Department of Medicine, Division of Pulmonary, Allergy, & Critical Care Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA
Veterans Integrated Service Network 7, Department of Veterans Affairs, Washington, District of Columbia, USA.
BMJ Open. 2020 Sep 18;10(9):e036671. doi: 10.1136/bmjopen-2019-036671.
Cardiovascular collapse is a common complication during tracheal intubation of critically ill adults. Whether administration of an intravenous fluid bolus prevents cardiovascular collapse during tracheal intubation remains uncertain. A prior randomised trial found fluid bolus administration to be ineffective overall but suggested potential benefit for patients receiving positive pressure ventilation during tracheal intubation.
The PREventing cardiovascular collaPse with Administration of fluid REsuscitation during Induction and Intubation (PREPARE II) trial is a prospective, multi-centre, non-blinded randomised trial being conducted in 13 academic intensive care units in the USA. The trial will randomise 1065 critically ill adults undergoing tracheal intubation with planned use of positive pressure ventilation (non-invasive ventilation or bag-mask ventilation) between induction and laryngoscopy to receive 500 mL of intravenous crystalloid or no intravenous fluid bolus. The primary outcome is cardiovascular collapse, defined as any of: systolic blood pressure <65 mm Hg, new or increased vasopressor administration between induction and 2 min after intubation, or cardiac arrest or death between induction and 1 hour after intubation. The primary analysis will be an unadjusted, intention-to-treat comparison of the primary outcome between patients randomised to fluid bolus administration and patients randomised to no fluid bolus administration using a χ test. The sole secondary outcome is 28-day in-hospital mortality. Enrolment began on 1 February 2019 and is expected to conclude in June 2020.
The trial was approved by either the central institutional review board at Vanderbilt University Medical Center or the local institutional review board at each trial site. Results will be submitted for publication in a peer-reviewed journal and presented at scientific conferences.
NCT03787732.
心血管崩溃是危重病患者气管插管的常见并发症。在气管插管期间给予静脉输液是否能预防心血管崩溃仍不确定。先前的一项随机试验发现，总体来说，液体冲击疗法无效，但提示在气管插管期间接受正压通气的患者可能有潜在获益。
预防诱导和插管期间输液复苏引起的心血管崩溃（PREPARE II）试验是一项在美国 13 个学术性重症监护病房进行的前瞻性、多中心、非盲随机试验。该试验将随机分配 1065 名接受气管插管的危重病患者，计划在诱导和喉镜检查之间使用正压通气（无创通气或球囊面罩通气），以接受 500 毫升静脉晶体液或不接受静脉液体冲击。主要结局是心血管崩溃，定义为以下任何一种情况：收缩压<65mmHg，诱导至插管后 2 分钟之间新的或增加血管加压药的使用，或诱导至插管后 1 小时之间发生心脏骤停或死亡。主要分析将是对接受液体冲击疗法和不接受液体冲击疗法的患者进行未调整的、意向治疗的主要结局比较，使用 χ2 检验。唯一的次要结局是 28 天院内死亡率。招募于 2019 年 2 月 1 日开始，预计于 2020 年 6 月结束。
该试验得到范德比尔特大学医学中心的中央机构审查委员会或每个试验地点的当地机构审查委员会的批准。结果将提交给同行评议的期刊发表，并在科学会议上展示。
NCT03787732。
