Wong Jean, Lam David, Choi Stephen, Singh Mandeep, Siddiqui Naveed, Sockalingam Sanjeev, Chung Frances
Department of Anesthesia, Toronto Western Hospital, University Health Network, University of Toronto, 399 Bathurst Street, Toronto, ON, M5T 2S8, Canada.
Department of Anaesthesia, Sunnybrook Health Sciences Center, University of Toronto, Toronto, ON, Canada.
BMC Anesthesiol. 2018 Jan 3;18(1):1. doi: 10.1186/s12871-017-0465-5.
Delirium is a common problem that occurs in 5-50% of elderly individuals following surgery. Patients who develop delirium after surgery are at increased risk for serious complications. Recent studies suggest that patients with obstructive sleep apnea (OSA), a sleep disorder characterized by repeated episodes of complete or partial blockage of the upper airway - are at greater risk to develop delirium. OSA is more common in elderly individuals but is often undiagnosed. Identification and treatment of unrecognized OSA may reduce the incidence of postoperative delirium. However, few studies have investigated the effect of perioperative treatment of OSA to prevent postoperative delirium.
This multi-centre randomized controlled trial will enrol 634 elderly patients undergoing elective hip/knee replacement surgery. The study has been approved by the Research Ethics Boards of the three participating institutions. Patients will be screened with the STOP-Bang questionnaire. Those with a score of 3 or greater will have a portable home sleep study using the ApneaLink™ Air device. Patients identified to have OSA will be randomized to 1) Auto-titrating continuous positive airway pressure (APAP) applied during sleep for 72 h after surgery or until discharge if they are discharged before 72 h or 2) Control group - routine care, no APAP. All patients will be evaluated for delirium for 72 h after surgery or until discharge if they are discharged before 72 h. The primary outcome is the occurrence of delirium - assessed twice daily using the Confusion Assessment Method for 72 h or until discharge if the hospital stay is <72 h.
Delirium is associated with increased morbidity and mortality, and higher healthcare costs. With the aging population, the incidence of postoperative delirium will likely increase as the number of elderly individuals undergoing surgery rises. The results of our study will be published in a peer-reviewed journal and presented at local and international medical conferences. Our study findings may lead to improved surgical outcomes, enhanced patient safety and reduced healthcare costs.
This study was retrospectively registered at clinicaltrials.gov NCT02954224 on November 3, 2016.
谵妄是一个常见问题，在5%至50%的老年患者术后会出现。术后发生谵妄的患者出现严重并发症的风险增加。最近的研究表明，患有阻塞性睡眠呼吸暂停（OSA）的患者——一种以上呼吸道完全或部分反复阻塞为特征的睡眠障碍——发生谵妄的风险更高。OSA在老年人中更为常见，但往往未被诊断出来。识别和治疗未被认识到的OSA可能会降低术后谵妄的发生率。然而，很少有研究调查围手术期治疗OSA对预防术后谵妄的效果。
这项多中心随机对照试验将招募634名接受择期髋关节/膝关节置换手术的老年患者。该研究已获得三个参与机构的研究伦理委员会批准。患者将使用STOP-Bang问卷进行筛查。得分3分或更高的患者将使用ApneaLink™ Air设备进行便携式家庭睡眠研究。被确定患有OSA的患者将被随机分为1）术后睡眠期间应用自动调压持续气道正压通气（APAP）72小时，或如果在72小时前出院则持续至出院；2）对照组——常规护理，不使用APAP。所有患者将在术后72小时或如果在72小时前出院则持续至出院时接受谵妄评估。主要结局是谵妄的发生——使用谵妄评估方法每天评估两次，持续72小时，或如果住院时间<72小时则持续至出院。
谵妄与发病率和死亡率增加以及更高的医疗成本相关。随着人口老龄化，随着接受手术的老年人数量增加，术后谵妄的发生率可能会上升。我们研究的结果将发表在同行评审期刊上，并在当地和国际医学会议上展示。我们的研究结果可能会改善手术结局、提高患者安全性并降低医疗成本。
本研究于2016年11月3日在clinicaltrials.gov上进行回顾性注册，注册号为NCT02954224。
