Department of Anesthesiology, Shengjing Hospital of China Medical University, Shenyang, China.
Department of Anesthesiology, The Affiliated Hospital of Qingdao University, Qingdao, China.
BMC Geriatr. 2023 Sep 21;23(1):581. doi: 10.1186/s12877-023-04125-4.
Perioperative brain protection in older patients has been the focus of research recently; meanwhile, exploring the relationship between regional cerebral oxygen saturation (rSO) and brain function in the perioperative period has been an emerging and challenging area-the difficulties related to the real-time monitoring of rSO and the choice of feasible interventions. As an advanced instrument for intraoperative rSO monitoring, the clinical application of near-infrared spectrum (NIRS) cerebral oxygen monitoring has gradually increased in popularity and is being recognized for its beneficial clinical outcomes in patients undergoing cardiac and noncardiac surgery. In addition, although sufficient evidence to support this hypothesis is still lacking, the effect of permissive hypercapnia (PHC) on rSO has expanded from basic research to clinical exploration. Therefore, monitoring intraoperative rSO in older patients with NIRS technology and exploring possible interventions that may change rSO and even improve postoperative cognitive performance is significant and clinically valuable.
This study is a single-center randomized controlled trial (RCT). 76 older patients are enrolled as subjects. Patients who meet the screening criteria will be randomly assigned 1:1 to the control and intervention groups. PHC-based mechanical ventilation will be regarded as an intervention. The primary outcome is the absolute change in the percent change in rSO from baseline to the completion of surgery in the intervention and control groups. Secondary outcomes mainly include observations of intraoperative cerebral oxygenation and metabolism, markers of brain injury, and assessments of patients' cognitive function using scale through postoperative follow-up.
The findings of this RCT will reveal the effect of PHC on intraoperative rSO in older patients with nonacute fragile brain function (NFBF) and the approximate trends over time, and differences in postoperative cognitive function outcomes. We anticipate that the trial results will inform clinical policy decision-makers in clinical practice, enhance the management of intraoperative cerebral oxygen monitoring in older patients with comorbid NFBF, and provide guidance for clinical brain protection and improved postoperative cognitive function outcomes.
ChiCTR, ChiCTR2200062093, Registered 9/15/2022.
围手术期老年患者的脑保护一直是研究的重点;同时,探索围手术期局部脑氧饱和度(rSO)与脑功能之间的关系也是一个新兴且具有挑战性的领域——其难点在于 rSO 的实时监测和可行干预措施的选择。近红外光谱(NIRS)脑氧监测作为一种术中 rSO 监测的先进仪器,其临床应用逐渐普及,并因其在心脏和非心脏手术患者中的有益临床结局而得到认可。此外,尽管支持这一假说的充分证据仍然缺乏,但允许性高碳酸血症(PHC)对 rSO 的影响已从基础研究扩展到临床探索。因此,使用 NIRS 技术监测老年患者术中 rSO,并探索可能改变 rSO 甚至改善术后认知功能的干预措施具有重要的临床意义。
这是一项单中心随机对照试验(RCT)。将 76 名老年患者纳入研究对象。符合筛选标准的患者将按 1:1 随机分配至对照组和干预组。以 PHC 为基础的机械通气将作为干预措施。主要结局是干预组和对照组从基线到手术完成时 rSO 变化的绝对百分比变化。次要结局主要包括观察术中脑氧合和代谢、脑损伤标志物以及通过术后随访使用量表评估患者的认知功能。
该 RCT 的结果将揭示允许性高碳酸血症对非急性脆弱性脑功能(NFBF)老年患者术中 rSO 的影响及其随时间的大致趋势,以及术后认知功能结局的差异。我们预计试验结果将为临床决策者提供信息,以指导临床实践,增强对合并 NFBF 的老年患者术中脑氧监测的管理,并为临床脑保护和改善术后认知功能结局提供指导。
ChiCTR,ChiCTR2200062093,于 2022 年 9 月 15 日注册。