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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Alisha Maslanka, BS, CCRC
- 電話番号：412-491-2748
- メール：alisha.maslanka@chp.edu
研究連絡先のバックアップ
- 名前：Senthilkumar Sadhasivam, MD
- 電話番号：513-253-4684
- メール：sadhasivams@upmc.edu
研究場所
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California
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San Francisco、California、アメリカ、94158
- まだ募集していません
- UCSF Benioff Children's Hospital
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コンタクト：
- Rachel Eshima McKay, MD
- 電話番号：415-310-7722
- メール：Rachel.Eshima@ucsf.edu
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コンタクト：
- Travis Rimando, BS
- 電話番号：415-260-8568
- メール：Travis.Rimando@ucsf.edu
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Pennsylvania
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Pittsburgh、Pennsylvania、アメリカ、15213
- 募集
- UPMC Children's Hospital of Pittsburgh
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コンタクト：
- Alisha Maslanka, BS, CCRC
- 電話番号：412-491-2748
- メール：alisha.maslanka@chp.edu
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コンタクト：
- Himali Vyas, M.B.B.S
- 電話番号：734.203.9987
- メール：vyash3@upmc.edu
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主任研究者：
- Mihaela Visoiu, MD
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-
参加基準
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Occurrence of Postoperative Opioid-Induced Respiratory Depression
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Opioid Consumption
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
スポンサー
協力者
捜査官
- スタディディレクター：Jeffrey W Oliver, PhD、NeurOptics Inc
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- NIH-OiRD
- R44DA055407 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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