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: 10586096
• 负责人: ROBERT A. PARKER
• 金额: $ 38.93万
• 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 2025-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10586096
• 关键词: Abdomen; Acute Respiratory Distress Syndrome; Address; Affect; American College of Physicians; Anesthesia procedures; Anesthetics; Area; Atelectasis; Attention; Automobile Driving; Bacteria; Blinded; Budgets; Cardiac; Cardiac Surgery procedures; Caring; Case Report Form; Cessation of life; Clinical; Clinical Research; Collaborations; Data; Data Analyses; Data Collection; Data Coordinating Center; Early Mobilizations; Endotoxins; Enrollment; Ensure; Event; Functional disorder; Goals; Good Clinical Practice; Grant; Health Care Costs; Hospitalization; Hotlines; Incentives; Incidence; Information Dissemination; Infrastructure; Intervention; Lead; 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; Pain; 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; clinical database; clinical practice; data management; data sharing; design; experience; group intervention; inpatient surgery; 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.

项目总结 术后肺部并发症(PPC)是指对呼吸道产生不利影响的情况 影响术后患者的临床病程。PPC是影响围手术期的主要实体 大量患者的发病率和死亡率，并对医疗费用产生了实质性的影响。全国 据估计，每年有1,062,000人死亡，46,200人死亡，住院天数增加480万天。 腹部外科是PPC绝对数最多的领域。尽管购买力平价具有重要意义 作为致命的心脏并发症，这一领域的研究受到的关注要少得多，而且得到了很好的证实。 遗憾的是，减少PPC的围手术期策略是有限的。最近，我们和其他团体已经 提示麻醉相关干预措施的关键作用，如呼吸策略和给药 和逆转神经肌肉阻滞剂在减少PPC方面的作用，这一发现与 肺保护性通气在成人呼吸窘迫综合征(ARDS)中的有益作用。外科手术 患者与ARDS患者有很大的不同，因为大多数患者在手术开始时没有或仅有有限的肺损伤。 然而，术中麻醉和腹部手术干预会导致肺切除，并可能 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 在早期，非常需要肺保护。然而，关于避免PPC的战略的数据非常缺乏， 导致目前预防PPC的麻醉实践不尽人意。根据我们之前的发现， 我们提出了一种以麻醉为中心的捆绑法，以优化围手术期肺复张和减少PPC。它 包括最佳机械通气，包括个性化呼气末正压(PEEP) 最大限度地提高呼吸系统的顺应性，最大限度地减少驾驶压力；个性化使用神经肌肉 阻滞剂及其逆转；术后肺扩张和早期活动。我们建议 进行前瞻性多中心随机对照实用型试验，与盲法评估进行比较 750例接受最佳个体化麻醉剂的腹部大手术患者的PPC- 由这些干预措施与常规护理组成的中心管理捆绑包。我们假设这是 以麻醉为中心的捆绑包，专注于围手术期的肺复张，将最大限度地减少多发和 协同因素导致围手术期肺功能障碍，降低PPC发生率。至 检验这一假设，我们将使用之前发布的5分量表来比较参与者的PPC严重性 根据干预组之间术后前7天最严重的PPC。作为 统计数据协调中心为研究我们将：确保严谨的研究设计；细致 与临床协调中心合作实施研究；并全面执行 数据分析。我们的广泛传播结果的计划将通过建立一个 新的，临床上可行的以麻醉为中心的策略，以减少开放腹部手术后的PPC。