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。

基本信息

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
项目类别：
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

项目摘要

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.

项目概要术后肺部并发症 (PPC) 是影响呼吸道的病症，会对患者产生不利影响。影响手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，并对医疗保健费用产生重大影响。国家的据估计，每年发生 1,062,000 起 PPC，导致 46,200 人死亡，住院时间增加 480 万天。腹部外科是 PPC 绝对数量最多的领域。尽管 PPC 的重要性和与心脏并发症一样致命，这一领域的研究受到的关注要少得多，而且已经很成熟遗憾的是，减少 PPC 的围手术期策略有限。最近，我们和其他小组表明麻醉相关干预措施（例如通气策略和管理）发挥着至关重要的作用和逆转神经肌肉阻滞剂减少 PPC 的作用，这些发现与成人呼吸窘迫综合征（ARDS）期间肺保护性通气的有益作用。外科患者与 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复张，并可能诱发或产生直接和间接肺损伤。因此，有效的麻醉策略专门针对在早期，非常需要肺部保护。然而，关于避免 PPC 的策略的数据严重缺乏，导致目前 PPC 预防的麻醉实践不尽如人意。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方案，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的顺应性并最大限度地降低驾驶压力；个体化使用神经肌肉阻断剂及其逆转；以及术后肺扩张和早期活动。我们建议与盲法评估员进行前瞻性多中心随机对照实用试验进行比较 750 名接受大型开腹手术并接受最佳个体化麻醉的患者的 PPC 集中管理包由这些干预措施与常规护理组成。我们假设这以麻醉为中心的捆绑，重点关注围手术期肺复张，将最大限度地减少多次和导致围手术期肺功能障碍并降低 PPC 发生率的协同因素。到为了检验这个假设，我们将使用之前发布的 5 点量表来比较参与者的 PPC 严重程度基于干预组之间手术后前 7 天内最严重的 PPC。作为该研究的统计和数据协调中心将：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新的、临床可行的以麻醉为中心的策略，以减少开腹手术后的 PPC。