NIRS/EEG monitoring
DeviceThe study intervention will be monitoring NIRS and EEG for one hour before surgery, during surgery, and up to 8-24 hours after surgery.
NCT Number: NCT05673499
The goal of this observational study is to determine the incidence of perioperative cerebral desaturation in neonates undergoing surgery for congenital malformations. The main questions it aims to answer are:
1. The perioperative factors associated with occurrence of cerebral desaturation 2. The association between perioperative cerebral desaturation, perioperative/hospital outcomes, and physiological conditions.
Participants will undergo Near-infrared spectroscopy (NIRS) and electroencephalogram (EEG) monitoring for one hour before surgery, during surgery, and up to 24 hours after surgery.
Interested in participating?
Request InfoUp to 60 week
All sexes
Observational
Perth Children's Hospital, Nedlands, Australia
The NIRS EEG sensors will be placed about an hour before surgery. The recording will start once sensors are placed, continue throughout the duration of surgery, and end 8-24 hours after end of surgery. Sensors will be removed at the end of recording. No additional anesthesia and/or sedation will be required for the preoperative and postoperative recordings. The EEG and NIRS monitors will be blinded to clinical staff. EEG and NIRS monitoring will not prolong anesthesia or the duration of the surgical repair, and should not interfere with routine patient care. NIRS and EEG data will be downloaded from the monitors at the end of recording for analysis.
Medical record review will be conducted at 100 days postop or hospital discharge (whichever is sooner). The information below will be extracted:
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The study intervention will be monitoring NIRS and EEG for one hour before surgery, during surgery, and up to 8-24 hours after surgery.
Time frame: 24 hours
The incidence of cerebral desaturation in participants will be assessed by the Near-infrared Spectroscopy (NIRS) data recording of <70% and/or >10% decrease from baseline for > 3 minutes
Time frame: up to 24 hours
Determined by EEG amplitude ≤ 10mV for ≥ 2 secs
Time frame: up to 100 days
Medical record review
Contact information is provided by the study sponsor or research team.
Elizabeth Ramsay
CONTACT
Paula Hu, RN, MSPH
CONTACT
Children's Hospital of Philadelphia
Other
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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.
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