Peri-operative NIRS Monitoring In Infants

NCT02442141 | Completed

• 1 other identifier: 14-011407
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to examine the effects of routine anesthesia on infant brain oxygen levels. The investigators do not know how anesthesia effects blood flow in the brain of infants during surgery. This study will help the investigators detect possible blood flow changes in the brain for infants undergoing anesthesia. A monitor and sensors (NIRS or near-infrared spectroscopy) which use light to measure oxygen levels in the blood will be used. Sensors will rest on the child's skin and record measurements before, during and after the surgery.

Conditions

Anesthesia

Keywords

Near-Infrared Spectroscopy; Cerebral; Infants; Anesthesia; Neurodevelopmental

Outcome Measures

Primary Outcomes (1)

• The incidence and range of cerebral deoxygenation during anesthesia in infants

  This data will be obtained by using an FDA-approved NIRS monitor. This device measures regional tissue hemoglobin saturation using combinations of spatially resolved near-infrared spectroscopy and modified Beer-Lambert law approaches, along with measure changes in tissue hemoglobin concentrations; in combination, these measurements allow changes in oxy- and deoxyhemoglobin concentrations in the tissue to be calculated. Data will be recorded prior to induction of anesthesia and throughout the procedure until the infant begins to wake or 30 after arrival to the unit, whichever occurs first.

  Duration of surgery (Up to 6 hours)

Eligibility Criteria

• Age: Up to 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children will be identified from the operating room schedules or, for emergency cases the coordinating anesthetist will contact the study team.

You may qualify if:

• Less than 6 months
• Scheduled for intubation/anesthesia for clinical purposes for a surgical procedure in the Children's Hospital of Philadelphia (CHOP) Main operating room that is expected to last longer than 30 minutes

You may not qualify if:

• Children where application of the NIRS would be impractical: for example surgery on the head or neck.
• Children scheduled for cardiac surgery
• Children with known major cardiovascular shunting
• Children with known or suspected neurological abnormalities

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Study Officials

• Francis X McGowan, MD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2015
• First Posted: May 13, 2015
• Study Start: April 28, 2015
• Primary Completion: May 31, 2016
• Study Completion: September 27, 2016
• Last Updated: May 15, 2018

Record last verified: 2018-05

Locations

US (1)