Pupillometry in Identifying Postoperative Opioid-induced Respiratory Depression in Children Undergoing Tonsillectomy
NeurOptics Inc
Summary
This study will evaluate whether quantitative pupillometry measurements can be used to identify children at risk for postoperative opioid-induced respiratory depression (OIRD) following tonsillectomy. Opioid-induced respiratory depression is a serious and potentially life-threatening complication that can occur after surgery, and current monitoring approaches are limited in their ability to predict which patients are at highest risk. In this prospective observational cohort study, approximately 300 pediatric patients undergoing tonsillectomy will undergo non-invasive pupillometry measurements at defined perioperative time points, including preoperative, intraoperative, and postoperative periods. Pupillometry measurements will be collected using a commercially available, FDA-regulated infrared pupillometer. These measurements will include pupil size, constriction and dilation velocities, and latency in response to light stimulation. Pupillometry data will be collected for research purposes only and will not be used to guide clinical care or treatment decisions. Standard clinical care will not be altered as part of this study. Clinical outcomes, including the occurrence of postoperative opioid-induced respiratory depression, opioid use, sedation levels, pain scores, and other postoperative events, will be recorded from the medical record. The goal of this study is to evaluate the relationship between pupillary response patterns and the occurrence of postoperative respiratory depression, and to support the development of predictive models that may improve early identification of patients at risk for opioid-related adverse events.
Description
This is a prospective, observational cohort study designed to evaluate the relationship between perioperative pupillary responses and postoperative opioid-induced respiratory depression (OIRD) in pediatric patients undergoing tonsillectomy. Approximately 300 participants aged 3 to less than 18 years will be enrolled across participating clinical sites. Pupillometry measurements will be obtained using a portable, automated infrared pupillometer at predefined perioperative time points, including preoperative baseline, intraoperative periods, and postoperative recovery. Measurements will include…
Eligibility
- Age range
- 3–17 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Age 3 to less than 18 years * Scheduled to undergo tonsillectomy with or without adenoidectomy * Planned postoperative recovery in a monitored clinical setting (e.g., post-anesthesia care unit) * Ability to obtain informed consent from parent or legal guardian and assent from the participant when developmentally appropriate Exclusion Criteria: * Known neurologic or ophthalmologic conditions that may affect pupillary function * Use of medications known to significantly alter pupillary response outside of standard perioperative care * Inability to obtain adequate pupillo…
Interventions
- DeviceInfrared Pupillometry
Non-invasive pupillometry measurements will be performed using a commercially available, FDA-regulated infrared pupillometer. Measurements will be collected at predefined perioperative time points for research purposes only and will not be used to guide clinical care.
Locations (2)
- UCSF Benioff Children's HospitalSan Francisco, California
- UPMC Children's Hospital of PittsburghPittsburgh, Pennsylvania