Clinical trial NCT03057587: The Newborn Project: Examining the Oxygenation of Brain Tissue During General Anesthesia
Official title: The Newborn Project: A Prospective Observational Study Examining the Oxygenation of Brain Tissue During General Anesthesia Using Near Infrared Spectroscopy Technology
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Blood Pressure
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2017-02-20
Enrollment: 0
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants scheduled to undergo general anesthesia at 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.)

Eligibility criteria: 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

Primary outcomes:
measure: Cerebral Oxygenation
timeFrame: Intraoperative period
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Mary Ellen McCann, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1097/ALN.0000000000001310.
citation: 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.
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. doi: 10.1186/s12871-016-0274-2.
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.