2/2: An Anesthesia-Centered Bundle to Reduce Postoperative Pulmonary Complications: The PRIME-AIR Study.

2/2：以麻醉为中心的捆绑方案，可减少术后肺部并发症：PRIME-AIR 研究。

• 批准号: 10402844
• 负责人: ROBERT A. PARKER
• 金额: $ 50.46万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-03-19 至 2024-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10402844
• 关键词: Abdomen; Acute Respiratory Distress Syndrome; Address; Affect; American College of Physicians; Anesthesia procedures; Anesthetics; Area; Atelectasis; Attention; Automobile Driving; Blinded; Budgets; Cardiac; Caring; Case Report Form; Cessation of life; Clinical; Clinical Research; Collaborations; Data; Data Analyses; Data Collection; Data Coordinating Center; Early Mobilizations; Enrollment; Ensure; Event; Functional disorder; Goals; Good Clinical Practice; Grant; Health Care Costs; Hospitalization; Hotlines; Incentives; Incidence; Induction of neuromuscular blockade; Information Dissemination; Infrastructure; Inpatients; Intervention; Lead; Logistics; Lung; Manuals; Manuscripts; Mechanical ventilation; Methodology; Monitor; Morbidity - disease rate; Muscle; Muscle relaxation phase; National Heart, Lung, and Blood Institute; Neuromuscular Blocking Agents; Operative Surgical Procedures; Outcome; Paralysed; Participant; Patients; Pattern; Perioperative; Positive-Pressure Respiration; Postoperative Period; Prevention; Procedures; Process; Protocols documentation; Publishing; Quality Control; Randomized; Randomized Controlled Trials; Recommendation; Reporting; Research; Research Design; Research Personnel; Resources; Respiratory Diaphragm; Respiratory System; Role; Security; Severities; Site; Solid; Spirometry; Stretching; Supine Position; Surgical complication; System; Testing; Time; Training; Trauma; Ventilator; Visit; adjudication; base; clinical database; clinical practice; data management; data sharing; design; experience; group intervention; lung injury; mortality; personalized management; pragmatic trial; pressure; prevent; prospective; recruit; standard of care; statistics; systemic inflammatory response; treatment as usual; ventilation

PROJECT SUMMARY Postoperative pulmonary complications (PPCs) are conditions affecting the respiratory tract that adversely influence the clinical course of patients after surgery. PPCs are a major perioperative entity influencing the morbidity and mortality of a large number of patients, and with substantial impact on health care costs. National estimates suggest 1,062,000 PPCs/year, with 46,200 deaths, and 4.8 million additional days of hospitalization. Abdominal surgery is the field with the largest absolute number of PPCs. Although PPCs are as significant and lethal as cardiac complications, research in this area has received much less attention, and well established perioperative strategies to minimize PPCs are regrettably limited. Recently, our and other groups have suggested a crucial role of anesthesia related interventions such as ventilatory strategies, and administration and reversal of neuromuscular blocking agents in reducing PPCs, findings that are consistent with the beneficial effects of lung protective ventilation during the adult respiratory distress syndrome (ARDS). Surgical patients differ substantially from ARDS patients as most have no or limited lung injury at the start of surgery. Yet, intraoperative anesthetic and abdominal surgery interventions result in lung derecruitment and can predispose to or produce direct and indirect lung injury. Thus, effective anesthetic strategies specifically aiming at early lung protection are greatly needed. Yet, there is substantial lack of data on strategies to avert PPCs, leading to the current unsatisfactory anesthetic practice on PPC prevention. Based on our previous findings, we propose an anesthesia-centered bundle to optimize perioperative lung recruitment and reduce PPCs. It consists of optimal mechanical ventilation comprising individualized positive end-expiratory pressure (PEEP) to maximize respiratory system compliance and minimize driving pressures; individualized use of neuromuscular blocking agents and their reversal; and postoperative lung expansion and early mobilization. We propose to conduct a prospective multicenter randomized controlled pragmatic trial with blinded assessor to compare PPCs in 750 patients undergoing major open abdominal surgery receiving an optimal individualized anesthetic- centered management bundle composed of those interventions versus usual care. We hypothesize that this anesthesia-centered bundle, focused on perioperative pulmonary recruitment, will minimize multiple and synergistic factors responsible for the perioperative pulmonary dysfunction and reduce the rate of PPCs. To test this hypothesis, we will compare the participant's PPC severity using a previously published 5-point scale based on the most serious PPC during the first seven days after surgery between intervention groups. As the statistical and data coordinating center for the study we will: ensure rigorous study design; meticulous implementation of the study in collaboration with the clinical coordinating center; and perform comprehensive data analysis. Our plan for widespread dissemination of results will change clinical practice by establishing a new, clinically feasible anesthesia-centered strategy to reduce PPCs after open abdominal surgery.

项目摘要 术后肺部并发症（PPC）是影响呼吸道的疾病， 影响患者术后的临床进程。PPC是一种主要的围手术期实体， 大量患者的发病率和死亡率，并对医疗保健费用产生重大影响。国家 据估计，每年有1，062，000例PPC，46，200例死亡，480万个额外住院日。 腹部手术是PPC绝对数量最多的领域。虽然PPC同样重要， 由于心脏并发症的致命性，这一领域的研究受到的关注要少得多， 令人遗憾的是，减少PPC的围手术期策略有限。最近，我们和其他团体 提出了麻醉相关干预措施的关键作用，如麻醉策略和给药 和逆转神经肌肉阻滞剂在减少PPC，研究结果是一致的， 肺保护性通气在成人呼吸窘迫综合征（ARDS）中的有益作用。手术 患者与ARDS患者有很大不同，因为大多数患者在手术开始时没有或只有有限的肺损伤。 然而，术中麻醉和腹部手术干预导致肺去复张， 易导致或产生直接或间接的肺损伤。因此，有效的麻醉策略专门针对 早期肺保护是非常必要的。然而，关于避免PPC的战略的数据严重缺乏， 导致目前对PPC预防的麻醉实践不能令人满意。基于我们之前的发现， 我们提出了一种以麻醉为中心的束，以优化围手术期肺复张并减少PPC。它 包括最佳机械通气，包括个体化呼气末正压（PEEP）， 最大限度地提高呼吸系统顺应性，最大限度地降低驱动压力; 阻断剂及其逆转;术后肺扩张和早期活动。我们建议 进行一项前瞻性多中心随机对照实用性试验，由盲态评估者进行比较 接受最佳个体化麻醉的750例接受腹部大手术的患者的PPC- 由这些干预措施与常规护理组成的集中管理包。我们假设这 以麻醉为中心的捆绑，专注于围手术期肺复张，将最大限度地减少多个和 协同因素负责围手术期肺功能障碍，并降低PPC的发生率。到 为了检验这一假设，我们将使用先前发表的5点量表比较参与者的PPC严重程度 基于干预组之间手术后前7天内最严重的PPC。为 统计和数据协调中心的研究，我们将：确保严格的研究设计;细致 与临床协调中心合作实施研究;并进行全面的 数据分析我们广泛传播结果的计划将通过建立一个 一种新的、临床上可行的以麻醉为中心的策略，以减少腹部开放手术后的PPC。