Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, China.
Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, China
BMJ Open. 2022 Aug 30;12(8):e059741. doi: 10.1136/bmjopen-2021-059741.
Sedation and analgesia are recommended to be employed in the intensive care unit (ICU) to enhance patient comfort and safety, facilitate mechanical ventilation and reduce oxygen demands. However, the increasing evidence demonstrates that excessive sedation and analgesia might prolong mechanical ventilation and increase costs and mortality. Acupuncture is known to be able to attenuate pain, anxiety and agitation symptoms while avoiding excessive sedation and analgesia caused by drugs. Therefore, we present a protocol to investigate whether acupuncture, used for sedation and analgesia, can reduce the duration of mechanical ventilation, save medical resources and reduce the mortality of critically ill patients receiving mechanical ventilation.
Prospective, randomised controlled trial is conducted on 180 adult medical/surgical ICU patients with mechanical ventilation needing sedation at 3 ICUs between 03 November 2021 and 16 August 2023. Patients will be treated with analgesia and sedation to achieve desired target sedation levels (Richmond Agitation Sedation Score of -2 to 1). Enrolled patients will be randomly assigned in a ratio of 1:1:1 to receive deep needle insertion with combined manual and alternating-mode electrical stimulation on acupoints (AC group), superficial needle insertion without manual stimulation and electrical stimulation on non-acupoints (SAC group), or no acupuncture intervention (NAC group). The primary outcome is the duration of mechanical ventilation from randomisation until patients are free of mechanical ventilation (including non-invasive) without reinstitution for the following 48 hours. Secondary endpoints include the dose of administered sedatives and analgesic at comparable sedation levels throughout the study, ICU length of stay, hospital length of stay. Additional outcomes include the prevalence and days of delirium in ICU, mortality in ICU and within 28 days after randomisation, and the number of ventilator free days in 28 days.
This trial was approved by the ethics committee at Guangdong Provincial Hospital of Chinese Medicine. We will publish the study results.
ChiCTR2100052650.
在重症监护病房（ICU）中推荐使用镇静和镇痛来提高患者舒适度和安全性，促进机械通气并降低氧需求。然而，越来越多的证据表明，过度的镇静和镇痛可能会延长机械通气时间，并增加成本和死亡率。针刺已被证明能够减轻疼痛、焦虑和躁动症状，同时避免药物引起的过度镇静和镇痛。因此，我们提出了一个方案，以研究针刺是否可以减少机械通气时间，节约医疗资源，并降低接受机械通气的危重症患者的死亡率。
在 2021 年 11 月 3 日至 2023 年 8 月 16 日期间，在 3 个 ICU 中对 180 名需要镇静的成年内科/外科 ICU 机械通气患者进行前瞻性、随机对照试验。患者将接受镇痛和镇静治疗，以达到所需的目标镇静水平（Richmond 躁动镇静评分-2 至 1）。纳入的患者将以 1:1:1 的比例随机分配接受深针刺入联合穴位手动和交替模式电刺激（AC 组）、非穴位浅针刺入无手动刺激和电刺激（SAC 组）或无针刺干预（NAC 组）。主要结局是从随机分组到患者无需机械通气（包括无创）的时间，且在接下来的 48 小时内无需重新开始机械通气。次要结局包括在整个研究过程中在可比镇静水平下给予镇静剂和镇痛药的剂量、ICU 住院时间、医院住院时间。其他结局包括 ICU 中谵妄的发生率和天数、随机分组后 ICU 和 28 天内的死亡率，以及 28 天内无呼吸机天数。
这项试验已获得广东省中医院伦理委员会的批准。我们将发表研究结果。
ChiCTR2100052650。
