Changes in Cerebral Oxygenation During Laparoscopic Pyloromyotomy

Not Applicable

Completed

• Conditions: Pyloric Stenosis
• Interventions: Device: Near infrared spectroscopy (NIRS)

• Registration Number: NCT03650842
• Lead Sponsor: Nationwide Children's Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2017-07-07
• Study First Submitted: 2018-08-27
• Study First Submitted QC: 2018-08-28
• Study First Posted: 2018-08-29
• Primary Completion: 2018-10-08
• Study Completion: 2018-10-08
• Status Verified: 2019-11
• Results First Submitted: 2019-11-19
• Results First Submitted QC: 2019-11-19
• Last Update Submitted: 2019-11-19
• Results First Posted: 2019-12-06
• Last Update Posted: 2019-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Laparoscopic pyloromyotomy	Near infrared spectroscopy (NIRS)	Infants undergoing laparoscopic pyloromyotomy.

Primary Outcome Measures

Name	Time	Method
Renal Regional Oxygen Saturation (rSO2)	At the end of laparoscopy	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.
Cerebral Regional Oxygen Saturation (rSO2)	At the end of laparoscopy	Near-infrared spectroscopy (NIRS model INVOS 5100; Covidien, Minneapolis, MN, USA) with sensors (Neonate SomaSensor® CNN; Covidien, Minneapolis, MN, USA) placed on the forehead.

Trial Locations

Locations (1)

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States