Changes in Cerebral Oxygenation During Laparoscopic Pyloromyotomy

Study Overview
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Brief Summary
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A prospective study that will assess the effect of laparoscopy on tissue oxygenation in the patients undergoing a laparoscopic pyloromyotomy at Nationwide Children's Hospital. Tissue oxygenation will be assessed non-invasively using near infrared spectroscopy, a device that is commonly used in our operating rooms to assess cerebral and tissue oxygenation.

Detailed Description
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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, the investigators 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.

Official Title
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Changes in Cerebral Oxygenation During Laparoscopic Pyloromyotomy

Conditions
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Pyloric Stenosis

Intervention / Treatment
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* Device: Near infrared spectroscopy (NIRS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children at Nationwide Children's Hospital under the age of 18 years who are having laparoscopic pyloromyotomy Exclusion Criteria: None

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laparoscopic pyloromyotomy<br>Infants undergoing laparoscopic pyloromyotomy. | Device: Near infrared spectroscopy (NIRS)<br>* One monitor will be placed on the forehead to measure cerebral oxygenation and a second over the lower back to measure tissue (muscle or renal) oxygenation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebral Regional Oxygen Saturation (rSO2) | Near-infrared spectroscopy (NIRS model INVOS 5100; Covidien, Minneapolis, MN, USA) with sensors (Neonate SomaSensor® CNN; Covidien, Minneapolis, MN, USA) placed on the forehead. | At time of incision | 
| Cerebral Regional Oxygen Saturation (rSO2) | Near-infrared spectroscopy (NIRS model INVOS 5100; Covidien, Minneapolis, MN, USA) with sensors (Neonate SomaSensor® CNN; Covidien, Minneapolis, MN, USA) placed on the forehead. | At the end of laparoscopy | 
| Renal Regional Oxygen Saturation (rSO2) | Near-infrared spectroscopy (NIRS model INVOS 5100; Covidien, Minneapolis, MN, USA) with sensors (Neonate SomaSensor® CNN; Covidien, Minneapolis, MN, USA) placed on the left posterior-lateral flank. | At time of incision | 
| Renal Regional Oxygen Saturation (rSO2) | Near-infrared spectroscopy (NIRS model INVOS 5100; Covidien, Minneapolis, MN, USA) with sensors (Neonate SomaSensor® CNN; Covidien, Minneapolis, MN, USA) placed on the left posterior-lateral flank. | At the end of laparoscopy |