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在印度农村的三家医院中分担椎管内麻醉护理任务:一项非劣效性随机对照临床试验。

Task-sharing spinal anaesthesia care in three rural Indian hospitals: a non-inferiority randomised controlled clinical trial.

机构信息

ASHWINI Gudalur Adivasi Hospital, Gudalur, Tamil Nadu, India.

Tribal Health Initiative, Sittilingi, Tamil Nadu, India.

出版信息

BMJ Glob Health. 2024 Aug 16;9(8):e014170. doi: 10.1136/bmjgh-2023-014170.

DOI:10.1136/bmjgh-2023-014170
PMID:39153752
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11331853/
Abstract

BACKGROUND

Task-sharing of spinal anaesthesia care by non-specialist graduate physicians, termed medical officers (MOs), is commonly practised in rural Indian healthcare facilities to mitigate workforce constraints. We sought to assess whether spinal anaesthesia failure rates of MOs were non-inferior to those of consultant anaesthesiologists (CA) following a standardised educational curriculum.

METHODS

We performed a randomised, non-inferiority trial in three rural hospitals in Tamil Nadu and Chhattisgarh, India. Patients aged over 18 years with low perioperative risk (ASA I & II) were randomised to receive MO or CA care. Prior to the trial, MOs underwent task-based anaesthesia training, inclusive of remotely accessed lectures, simulation-based training and directly observed anaesthetic procedures and intraoperative care. The primary outcome measure was spinal anaesthesia failure with a non-inferiority margin of 5%. Secondary outcome measures consisted of incidence of perioperative and postoperative complications.

FINDINGS

Between 12 July 2019 and 8 June 2020, a total of 422 patients undergoing surgical procedures amenable to spinal anaesthesia care were randomised to receive either MO (231, 54.7%) or CA care (191, 45.2%). Spinal anaesthesia failure rate for MOs (7, 3.0%) was non-inferior to those of CA (5, 2.6%); difference in success rate of 0.4% (95% CI=0.36-0.43%; p=0.80). Additionally, there were no statistically significant differences observed between the two groups for intraoperative or postoperative complications, or patients' experience of pain during the procedure.

INTERPRETATION

This study demonstrates that failure rates of spinal anaesthesia care provided by trained MOs are non-inferior to care provided by CAs in low-risk surgical patients. This may support policy measures that use task-sharing as a means of expanding anaesthesia care capacity in rural Indian hospitals.

TRIAL REGISTRATION NUMBER

NCT04438811.

摘要

背景

在印度农村医疗机构中,非专科毕业的住院医师(称为医务官)分担椎管内麻醉护理工作,这是一种常见的做法,旨在缓解劳动力短缺的问题。我们旨在评估在经过标准化教育课程培训后,医务官的椎管内麻醉失败率是否不劣于顾问麻醉师(CA)。

方法

我们在印度泰米尔纳德邦和恰蒂斯加尔邦的三家农村医院进行了一项随机、非劣效性试验。纳入年龄在 18 岁以上、围手术期风险低(ASA I & II)的患者,随机接受医务官或 CA 护理。在试验之前,医务官接受了基于任务的麻醉培训,包括远程访问讲座、模拟培训以及直接观察麻醉程序和术中护理。主要结局指标是椎管内麻醉失败,非劣效性边界为 5%。次要结局指标包括围手术期和术后并发症的发生率。

结果

在 2019 年 7 月 12 日至 2020 年 6 月 8 日期间,共有 422 名接受可进行椎管内麻醉护理的手术的患者被随机分配接受医务官(231 名,54.7%)或 CA 护理(191 名,45.2%)。医务官的椎管内麻醉失败率为 7 例(3.0%),不劣于 CA 的失败率(5 例,2.6%);成功率差异为 0.4%(95%CI=0.36-0.43%;p=0.80)。此外,两组患者在术中或术后并发症,或患者在手术过程中的疼痛体验方面,均未观察到统计学上的显著差异。

结论

这项研究表明,经过培训的医务官提供的椎管内麻醉护理失败率不劣于 CA 为低风险手术患者提供的护理。这可能支持利用任务分担作为在印度农村医院扩大麻醉护理能力的政策措施。

试验注册号

NCT04438811。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7bbe/11331853/acf09b44ad56/bmjgh-9-8-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7bbe/11331853/acf09b44ad56/bmjgh-9-8-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7bbe/11331853/acf09b44ad56/bmjgh-9-8-g001.jpg

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