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 术后肺并发症（PPC）是影响呼吸道的疾病 影响手术后患者的临床过程。 PPC是影响影响的主要围手术期实体 大量患者的发病率和死亡率，对医疗保健费用产生重大影响。国家的 估计表明每年为1,062,000 ppcs，死亡46,200人，住院时间为480万天。 腹部手术是PPC绝对数量最多的领域。尽管PPC同样重要，并且 致命为心脏并发症，该领域的研究受到了较少的关注，并且建立了良好 遗憾的是，围手术期策略是最小化PPC的策略。最近，我们和其他团体有 建议与麻醉相关的干预措施（例如通气策略和给药）起着至关重要的作用 在减少PPC中的神经肌肉阻断剂的逆转，与 成人呼吸窘迫综合征（ARDS）期间肺部保护性通气的有益作用。外科 患者与ARDS患者的差异很大，因为大多数在手术开始时没有或有限的肺损伤。 然而，术中麻醉和腹部手术干预措施会导致肺部降解，并且可以 易于直接和间接肺损伤。因此，有效针对的有效麻醉策略 在早期的肺部保护中非常需要。然而，关于避免PPC的策略的数据大幅度缺乏数据， 导致当前对PPC预防的麻醉习惯不令人满意。根据我们以前的发现 我们提出了一个以麻醉为中心的束，以优化围手术期的肺部募集并减少PPC。它 由最佳的机械通气组成，该通气包括个性化的阳性验证压力（PEEP） 最大化呼吸系统遵从性并最大程度地减少驾驶压力；神经肌肉的个性化使用 阻止特工及其逆转；以及术后肺部扩张和早期动员。我们建议 与盲评估者进行前瞻性多中心随机对照实用试验，以比较 750例接受大型腹部手术的患者的PPC接受了最佳的个性化麻醉 - 由这些干预措施与通常的护理组成的集中管理捆绑包。我们假设这是 以麻醉为中心的捆绑包，专注于围手术期肺募集，将使多个和 负责围手术期肺功能障碍并降低PPC的协同因素。到 检验此假设，我们将使用先前发布的5分制比较参与者的PPC严重性 基于干预组手术后的前7天，最严重的PPC。作为 统计和数据协调中心，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该研究；并执行全面 数据分析。我们广泛传播结果的计划将通过建立一个 开放腹部手术后，新的，临床上可行的以麻醉为中心的策略。