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

Blood Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03057587
• Other study ID #: IRB-P00021194
• Status: Withdrawn
• Start date: May 12, 2017
• Est. completion date: April 27, 2018

Study information

• Verified date: November 2018
• Source: Boston Children’s Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.)

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 27, 2018
• Est. primary completion date: April 27, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Months

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure

Intervention

Device:
• NIRS Monitoring
NIRS data will be collected throughout the surgery

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children’s Hospital

Country where clinical trial is conducted

United States, 

References & Publications (4)

Aly SA, Zurakowski D, Glass P, Skurow-Todd K, Jonas RA, Donofrio MT. Cerebral tissue oxygenation index and lactate at 24 hours postoperative predict survival and neurodevelopmental outcome after neonatal cardiac surgery. Congenit Heart Dis. 2017 Mar;12(2):188-195. doi: 10.1111/chd.12426. Epub 2016 Nov 10. — View Citation

de Graaff JC, Pasma W, van Buuren S, Duijghuisen JJ, Nafiu OO, Kheterpal S, van Klei WA. Reference Values for Noninvasive Blood Pressure in Children during Anesthesia: A Multicentered Retrospective Observational Cohort Study. Anesthesiology. 2016 Nov;125(5):904-913. — View Citation

Michelet D, Arslan O, Hilly J, Mangalsuren N, Brasher C, Grace R, Bonnard A, Malbezin S, Nivoche Y, Dahmani S. Intraoperative changes in blood pressure associated with cerebral desaturation in infants. Paediatr Anaesth. 2015 Jul;25(7):681-8. doi: 10.1111/pan.12671. Epub 2015 Apr 30. — View Citation

Razlevice I, Rugyte DC, Strumylaite L, Macas A. Assessment of risk factors for cerebral oxygen desaturation during neonatal and infant general anesthesia: an observational, prospective study. BMC Anesthesiol. 2016 Oct 28;16(1):107. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cerebral Oxygenation	Determine what factors are correlated with changes in the cerebral oxygenation	Intraoperative period