Changes in Cerebral Oxygenation During Laparoscopic Pyloromyotomy
Phase: NA
Conditions: Pyloric Stenosis
Sponsor: Nationwide Children's Hospital

 
 
 
 
Changes in Cerebral Oxygenation During Laparoscopic 
Pyloromyotomy 
 
NCT03650842 
 
IRB Approval Date:  4/11/2018 
 
 

Title: Changes in cerebral oxygenation during laparoscopic pyloromyotomy 
 
Investigators: 
1. Mineto Kamada 
2. Joseph D. Tobias 
3. Hina Walia 
 
Describe the background and rationale for this project. Reference to peer 
reviewed literature is desirable:  With the evolution of technology, many types of 
intra-abdominal surgery in infants and children are performed using laparoscopy.  
Despite the benefits of such techniques in regards to postoperative recovery and pain 
when compared to open laparotomy, the insufflation of the peritoneum with CO2 
increases in intra-abdominal pressure (IAP) which may impact cardiac output, organ 
perfusion, and tissue oxygenation. 
  
How will your study be funded: No funding is required for this study. 
 
Provide a potential start date for your study to be included in the IRB 
application: Start date: April 1, 2016 – End date: April 1, 2018 
 
Describe the significance of the proposed research: Although generally safe and 
effective, the increase in IAP during laparoscopy may increase systemic and pulmonary 
vascular resistance and decrease cardiac output. In addition to that, there are other 
factors which can effect on the organ oxygenation during pneumoperitoneum (e.g. 
hypercarbia, Trendelenburg position).  Although blood pressure is maintained, there 
may be decreases in cardiac output and hence organ oxygen delivery. The current 
study will assess the effect of laparoscopy on tissue oxygenation in the patient 
population.  Tissue oxygenation will be assessed non-invasively using near infrared 
spectroscopy (NIRS device: INVOS 5100B; Somanetics, Troy, MI, USA), a device that is 
commonly used in our operating rooms to assess cerebral and tissue oxygenation. 
 
State the primary and secondary objectives of the study:  
1. To evaluate changes in tissue and cerebral oxygenation during laparoscopic 
pyloromyotomy. 
  
If this research is hypothesis driven, succinctly state the hypothesis: 
Laparoscopy will decrease tissue and cerebral oxygenation. 
 
Outline the major steps and methodologies in the clinical protocol.   
This prospective study will include 50 patients under the age of 18 years who are 
having laparoscopic pyloromyotomy.  There will be no change in the anesthetic or 
perioperative care of these patients.  Tissue and cerebral oxygenation will be monitored 
using near infrared spectroscopy (NIRS).  Prior to anesthetic induction, the NIRS 
monitor will be placed on the forehead. The device is non-invasive like pulse oximetry 

using a non-painful adhesive sticker.  The device can be applied to different sites on the 
body to measure cerebral, tissue or even organ oxygenation.  For the purpose of the 
study, we will place one monitor on the forehead to measure tissue oxygenation and a 
second over the lower back to measure tissue (muscle or renal) oxygenation.  These 
devices are used routinely in the operating room and the cardiothoracic intensive care 
unit for cardiac patients. Although not used on every surgical procedure, NIRS 
monitoring can be used on all patients who are undergoing major surgical procedures. 
Tissue and cerebral oxygenation will be recorded continuously starting just prior to 
anesthetic induction until the completion of the procedure. 
  
Identify the variables to be measured and how they will be statistically 
evaluated: Changes in tissue/renal and cerebral oxygenation will be compared at 
various times throughout the procedure using analysis of variance.  The specific times 
will be baseline (prior to induction), after anesthetic induction and prior to insufflation, 
during insufflation, and after insufflation is completed. The data will be also downloaded 
from the device and analyzed using analytical tool provided by the company. 
Demographic information such as medical record number, date of service, date of birth, 
gender, birth weight and week, ASA, height, weight, BMI, and diagnosis will be 
recorded. We will also record preoperative lab values, anesthesia time, procedure time, 
pneumoperitoneum time, vital signs and ventilator settings during the surgery.  
 
References:  
1. Tobias JD.  Anaesthesia for minimally invasive surgery in children. Best Pract Res 
Clin Anaesthesiol. 2002;16:115-30. 
2. Sun JS, Elsey N, Tobias JD. Perioperative management of a patient with 
suspected cerebral vascular insufficiency: Utility of cerebral oxygenation 
monitoring using near infrared spectroscopy.  Pediatr Anesth Crit Care J 
2014;2:105-111. 
3. Tytgat SH, Stolwijk LJ, Keunen K, Milstein DM, Lemmers PM, van der Zee DC. 
Brain oxygenation during laparoscopic correction of hypertrophic pyloric stenosis. 
J Laparoendosc Adv Surg Tech A. 2015;25:352-7. 
4. Kim JW, Shin WJ, Park I, Chung IS, Gwak M, Hwang GS. Splanchnic oxygen 
saturation immediately after weaning from cardiopulmonary bypass can predict 
early postoperative outcomes in children undergoing congenital heart surgery. 
Pediatr Cardiol. 2014;35:587-95