背景:最近的荟萃分析和随机研究表明,在接受血管内血栓切除术的急性缺血性卒中患者中,与局部麻醉和镇静相比,机械通气全身麻醉具有更好的功能状态,他们推荐它的使用。但是一旦程序完成,拔管的最佳时刻是什么时候?目前,没有指南推荐拔管的最佳时机。机械通气时间延长可能与由于大多数麻醉药物产生的血管舒张而导致的肺炎或脑血流紊乱等并发症增加有关。然而,中风患者过早拔管可能导致躁动等并发症,迷失方向,废除了反射,血压突然波动,脑血流的改变,呼吸窘迫,支气管抽吸术,以及重新插管的需要。因此,我们设计了一项随机研究,假设在全身麻醉下血管内血栓切除术治疗急性缺血性卒中3个月后,早期与延迟拔管相比具有更好的功能结局。
方法:该研究者发起,单中心,prospective,平行,评估盲化,优越性,随机对照试验将纳入178例前循环近端闭塞患者,在全身麻醉下成功进行血管内血栓切除术(TICI2b-3)治疗.患者将被随机分配接受手术后早期(<6小时)或延迟(6-12小时)拔管。主要结果指标是90天的功能独立性(mRS为0-2),用修改的Rankin评分(MRS)测量,范围从0(无症状)到6(死亡)。
结论:这将是第一个比较全身麻醉下急性缺血性卒中血管内血栓切除术后机械通气持续时间(早期和延迟拔管)效果的试验。
背景:研究方案于2023年4月11日由圣地亚哥-卢戈研究伦理委员会(CEI-SL)批准,编号2023/127,并在临床试验.gov临床试验注册表中注册。NCT05847309。需要知情同意。参与者招募将于2023年4月18日开始。结果将提交给同行评审的期刊发表,并在一个或多个科学会议上发表。
BACKGROUND: Recent meta-analyses and randomized studies have shown that among patients with acute ischemic stroke undergoing endovascular thrombectomy, general anesthesia with mechanical ventilation is associated with better functional status compared to local anesthesia and sedation, and they recommend its use. But once the procedure is completed, when is the optimal moment for
extubation? Currently, there are no guidelines recommending the optimal moment for
extubation. Prolonged mechanical ventilation time could potentially be linked to increased complications such as pneumonia or disturbances in cerebral blood flow due to the vasodilatation produced by most anesthetic drugs. However, premature
extubation in a patient who has suffered a stroke could led to complications such as agitation, disorientation, abolished reflexes, sudden fluctuations in blood pressure, alterations in cerebral blood flow, respiratory distress, bronchial aspiration, and the need for reintubation. We therefore designed a randomized study hypothesizing that early compared with delayed
extubation is associated with a better functional outcome 3 months after endovascular thrombectomy treatment under general anesthesia for acute ischemic stroke.
METHODS: This investigator-initiated, single-center, prospective, parallel, evaluated blinded, superiority, randomized controlled trial will include 178 patients with a proximal occlusion of the anterior circulation treated with successful endovascular thrombectomy (TICI 2b-3) under general anesthesia. Patients will be randomly allocated to receive early (< 6 h) or delayed (6-12 h)
extubation after the procedure. The primary outcome measure is functional independence (mRS of 0-2) at 90 days, measured with the modified Rankin Score (mRS), ranging from 0 (no symptoms) to 6 (death).
CONCLUSIONS: This will be the first trial to compare the effect of mechanical ventilation duration (early vs delayed extubation) after satisfactory endovascular thrombectomy for acute ischemic stroke under general anesthesia.
BACKGROUND: The study protocol was approved April 11, 2023, by the by the Santiago-Lugo Research Ethics Committee (CEI-SL), number 2023/127, and was registered into the clinicaltrials.gov clinical trials registry with No. NCT05847309. Informed consent is required. Participant recruitment begins on April 18, 2023. The results will be submitted for publication in a peer-reviewed journal and presented at one or more scientific conferences.