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: 10301406
• 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/10301406
• 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.

项目摘要/摘要 阻塞性睡眠呼吸暂停（OSA）影响1-4％的儿童，可能导致认知，行为和心血管 发病率，与医疗保健利用率增加226％有关。指南建议 在美国进行腺旋硅切除术（AT）作为小儿OSA的一线治疗和将近一百万个 每年的孩子。但是，AT是患有病理生理疾病的一定程度的所有程序 基于上呼吸道解剖结构和动力学的差异，个体之间的不同之处。这些 差异可能解释了OSA持续持续的高率。药物诱导的睡眠内窥镜检查（DISE） 是对在镇静下进行的上呼吸道的灵活的光纤评估，有可能导演 OSA儿童的个性化手术治疗并改善了预后。而早期系列有 表现出良好的结果后，在厌恶辅助手术后，目前尚无良好的控制，潜在的 数据支持在儿童中使用疾病。关于小儿疾病的前瞻性研究从根本上是 由于缺乏该过程的标准化镇静协议的阻碍。镇静剂的选择可能是 重要的是，由于麻醉药物会影响上呼吸道通畅的各种程度。基本问题 如果没有先了解哪个 麻醉促进了上呼吸道目标最有用的评估。这个项目的目标是 确定应使用哪种麻醉剂进行疾病。我们将进行比较的随机对照试验 两种麻醉药物最常用用于使儿童进行该手术镇静的药物：右美托胺（DEX） 和建议。该提议的中心假设是托管夸大了动态阻塞 与DEX相比，因此DEX下的DEX提供了更有用的和预测性的测量 睡眠期间的气道异议。为了测试这一点，我们将1）比较镇静下的平均反对反对分数 用道具与dex和2）测试反对在dise上看到的预测价值，但未经AT处理 关于后结果的结果（症状，行为，生活质量和多摄影术措施的改善） 并需要进一步治疗OSA的持续性。为了实现这些目标，柯克汉姆博士将收到 属性，专注的教学课程以及小儿睡眠医学以及设计和设计培训 实施随机对照试验。柯克汉姆博士的长期目标是成为领导者 独立的临床研究者和小儿OSA手术治疗的专家。 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改善 睡眠呼吸暂停儿童的结果。