Buggeskov Katrine B, Jakobsen Janus C, Secher Niels H, Jonassen Thomas, Andersen Lars W, Steinbrüchel Daniel A, Wetterslev Jørn
Department of Cardiothoracic Anaesthesiology, The Heart Centre, Rigshospitalet 4142, Blegdamsvej 9, DK-2100 Copenhagen, Denmark.
Trials. 2014 Dec 23;15:510. doi: 10.1186/1745-6215-15-510.
Pulmonary dysfunction complicates cardiac surgery that includes cardiopulmonary bypass. The pulmonary protection trial evaluates effect of pulmonary perfusion on pulmonary function in patients suffering from chronic obstructive pulmonary disease. This paper presents the statistical plan for the main publication to avoid risk of outcome reporting bias, selective reporting, and data-driven results as an update to the published design and method for the trial.
The pulmonary protection trial is a randomized, parallel group clinical trial that assesses the effect of pulmonary perfusion with oxygenated blood or Custodiol™ HTK (histidine-tryptophan-ketoglutarate) solution versus no pulmonary perfusion in 90 chronic obstructive pulmonary disease patients. Patients, the statistician, and the conclusion drawers are blinded to intervention allocation. The primary outcome is the oxygenation index from 10 to 15 minutes after the end of cardiopulmonary bypass until 24 hours thereafter. Secondary outcome measures are oral tracheal intubation time, days alive outside the intensive care unit, days alive outside the hospital, and 30- and 90-day mortality, and one or more of the following selected serious adverse events: pneumothorax or pleural effusion requiring drainage, major bleeding, reoperation, severe infection, cerebral event, hyperkaliemia, acute myocardial infarction, cardiac arrhythmia, renal replacement therapy, and readmission for a respiratory-related problem.
The pulmonary protection trial investigates the effect of pulmonary perfusion during cardiopulmonary bypass in chronic obstructive pulmonary disease patients. A preserved oxygenation index following pulmonary perfusion may indicate an effect and inspire to a multicenter confirmatory trial to assess a more clinically relevant outcome.
ClinicalTrials.gov identifier: NCT01614951, registered on 6 June 2012.
肺功能障碍使包括体外循环的心脏手术变得复杂。肺保护试验评估了肺灌注对慢性阻塞性肺疾病患者肺功能的影响。本文给出主要出版物的统计计划，以避免结果报告偏倚、选择性报告和数据驱动结果的风险，作为该试验已发表设计和方法的更新内容。
肺保护试验是一项随机、平行组临床试验，评估在90例慢性阻塞性肺疾病患者中，用氧合血或HTK液（组氨酸 - 色氨酸 - 酮戊二酸）进行肺灌注与不进行肺灌注的效果。患者、统计学家和结论得出者对干预分配情况不知情。主要结局是体外循环结束后10至15分钟直至此后24小时的氧合指数。次要结局指标包括气管插管时间、重症监护室外存活天数、院外存活天数、30天和90天死亡率，以及以下一种或多种选定的严重不良事件：需要引流的气胸或胸腔积液、大出血、再次手术、严重感染、脑部事件、高钾血症、急性心肌梗死、心律失常、肾脏替代治疗以及因呼吸相关问题再次入院。
肺保护试验研究了慢性阻塞性肺疾病患者体外循环期间肺灌注的效果。肺灌注后氧合指数保持良好可能表明存在效果，并促使开展多中心验证性试验以评估更具临床相关性的结局。
ClinicalTrials.gov标识符：NCT01614951，于2012年6月6日注册。
