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



Status:Withdrawn
Conditions:High Blood Pressure (Hypertension)
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:11/16/2018
Start Date:May 12, 2017
End Date:April 27, 2018

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The Newborn Project: A Prospective Observational Study Examining the Oxygenation of Brain Tissue During General Anesthesia Using Near Infrared Spectroscopy Technology

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.

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.)

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
We found this trial at
1
site
300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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mi
from
Boston, MA
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