discomfort to the child 
Not serious and less likely 
o none 
Data collection 
Serious and likely; 
o none 
Serious and less likely; 
o none 
Serious and rare; 
o none 
Not serious and likely; 
o none 
Not serious and less likely 
o Confidentiality breach