Department of Anesthesiology, Division of Critical Care Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Critical Illness, Brain Dysfunction, and Survivorship (CIBS) Center, Nashville, Tennessee, USA.
BMJ Open. 2024 Oct 26;14(10):e086946. doi: 10.1136/bmjopen-2024-086946.
Sedation in mechanically ventilated adults in the intensive care unit (ICU) is commonly achieved with intravenous infusions of propofol, dexmedetomidine or benzodiazepines. Significant limitations associated with each can impact their usage. Inhaled isoflurane has potential benefit for ICU sedation due to its safety record, sedation profile, lack of metabolism and accumulation, and fast wake-up time. Administration in the ICU has historically been restricted by the lack of a safe and effective delivery system for the ICU. The Sedaconda Anaesthetic Conserving Device-S (Sedaconda ACD-S) has enabled the delivery of inhaled volatile anaesthetics for sedation with standard ICU ventilators, but it has not yet been rigorously evaluated in the USA. We aim to evaluate the efficacy and safety of inhaled isoflurane delivered via the Sedaconda ACD-S compared with intravenous propofol for sedation of mechanically ventilated ICU adults in USA hospitals.
INhaled Sedation versus Propofol in REspiratory failure in the ICU (INSPiRE-ICU1) is a phase 3, multicentre, randomised, controlled, open-label, assessor-blinded trial that aims to enrol 235 critically ill adults in 14 hospitals across the USA. Eligible patients are randomised in a 1.5:1 ratio for a treatment duration of up to 48 (±6) hours or extubation, whichever occurs first, with primary follow-up period of 30 days and additional follow-up to 6 months. Primary outcome is percentage of time at target sedation range. Key secondary outcomes include use of opioids during treatment, spontaneous breathing efforts during treatment, wake-up time at end of treatment and cognitive recovery after treatment.
Trial protocol has been approved by US Food and Drug Administration (FDA) and central (Advarra SSU00208265) or local institutional review boards ((IRB), Cleveland Clinic IRB FWA 00005367, Tufts HS IRB 20221969, Houston Methodist IRB PRO00035247, Mayo Clinic IRB Mod22-001084-08, University of Chicago IRB21-1917-AM011 and Intermountain IRB 033175). Results will be presented at scientific conferences, submitted for publication, and provided to the FDA.
NCT05312385.
在重症监护病房（ICU）中，机械通气的成人镇静通常通过静脉输注丙泊酚、右美托咪定或苯二氮䓬类药物来实现。每种药物都有其显著的局限性，这可能会影响其使用。由于其安全性记录、镇静谱、无代谢和蓄积以及快速苏醒时间，吸入异氟醚在 ICU 镇静方面具有潜在益处。然而，由于缺乏 ICU 中安全有效的输送系统，其在 ICU 中的应用一直受到限制。Sedaconda 麻醉保存装置-S（Sedaconda ACD-S）使通过标准 ICU 呼吸机输送吸入挥发性麻醉剂用于镇静成为可能，但尚未在美国进行严格评估。我们旨在评估通过 Sedaconda ACD-S 给予吸入异氟醚与静脉内给予丙泊酚相比，用于美国医院机械通气 ICU 成人镇静的疗效和安全性。
INSPiRE-ICU1 是一项多中心、随机、对照、开放性、评估者设盲的 3 期临床试验，旨在美国 14 家医院纳入 235 名危重症成人。符合条件的患者以 1.5:1 的比例随机分组，治疗时间最长为 48（±6）小时或拔管，以先发生者为准，主要随访期为 30 天，额外随访至 6 个月。主要结局是目标镇静范围的时间百分比。关键次要结局包括治疗期间使用阿片类药物、治疗期间自主呼吸努力、治疗结束时苏醒时间和治疗后认知恢复。
试验方案已获得美国食品和药物管理局（FDA）和中央（Advarra SSU00208265）或当地机构审查委员会（IRB）的批准（克利夫兰诊所 IRB FWA 00005367、塔夫茨 HS IRB 20221969、休斯顿卫理公会 IRB PRO00035247、梅奥诊所 IRB Mod22-001084-08、芝加哥大学 IRB21-1917-AM011 和 Intermountain IRB 033175）。结果将在科学会议上公布，提交发表，并提供给 FDA。
NCT05312385。
