Peri-operative NIRS Monitoring In Infants
| Status: | Completed |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 5/17/2018 |
| Start Date: | April 28, 2015 |
| End Date: | September 27, 2016 |
Cerebral Near-infrared Spectroscopy Monitoring in Infants During the Peri-operative Period: a Prospective Observational Cohort Study
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.
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.
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.
(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.
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
We found this trial at
1
site
South 34th Street
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
215-590-1000
Phone: 215-590-4520
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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