Department of Orthopaedics, Zhongda Hospital, School of Medicine, Southeast University, No. 87 Ding Jia Qiao, Nanjing, Jiangsu, 210009, People's Republic of China.
Orthopaedic Trauma Institute (OTI), Southeast University, No. 87 Ding Jia Qiao, Nanjing, Jiangsu, 210009, People's Republic of China.
Trials. 2023 Apr 18;24(1):280. doi: 10.1186/s13063-023-07308-x.
Postoperative pulmonary complications (PPCs) are prevalent in geriatric patients with hip fractures. Low oxygen level is one of the most important risk factors for PPCs. Prone position has been proven efficacy in improving oxygenation and delaying the progress of pulmonary diseases, especially in patients with acute respiratory distress syndrome induced by multiple etiologies. The application of awake prone position (APP) has also attracted widespread attention in recent years. A randomized controlled trial (RCT) will be carried out to measure the effect of postoperative APP in a population of geriatric patients undergoing hip fracture surgery.
This is an RCT. Patients older than 65 years old admitted through the emergency department and diagnosed with an intertrochanteric or femoral neck fracture will be eligible for enrollment and assigned randomly to the control group with routine postoperative management of orthopedics or APP group with an additional prone position for the first three consecutive postoperative days (PODs). Patients receiving conservative treatment will not be eligible for enrollment. We will record the difference in the patient's room-air-breathing arterial partial pressure of oxygen (PaO) values between the 4 POD (POD 4) and emergency visits, the morbidity of PPCs and other postoperative complications, and length of stay. The incidence of PPCs, readmission rates, and mortality rates will be followed up for 90 PODs.
We describe the protocol for a single-center RCT that will evaluate the efficacy of postoperative APP treatment in reducing pulmonary complications and improving oxygenation in geriatric patients with hip fractures.
This protocol was approved by the independent ethics committee (IEC) for Clinical Research of Zhongda Hospital, Affiliated to Southeast University, and is registered on the Chinese Clinical Trial Registry. The findings of the trial will be disseminated through peer-reviewed journals.
2021ZDSYLL203-P01 TRIAL REGISTRATION: ChiCTR ChiCTR2100049311 . Registered on 29 July 2021.
Recruiting. Recruitment is expected to be completed in December 2024.
术后肺部并发症（PPCs）在老年髋部骨折患者中较为常见。低氧血症是 PPCs 的最重要危险因素之一。俯卧位已被证明可有效改善氧合并延缓肺部疾病的进展，尤其是在由多种病因引起的急性呼吸窘迫综合征患者中。近年来，清醒俯卧位（APP）的应用也引起了广泛关注。一项随机对照试验（RCT）将针对老年髋部骨折手术患者群体，测量术后 APP 的效果。
这是一项 RCT。通过急诊科收治并诊断为股骨转子间或股骨颈骨折的 65 岁以上患者将有资格入组并随机分配至骨科常规术后管理的对照组或术后连续 3 天额外俯卧位的 APP 组（第 4 天）。接受保守治疗的患者将没有资格入组。我们将记录患者在第 4 天（第 4 天）与急诊就诊时的室息呼吸动脉部分氧分压（PaO）值的差异、PPCs 等术后并发症的发病率和住院时间。将对 90 天内的 PPCs 发病率、再入院率和死亡率进行随访。
我们描述了一项单中心 RCT 的方案，该方案将评估术后 APP 治疗在减少老年髋部骨折患者肺部并发症和改善氧合方面的疗效。
该方案获得了东南大学附属中大医院独立临床研究伦理委员会（IEC）的批准，并在中国临床试验注册中心注册。试验结果将通过同行评议期刊传播。
2021ZDSYLL203-P01
ChiCTR ChiCTR2100049311，于 2021 年 7 月 29 日注册。
招募中。预计 2024 年 12 月完成招募。
