Marjanovic Nicolas, Frasca Denis, Asehnoune Karim, Paugam Catherine, Lasocki Sigismond, Ichai Carole, Lefrant Jean-Yves, Leone Marc, Dahyot-Fizelier Claire, Pottecher Julien, Falcon Dominique, Veber Benoit, Constantin Jean-Michel, Seguin Sabrina, Guénézan Jérémy, Mimoz Olivier
Department of Emergency and Prehospital Care, Centre Hospitalier Universitaire de Poitiers, Poitiers, France.
INSERM UMR1246-Methods in Patient-Centered Outcomes and Health Research, Poitiers, France.
BMJ Open. 2017 Aug 7;7(8):e017003. doi: 10.1136/bmjopen-2017-017003.
Severe trauma represents the leading cause of mortality worldwide. While 80% of deaths occur within the first 24 hours after trauma, 20% occur later and are mainly due to healthcare-associated infections, including ventilator-associated pneumonia (VAP). Preventing underinflation of the tracheal cuff is recommended to reduce microaspiration, which plays a major role in the pathogenesis of VAP. Automatic devices facilitate the regulation of tracheal cuff pressure, and their implementation has the potential to reduce VAP. The objective of this work is to determine whether continuous regulation of tracheal cuff pressure using a pneumatic device reduces the incidence of VAP compared with intermittent control in severe trauma patients.
This multicentre randomised controlled and open-label trial will include patients suffering from severe trauma who are admitted within the first 24 hours, who require invasive mechanical ventilation to longer than 48 hours. Their tracheal cuff pressure will be monitored either once every 8 hours (control group) or continuously using a pneumatic device (intervention group). The primary end point is the proportion of patients that develop VAP in the intensive care unit (ICU) at day 28. The secondary end points include the proportion of patients that develop VAP in the ICU, early (≤7 days) or late (>7 days) VAP, time until the first VAP diagnosis, the number of ventilator-free days and antibiotic-free days, the length of stay in the ICU, the proportion of patients with ventilator-associated events and that die during their ICU stay.
This protocol has been approved by the ethics committee of Poitiers University Hospital, and will be carried out according to the principles of the Declaration of Helsinki and the Good Clinical Practice guidelines. The results of this study will be disseminated through presentation at scientific conferences and publication in peer-reviewed journals.
Clinical Trials NCT02534974.
严重创伤是全球范围内主要的死亡原因。虽然80%的死亡发生在创伤后的最初24小时内，但20%发生在之后，主要是由于医疗相关感染，包括呼吸机相关性肺炎（VAP）。建议防止气管插管气囊充气不足以减少微量误吸，微量误吸在VAP的发病机制中起主要作用。自动装置有助于调节气管插管气囊压力，其应用有可能降低VAP的发生率。这项研究的目的是确定与间歇性控制相比，使用气动装置持续调节气管插管气囊压力是否能降低严重创伤患者VAP的发生率。
这项多中心随机对照开放标签试验将纳入在最初24小时内入院、需要有创机械通气超过48小时的严重创伤患者。他们的气管插管气囊压力将每8小时监测一次（对照组）或使用气动装置持续监测（干预组）。主要终点是第28天时重症监护病房（ICU）中发生VAP的患者比例。次要终点包括ICU中发生VAP的患者比例、早期（≤7天）或晚期（>7天）VAP、首次诊断VAP的时间、无呼吸机天数和无抗生素天数、在ICU的住院时间、发生呼吸机相关事件的患者比例以及在ICU住院期间死亡的患者比例。
本方案已获得普瓦捷大学医院伦理委员会的批准，并将按照《赫尔辛基宣言》和《良好临床实践指南》的原则进行。本研究结果将通过在科学会议上报告和在同行评审期刊上发表进行传播。
临床试验编号NCT02534974。
