Valkenet Karin, Trappenburg Jaap Ca, Gosselink Rik, Sosef Meindert N, Willms Jerome, Rosman Camiel, Pieters Heleen, Scheepers Joris Jg, de Heus Saskia C, Reynolds John V, Guinan Emer, Ruurda Jelle P, Rodrigo Els He, Nafteux Philippe, Fontaine Marianne, Kouwenhoven Ewout A, Kerkemeyer Margot, van der Peet Donald L, Hania Sylvia W, van Hillegersberg Richard, Backx Frank Jg
Department of Rehabilitation, Nursing Science and Sports, University Medical Center Utrecht, PO Box 85500, Utrecht 3508 GA, The Netherlands.
Trials. 2014 Apr 27;15:144. doi: 10.1186/1745-6215-15-144.
Esophageal resection is associated with a high incidence of postoperative pneumonia. Respiratory complications account for almost half of the readmissions to the critical care unit. Postoperative complications can result in prolonged hospital stay and consequently increase healthcare costs. In cardiac surgery a preoperative inspiratory muscle training program has shown to prevent postoperative pneumonia and reduce length of hospital stay. While in some surgical centers inspiratory muscle training is already used in the preoperative phase in patients undergoing esophageal resection, the added value of this intervention on the reduction of pulmonary complications has not yet been investigated in large surgical populations other than cardiac surgery in a randomized and controlled study design.
METHODS/DESIGN: The effect of a preoperative inspiratory muscle training program on the incidence of postoperative pneumonia in patients undergoing esophageal resection will be studied in a single blind multicenter randomized controlled trial (the PREPARE study). In total 248 patients (age >18 years) undergoing esophageal resection for esophageal cancer will be included in this study. They are randomized to either usual care or usual care with an additional inspiratory muscle training intervention according to a high-intensity protocol which is performed with a tapered flow resistive inspiratory loading device. Patients have to complete 30 dynamic inspiratory efforts twice daily for 7 days a week until surgery with a minimum of 2 weeks. The starting training load will be aimed to be 60% of maximal inspiratory pressure and will be increased based on the rate of perceived exertion.The main study endpoint is the incidence of postoperative pneumonia. Secondary objectives are to evaluate the effect of preoperative inspiratory muscle training on length of hospital stay, duration of mechanical ventilation, incidence of other postoperative (pulmonary) complications, quality of life, and on postoperative respiratory muscle function and lung function.
The PREPARE study is the first multicenter randomized controlled trial to evaluate the hypothesis that preoperative inspiratory muscle training leads to decreased pulmonary complications in patients undergoing esophageal resection.
NCT01893008.
食管切除术与术后肺炎的高发生率相关。呼吸并发症几乎占重症监护病房再入院病例的一半。术后并发症可导致住院时间延长，从而增加医疗费用。在心脏手术中，术前吸气肌训练计划已被证明可预防术后肺炎并缩短住院时间。虽然在一些外科中心，吸气肌训练已在接受食管切除术的患者的术前阶段使用，但除心脏手术外，在其他大型外科人群中，尚未通过随机对照研究设计对这种干预措施在减少肺部并发症方面的附加价值进行研究。
方法/设计：一项单盲多中心随机对照试验（PREPARE研究）将研究术前吸气肌训练计划对接受食管切除术患者术后肺炎发生率的影响。本研究将总共纳入248例（年龄>18岁）因食管癌接受食管切除术的患者。他们将被随机分为常规护理组或接受额外吸气肌训练干预的常规护理组，该干预根据高强度方案进行，使用锥形流量阻力吸气负荷装置。患者必须每周7天，每天两次完成30次动态吸气努力，持续7天，直至手术，最短持续2周。起始训练负荷将目标设定为最大吸气压力的60%，并根据主观用力程度进行增加。主要研究终点是术后肺炎的发生率。次要目标是评估术前吸气肌训练对住院时间、机械通气持续时间、其他术后（肺部）并发症发生率、生活质量以及术后呼吸肌功能和肺功能的影响。
PREPARE研究是第一项多中心随机对照试验，旨在评估术前吸气肌训练可降低接受食管切除术患者肺部并发症这一假设。
NCT01893008。
