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

Withdrawn

• Conditions: Blood Pressure
• Interventions: Device: NIRS Monitoring

• Registration Number: NCT03057587
• Lead Sponsor: Boston Children's Hospital

Brief Summary

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.

Detailed 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.)

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-02-15
• Study First Submitted QC: 2017-02-15
• Study First Posted: 2017-02-20
• Study Start: 2017-05-12
• Primary Completion: 2018-04-27
• Study Completion: 2018-04-27
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-09
• Last Update Posted: 2018-11-14

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NIRS Monitoring	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

Primary Outcome Measures

Name	Time	Method
Cerebral Oxygenation	Intraoperative period	Determine what factors are correlated with changes in the cerebral oxygenation

Trial Locations

Locations (1)

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States