Peri-operative NIRS Monitoring In Infants

The purpose of this research study is to examine the effects of routine anesthesia on infant brain oxygen levels. The investigators do not know how anesthesia effects blood flow in the brain of infants during surgery. This study will help the investigators detect possible blood flow changes in the brain for infants undergoing anesthesia. A monitor and sensors (NIRS or near-infrared spectroscopy) which use light to measure oxygen levels in the blood will be used. Sensors will rest on the child's skin and record measurements before, during and after the surgery.

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Key information

Conditions

Anesthesia

Age range

Up to 6 month

Sex eligibility

All sexes

Study type

Observational

Primary location

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

About this study

Pre-operatively medical history will be collected along with baseline physiological data (Blood pressure, heart rate, date of birth, date of surgery, weight, gestational age at birth, gender, medical conditions, and medications). Given the importance of reliable blood pressure measurement- during the study, strict guidelines regarding proper blood pressure cuff placement and choice of cuff size will be followed. An upper extremity and the cuff index lines will be used to make sure that the cuff is appropriately sized. NIRS sensors will be applied pre-operatively in the operating room prior to induction of anesthesia. All NIRS values will be collected as blind values so as to not influence anesthetic management or clinical decisions.

Intra-operatively the NIRS values will be blindly recorded, physiological data and details of the anesthesia (the conduct of all clinical monitoring, including blood pressure measurements and anesthesia will not be affected in any way by this study). No additional blood pressure or other measurements will be made.

One week later the hospital record (for those infants still hospitalized) will be reviewed for evidence of new changes in neurological status (specifically seizures or other generalized or focal neurological deficits noted by the clinical team in the record and physical exam). For infants discharged home prior to one week after surgery, a phone call will be made to inquire about the occurrence of any events that required medical attention or treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Less than 6 months
Scheduled for intubation/anesthesia for clinical purposes for a surgical procedure in the Children's Hospital of Philadelphia (CHOP) Main operating room that is expected to last longer than 30 minutes

Exclusion criteria

Children where application of the NIRS would be impractical: for example surgery on the head or neck.
Children scheduled for cardiac surgery
Children with known major cardiovascular shunting
Children with known or suspected neurological abnormalities

Treatment and study plan

Primary outcomes

The incidence and range of cerebral deoxygenation during anesthesia in infants

Time frame: Duration of surgery (Up to 6 hours)

This data will be obtained by using an FDA-approved NIRS monitor. This device measures regional tissue hemoglobin saturation using combinations of spatially resolved near-infrared spectroscopy and modified Beer-Lambert law approaches, along with measure changes in tissue hemoglobin concentrations; in combination, these measurements allow changes in oxy- and deoxyhemoglobin concentrations in the tissue to be calculated. Data will be recorded prior to induction of anesthesia and throughout the procedure until the infant begins to wake or 30 after arrival to the unit, whichever occurs first.

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Registry information

Official study title

Cerebral Near-infrared Spectroscopy Monitoring in Infants During the Peri-operative Period: a Prospective Observational Cohort Study

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: May 13, 2015
Registry last updated: May 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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