Optimization of Surgical Treatment for Pediatric Obstructive Sleep Apnea

小儿阻塞性睡眠呼吸暂停手术治疗的优化

• 批准号: 10687010
• 负责人: Erin Marie Kirkham
• 金额: $ 19.26万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-01 至 2026-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10687010
• 关键词: Adenoidal structure; Adoption; Affect; Anatomy; Anesthetics; Behavior; Behavioral; Black race; Blinded; Cardiovascular system; Child; Childhood; Clinical; Clinical Investigator; Clinical Trials; Cognitive; Consensus; Data; Development; Dexmedetomidine; Diagnostic; Drug usage; Endoscopy; Equipment and supply inventories; Fiber Optics; Frequencies; Functional disorder; Funding; Goals; Guidelines; Individual; International; Intervention; Intravenous; Knowledge; Left; Legal patent; Measurement; Measures; Medicine; Mentored Patient-Oriented Research Career Development Award; Mentorship; Morbidity - disease rate; National Heart, Lung, and Blood Institute; Neurocognitive; Obesity; Obstruction; Obstructive Sleep Apnea; Operative Surgical Procedures; Otolaryngologist; Outcome; Outcome Measure; Oxygen; Patient Selection; Pattern; Pharmaceutical Preparations; Physiological; Polysomnography; Population; Positioning Attribute; Postoperative Period; Predictive Value; Predictive Value of Tests; Procedures; Propofol; Protocols documentation; Quality of life; Questionnaires; Randomized; Randomized, Controlled Trials; Recommendation; Recording of previous events; Regimen; Research; Research Personnel; Research Training; Residual state; Resources; Respondent; Risk; Risk Factors; Sampling; Sedation procedure; Series; Severities; Site; Sleep; Sleep Apnea Syndromes; Soft Palate; Specificity; Standardization; Surveys; Symptoms; Testing; Time; Tonsil; Training; Translating; Treatment outcome; Ventilatory Depression; aged; airway obstruction; behavior rating scale; cardiovascular health; career; design; experience; flexibility; health care service utilization; improved; improved outcome; malignant supraglottis tumor; neuromuscular; optical fiber; outcome prediction; primary endpoint; prospective; respiratory; secondary endpoint; sedative; skills; surgery outcome; tongue root; treatment as usual; trial comparing

PROJECT SUMMARY/ABSTRACT Obstructive sleep apnea (OSA) affects 1-4% of children, can lead to cognitive, behavioral, and cardiovascular morbidity, and is associated with a 226% increase in healthcare utilization. Guidelines recommend adenotonsillectomy (AT) as first-line treatment for pediatric OSA and nearly half a million are performed in U.S. children annually. However, AT is a one-size-fits-all procedure for a condition with pathophysiology that can differ dramatically between individuals based on differences in upper airway anatomy and dynamics. These differences likely account for the high rate of persistent post-AT OSA. Drug-induced sleep endoscopy (DISE) is a flexible fiber-optic assessment of the upper airway performed under sedation that has potential to direct individualized surgical treatment and improve outcomes in children with OSA. While early series have demonstrated good outcomes after DISE-assisted surgery, there is currently no well-controlled, prospective data to support the use of DISE in children. Prospective research on pediatric DISE has been fundamentally hindered by the lack of a standardized sedation protocol for the procedure. Choice of sedative may be important as anesthetic drugs impact upper airway patency to various degrees. Fundamental questions about how DISE findings should be interpreted and applied cannot be answered without first understanding which anesthetic facilitates the most useful assessment of upper airway obstruction. The goal of this project is to determine which anesthetic should be used for DISE. We will perform a randomized controlled trial comparing the two anesthetic drugs most commonly used to sedate children for the procedure: dexmedetomidine (DEX) and propofol. The central hypothesis of this proposal is that PROP exaggerates dynamic obstruction compared to DEX, and thus DISE under DEX provides a more useful and predictive measurement of upper airway obstruction during sleep. To test this, we will 1) compare mean DISE obstruction scores under sedation with PROP versus DEX and 2) test the predictive value of obstruction seen on DISE but left untreated by AT on post-AT outcomes (improvement in symptoms, behavior, quality-of-life, and polysomnography measures) and need for further treatment for persistent post-AT OSA. To accomplish these aims, Dr. Kirkham will receive mentorship, focused didactic coursework and training in pediatric sleep medicine and on the design and implementation of randomized controlled trials. Dr. Kirkham’s long-term goal is to become a leading independent clinical investigator and expert in the surgical treatment of pediatric OSA. An NHLBI K23 award will provide Dr. Kirkham with the protected time and needed training to achieve her career goals and improve outcomes for children with sleep apnea.

项目概要/摘要 阻塞性睡眠呼吸暂停 (OSA) 影响 1-4% 的儿童，可导致认知、行为和心血管疾病 发病率，并且与医疗保健利用率增加 226% 相关。指南推荐 腺样体扁桃体切除术 (AT) 作为儿科 OSA 的一线治疗方法，在美国已实施近 50 万人次。 儿童每年。然而，AT 是一种针对病理生理学病症的万能手术，可以 由于上呼吸道解剖结构和动力学的差异，个体之间存在显着差异。这些 差异可能是 AT 后持续性 OSA 发生率较高的原因。药物诱导睡眠内窥镜检查 (DISE) 是在镇静状态下对上呼吸道进行的灵活光纤评估，有可能指导 个体化手术治疗并改善 OSA 儿童的预后。虽然早期系列有 DISE 辅助手术后显示出良好的结果，但目前尚无良好控制的、前瞻性的 支持在儿童中使用 DISE 的数据。儿科 DISE 的前瞻性研究已从根本上 由于缺乏标准化的镇静方案而受到阻碍。镇静剂的选择可能是 重要的是麻醉药物会不同程度地影响上呼吸道的通畅。有关的基本问题 如果不首先了解哪些内容，就无法回答如何解释和应用 DISE 研究结果 麻醉有助于对上呼吸道阻塞进行最有用的评估。该项目的目标是 确定 DISE 应使用哪种麻醉剂。我们将进行一项随机对照试验来比较 手术中最常用于使儿童镇静的两种麻醉药物： 右美托咪定 (DEX) 和异丙酚。该提案的中心假设是 PROP 夸大了动态阻碍 与 DEX 相比，因此 DEX 下的 DISE 提供了更有用和更具预测性的上层测量 睡眠时气道阻塞。为了测试这一点，我们将 1) 比较镇静状态下的平均 DISE 阻塞评分 使用 PROP 与 DEX 进行比较，以及 2) 测试在 DISE 上发现但未经 AT 治疗的阻塞的预测价值 AT 后结果（症状、行为、生活质量和多导睡眠图测量的改善） 并需要进一步治疗持续性 AT 后 OSA。为了实现这些目标，柯卡姆博士将获得 儿科睡眠医学以及设计和治疗方面的指导、重点教学课程和培训 实施随机对照试验。 Kirkham 博士的长期目标是成为领先的 儿科 OSA 手术治疗的独立临床研究者和专家。 NHLBI K23 奖项 将为 Kirkham 博士提供受保护的时间和所需的培训，以实现她的职业目标并提高 患有睡眠呼吸暂停的儿童的结果。

项目成果

Preoperative Predictors of Severe Respiratory Events After Tonsillectomy: Consideration for Pediatric Intensive Care Admission.

扁桃体切除术后严重呼吸事件的术前预测因素：考虑儿科重症监护入院。

• DOI: 10.1002/ohn.238
• 发表时间: 2023
• 期刊: Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery
• 作者: Kirkham,ErinM;Puglia,MichaelP;Haydar,Bishr;Jewell,ElizabethS;Leis,AledaM;Peddireddy,Nithin;Chervin,RonaldD
• 通讯作者: Chervin,RonaldD

Adenotonsillectomy for Snoring and Mild Sleep Apnea in Children: A Randomized Clinical Trial.

腺样体扁桃体切除术治疗儿童打鼾和轻度睡眠呼吸暂停：一项随机临床试验。

• DOI: 10.1001/jama.2023.22114
• 发表时间: 2023
• 期刊: JAMA
• 作者: Redline,Susan;Cook,Kaitlyn;Chervin,RonaldD;Ishman,Stacey;Baldassari,CristinaM;Mitchell,RonB;Tapia,IgnacioE;Amin,Raouf;Hassan,Fauziya;Ibrahim,Sally;Ross,Kristie;Elden,LisaM;Kirkham,ErinM;Zopf,David;Shah,Jay;Otteson,Todd
• 通讯作者: Otteson,Todd