Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Pupillometry in Identifying Risk of Postoperative Opioid-induced Respiratory Depression in Children Undergoing Tonsillectomy

6. mai 2026 oppdatert av: NeurOptics Inc

Pupillometry in Identifying Postoperative Opioid-induced Respiratory Depression in Children Undergoing Tonsillectomy

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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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 resting pupil diameter, pupillary light reflex parameters (including percent constriction, constriction velocity, dilation velocity, and latency), and pupillary unrest in ambient light.

Pupillometry measurements will be collected solely for research purposes and will not be used to guide clinical management. All patients will receive standard perioperative care as determined by the clinical team.

The primary outcome is the occurrence of postoperative opioid-induced respiratory depression, defined as persistent oxygen desaturation (SpO2 <90%) or respiratory rate <8 breaths per minute in the absence of airway obstruction in the post-anesthesia care unit. Secondary outcomes include opioid consumption, sedation scores, pain scores, and postoperative complications such as nausea and vomiting.

Data will be analyzed to assess the association between pupillary response parameters and the occurrence of respiratory depression, and to support development of predictive models for identifying patients at increased risk of opioid-related adverse events.

Studietype

Observasjonsmessig

Registrering (Antatt)

300

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Forente stater
    • California
      • San Francisco, California, Forente stater, 94158
        • Har ikke rekruttert ennå
        • UCSF Benioff Children's Hospital
        • Ta kontakt med:
        • Ta kontakt med:
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forente stater, 15213
        • Rekruttering
        • UPMC Children's Hospital of Pittsburgh
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Mihaela Visoiu, MD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn

Tar imot friske frivillige

Ja

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

The study population will consist of pediatric patients aged 3 to less than 18 years undergoing tonsillectomy with or without adenoidectomy at participating clinical sites. Participants will be enrolled from routine clinical care settings and will receive standard perioperative management. The study will include patients across a range of clinical characteristics representative of the typical pediatric tonsillectomy population.

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
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.
Enhet: 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.
Andre navn:
  • Quantitative Pupillometry

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Occurrence of Postoperative Opioid-Induced Respiratory Depression
Tidsramme: From arrival in post-anesthesia care unit (PACU) through PACU discharge (up to 4 hours postoperatively)
Postoperative opioid-induced respiratory depression is defined as the occurrence of either (1) oxygen saturation (SpO2) <90% for a sustained period, or (2) respiratory rate <8 breaths per minute, in the absence of airway obstruction, during the post-anesthesia care unit stay. Events will be identified from clinical monitoring data and medical record documentation.
From arrival in post-anesthesia care unit (PACU) through PACU discharge (up to 4 hours postoperatively)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Opioid Consumption
Tidsramme: From induction of anesthesia through transfer to the post-anesthesia care unit (PACU) (up to 2 hours) through PACU discharge (up to 4 hours postoperatively); data collection across these periods may extend up to 6 hours in total.
Total opioid dose administered during the intraoperative and immediate postoperative period, recorded from the medical record and normalized to body weight where appropriate.
From induction of anesthesia through transfer to the post-anesthesia care unit (PACU) (up to 2 hours) through PACU discharge (up to 4 hours postoperatively); data collection across these periods may extend up to 6 hours in total.
Sedation Level
Tidsramme: During PACU stay (up to 4 hours postoperatively)
Sedation level assessed using clinically documented sedation scales recorded during routine care in the post-anesthesia care unit (PACU), including scales such as the Richmond Agitation-Sedation Scale (RASS; range -5 to +4, where more negative values indicate deeper sedation) or equivalent institution-specific scales. Higher levels of sedation correspond to lower (more negative) scores.
During PACU stay (up to 4 hours postoperatively)
Pain Scores
Tidsramme: During PACU stay (up to 4 hours postoperatively)
Pain intensity scores measured using age-appropriate validated scales (e.g., Numeric Rating Scale or FLACC) as recorded during routine clinical care. The Numeric Rating Scale (0 to 10, where 0 indicates no pain and 10 indicates worst possible pain) and for the Face, Legs, Activity, Cry, Consolability (FLACC) scale (0 to 10, where higher scores indicate greater pain), as recorded during routine clinical care in the post-anesthesia care unit (PACU). Scale selection will be based on patient age and clinical appropriateness.
During PACU stay (up to 4 hours postoperatively)
Postoperative Nausea and Vomiting
Tidsramme: During PACU stay (up to 4 hours postoperatively)
Occurrence of nausea and/or vomiting documented in the medical record during the PACU stay.
During PACU stay (up to 4 hours postoperatively)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

NeurOptics Inc

Samarbeidspartnere

National Institute on Drug Abuse (NIDA)
University of California, San Francisco
University of Pittsburgh Medical Center

Etterforskere

  • Studieleder: Jeffrey W Oliver, PhD, NeurOptics Inc

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

4. mai 2026

Primær fullføring (Antatt)

30. april 2027

Studiet fullført (Antatt)

30. april 2027

Datoer for studieregistrering

Først innsendt

28. april 2026

Først innsendt som oppfylte QC-kriteriene

4. mai 2026

Først lagt ut (Faktiske)

7. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

8. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. mai 2026

Sist bekreftet

1. april 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • NIH-OiRD
  • R44DA055407 (U.S. NIH-stipend/kontrakt)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

IPD-planbeskrivelse

The study team has not yet determined whether individual participant data will be shared. Any future data sharing will be evaluated following study completion and will consider participant privacy, institutional policies, intellectual property considerations, and applicable NIH and regulatory requirements.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

produkt produsert i og eksportert fra USA

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere