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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-12

Study Completion Date

2018-04-27

Brief Summary

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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.

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Detailed Description

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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.)

Conditions

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Blood Pressure

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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NIRS Monitoring

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

NIRS Monitoring

Intervention Type DEVICE

NIRS data will be collected throughout the surgery

Interventions

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NIRS Monitoring

NIRS data will be collected throughout the surgery

Intervention Type DEVICE

Eligibility Criteria

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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

Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No