Recruiting

Pupillometry Measurements

Sponsor:

NeurOptics Inc

Code:

NCT07573150

Conditions

Opioid-Induced Respiratory Depression

Postoperative Complications (Cardiopulmonary)

Respiratory Complications Due to Anesthesia

Eligibility Criteria

Sex: All

Age: 3 - 17

Healthy Volunteers: Accepted

Interventions

Infrared Pupillometry

Study Details

Brief 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.

Conditions

Opioid-Induced Respiratory Depression

Postoperative Complications (Cardiopulmonary)

Respiratory Complications Due to Anesthesia

Study ID

NCT07573150

Start date

May 4, 2026

Status verified date

Apr, 2026

Completion date

Apr 30, 2027

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 17

Healthy Volunteers: Accepted

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 pupillometry measurements (e.g., due to eye injury or inability to safely perform measurement)
  • Patients not receiving opioids as part of perioperative care
  • Any condition that, in the opinion of the investigator, would interfere with study participation or data interpretation

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

Pediatric Tonsillectomy Patients

Pediatric participants aged 3 to less than 18 years undergoing tonsillectomy. Participants will undergo non-invasive pupillometry measurements at predefined perioperative time points. Pupillometry data are collected for research purposes only and will not be used to guide clinical care. All participants will receive standard perioperative management as determined by the clinical team.

Interventions

Infrared 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.

Primary outcome measure

  • Occurrence of Postoperative Opioid-Induced Respiratory Depression [ Time Frame: From arrival in post-anesthesia care unit (PACU) through PACU discharge (up to 4 hours postoperatively) ]

Central Contacts and Locations

Central contacts

Alisha Maslanka, BS, CCRC

412-491-2748alisha.maslanka@chp.edu

Senthilkumar Sadhasivam, MD

513-253-4684sadhasivams@upmc.edu

Locations

UPMC Children's Hospital of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Alisha Maslanka, BS, CCRC

412-491-2748alisha.maslanka@chp.edu

Himali Vyas, M.B.B.S

734.203.9987vyash3@upmc.edu

Principal Investigator:

Mihaela Visoiu, MD

More Information

Sponsor

NeurOptics Inc

Last update posted

May 8, 2026

Last verified

Apr, 2026

Keywords

  • Sedation
  • Postoperative Period
  • Perioperative Monitoring
  • Pediatrics
  • Pupillary Light Reflex
  • Pupillometry
  • Analgesia
  • Anesthesia
  • Opioids
  • Hypoventilation
  • Oxygen Desaturation
  • Opioid-Induced Respiratory Depression
  • Respiratory Depression

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by NeurOptics Inc on 2026-05-08. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.