Pupillometry in Identifying Risk of Postoperative Opioid-induced Respiratory Depression in Children Undergoing Tonsillectomy
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.
연구 개요
상태
개입 / 치료
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Alisha Maslanka, BS, CCRC
- 전화번호: 412-491-2748
- 이메일: alisha.maslanka@chp.edu
연구 연락처 백업
- 이름: Senthilkumar Sadhasivam, MD
- 전화번호: 513-253-4684
- 이메일: sadhasivams@upmc.edu
연구 장소
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California
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San Francisco, California, 미국, 94158
- 아직 모집하지 않음
- UCSF Benioff Children's Hospital
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연락하다:
- Rachel Eshima McKay, MD
- 전화번호: 415-310-7722
- 이메일: Rachel.Eshima@ucsf.edu
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연락하다:
- Travis Rimando, BS
- 전화번호: 415-260-8568
- 이메일: Travis.Rimando@ucsf.edu
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Pennsylvania
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Pittsburgh, Pennsylvania, 미국, 15213
- 모병
- UPMC Children's Hospital of Pittsburgh
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연락하다:
- Alisha Maslanka, BS, CCRC
- 전화번호: 412-491-2748
- 이메일: alisha.maslanka@chp.edu
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연락하다:
- Himali Vyas, M.B.B.S
- 전화번호: 734.203.9987
- 이메일: vyash3@upmc.edu
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수석 연구원:
- Mihaela Visoiu, MD
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
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.
|
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.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Occurrence of Postoperative Opioid-Induced Respiratory Depression
기간: From arrival in post-anesthesia care unit (PACU) through PACU discharge (up to 4 hours postoperatively)
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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.
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From arrival in post-anesthesia care unit (PACU) through PACU discharge (up to 4 hours postoperatively)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Opioid Consumption
기간: 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.
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Total opioid dose administered during the intraoperative and immediate postoperative period, recorded from the medical record and normalized to body weight where appropriate.
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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.
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Sedation Level
기간: During PACU stay (up to 4 hours postoperatively)
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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.
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During PACU stay (up to 4 hours postoperatively)
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Pain Scores
기간: During PACU stay (up to 4 hours postoperatively)
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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.
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During PACU stay (up to 4 hours postoperatively)
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Postoperative Nausea and Vomiting
기간: During PACU stay (up to 4 hours postoperatively)
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Occurrence of nausea and/or vomiting documented in the medical record during the PACU stay.
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During PACU stay (up to 4 hours postoperatively)
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공동 작업자 및 조사자
스폰서
협력자
수사관
- 연구 책임자: Jeffrey W Oliver, PhD, NeurOptics Inc
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- NIH-OiRD
- R44DA055407 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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