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: 10478086
• 负责人: Erin Marie Kirkham
• 金额: $ 19.44万
• 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/10478086
• 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; Lead; Left; 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; 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; base; behavior rating scale; cardiovascular health; career; design; experience; flexibility; health care service utilization; improved outcome; malignant supraglottis tumor; neuromuscular; 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.

项目总结/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，并与医疗保健利用率增加226%相关。指南建议 腺样体扁桃体切除术（AT）作为儿童OSA的一线治疗，在美国有近50万例。 孩子们每年然而，AT是一种适用于病理生理学条件的通用程序， 基于上气道解剖结构和动力学的差异，个体之间的差异显著。这些 这些差异可能解释了AT后持续性OSA的高发生率。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的光纤评估， 个体化手术治疗和改善OSA儿童的预后。虽然早期的系列 在DISE辅助手术后显示出良好的结局，目前还没有良好的对照，前瞻性 支持儿童使用DISE的数据。儿童DISE的前瞻性研究从根本上 由于缺乏标准化的镇静程序而受到阻碍。镇静剂的选择可能是 重要的是麻醉药物在不同程度上影响上呼吸道开放。基本问题 如何DISE调查结果应该解释和应用不能回答没有第一次理解， 麻醉剂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。我们将进行随机对照试验， 两种最常用于在手术中镇静儿童的麻醉药：右美托咪定（DEX） 和异丙酚。该建议的中心假设是PROP夸大了动态阻塞 与DEX相比，因此DEX下的DISE提供了更有用和预测性的上 睡眠中的呼吸道阻塞为了验证这一点，我们将1）比较镇静下的平均DISE阻塞评分 用PROP与DEX比较，2）测试DISE上观察到但AT未治疗的梗阻的预测值 AT后结局（症状、行为、生活质量和多导睡眠图测量的改善） 并且需要进一步治疗持续性AT后OSA。为了实现这些目标，Kirkham博士将获得 指导，重点教学课程和培训，在儿科睡眠医学和设计， 实施随机对照试验。Kirkham博士的长期目标是成为 独立临床研究者和儿童OSA手术治疗专家。NHLBI K23奖 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 儿童睡眠呼吸暂停综合征的治疗