The Newborn Project: Examining the Oxygenation of Brain Tissue During General Anesthesia

Boston Children's Hospital

Status: Withdrawn

Conditions: Blood Pressure

Treatments: Device: NIRS Monitoring

Study type: Observational

Funder types: Other

Identifiers

NCT03057587

IRB-P00021194

Details and patient eligibility

About

This study will be an observational, prospective trial that will measure the cerebral oxygenation of infants scheduled to undergo general anesthesia at Boston Children's Hospital.

Full description

Data will be collected from the Near Infrared Spectroscopy (NIRS) monitor and the patient's medical record. When the NIRS sensor is attached to the patient's forehead the oxygenation of brain tissue will be continuously monitored. All other information will be routinely recorded as standard clinical care and this information will be obtained from the patient's medical record. The NIRS monitor data will by time synched to the anesthesia record and downloaded to a secured password protected file.

In the post-operative period, patient data will be collected including: 1) any skin findings related to the placement of the NIRS or pulse oximetry probes 2) any unanticipated need for hemodynamic support, 3) laboratory values including hemoglobin levels, electrolytes, and blood gases, 4) new neurological findings (seizures etc.)

Sex: All

Ages: Under 6 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children less than 6 months of age
• Undergoing a scheduled or emergent procedure with anesthesia at Boston Children's Hospital

Exclusion criteria

• Placement of NIRS sensor that will interfere with surgery
• Child has an allergy to medical grade adhesives or pre-existing skin irritation at the sensor site
• Scheduled for a cardiac procedure
• Patient's care team or patient's family declines participation
• American Society of Anesthesiologists (ASA) criteria of IV or greater
• Infants who are being treated with sympathomimetic medications intraoperatively

Trial design

0 participants in 1 patient group

NIRS Monitoring

Description:

A NIRS sensor will be placed on the forehead of the patient upon entry to the operating room and will remain on, as tolerated, for the duration of surgery

Treatment:

Device: NIRS Monitoring