Changes in Cerebral Oxygenation During Laparoscopic Pyloromyotomy

Nationwide Children's Hospital

Status: Completed

Conditions: Pyloric Stenosis

Treatments: Device: Near infrared spectroscopy (NIRS)

Study type: Interventional

Funder types: Other

Identifiers

NCT03650842

IRB16-00199

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 25 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children at Nationwide Children's Hospital under the age of 18 years who are having laparoscopic pyloromyotomy

Exclusion criteria

• None

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Laparoscopic pyloromyotomy

Experimental group

Description:

Infants undergoing laparoscopic pyloromyotomy.

Treatment:

Device: Near infrared spectroscopy (NIRS)