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.

项目摘要/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，并与226%的医疗保健利用率增加有关。指南建议 腺体扁桃体切除术(AT)作为治疗儿童阻塞性睡眠呼吸暂停综合征的一线治疗，在美国有近50万人接受手术。 每年都有孩子。然而，对于具有病理生理学的情况，AT是一种一刀切的手术方式，可以 由于上呼吸道解剖和动力学的不同，个体之间的差异很大。这些 差异可能是AT后持续OSA发生率高的原因。药物诱导睡眠内窥镜检查(DISE) 是一种在镇静状态下对上呼吸道进行的灵活的光纤评估，有可能引导 儿童阻塞性睡眠呼吸暂停的个体化手术治疗和改善预后。而早期的系列剧 DISE辅助手术后显示良好的结果，目前还没有得到很好控制的、前瞻性的 支持在儿童中使用DISE的数据。儿科DISE的前瞻性研究已经从根本上 由于缺乏标准化的镇静方案而受阻。镇静剂的选择可能是 麻醉药物对上呼吸道通畅有不同程度的影响。关于以下方面的基本问题 DISE的调查结果应该如何解释和应用，如果不首先了解 麻醉剂有助于对上呼吸道阻塞进行最有用的评估。这个项目的目标是 确定DISE应使用哪种麻醉剂。我们将进行一项随机对照试验，比较 两种最常用的麻醉药：右美托咪定(DEX)，用于给儿童进行手术镇静 还有异丙酚。这一提议的中心假设是，道具夸大了动态障碍 与DEX相比，DEX下的DISE提供了更有用和更具预测性的上 睡眠时呼吸道阻塞。为了测试这一点，我们将1)比较镇静状态下的平均Dise梗阻评分 使用PROP与DEX和2)测试在DISE上可见但未经AT处理的梗阻的预测价值 AT治疗后的结果(症状、行为、生活质量和多导睡眠图测量的改善) 并需要对持续的AT后OSA进行进一步治疗。为了实现这些目标，柯克汉姆博士将获得 指导，专注于儿科睡眠医学的教学课程和培训，以及设计和 实施随机对照试验。柯克汉姆博士的长期目标是成为领先的 独立的临床研究员和儿童阻塞性睡眠呼吸暂停的外科治疗专家。NHLBI K23奖 将为柯克汉姆博士提供有保障的时间和必要的培训，以实现她的职业目标并提高 睡眠呼吸暂停儿童的预后。

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