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

NCT03057587 | Withdrawn

• 1 other identifier: IRB-P00021194
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Pressure

Outcome Measures

Primary Outcomes (1)

• Cerebral Oxygenation

  Determine what factors are correlated with changes in the cerebral oxygenation

  Intraoperative period

Study Arms (1)

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

Device: NIRS Monitoring

Interventions

NIRS Monitoring DEVICE

NIRS data will be collected throughout the surgery

NIRS Monitoring

Eligibility Criteria

• Age: Up to 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Infants scheduled to undergo general anesthesia at Boston Children's Hospital

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (4)

• 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.

  PMID: 27606930 BACKGROUND

• 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.

  PMID: 27862979 BACKGROUND

• 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.

  PMID: 27793105 BACKGROUND

• 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.

  PMID: 25929346 BACKGROUND

Study Officials

• Mary Ellen McCann, MD, MPH

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MPH

Study Record Dates

• First Submitted: February 15, 2017
• First Posted: February 20, 2017
• Study Start: May 12, 2017
• Primary Completion: April 27, 2018
• Study Completion: April 27, 2018
• Last Updated: November 14, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)