Outcomes and evaluation of endoscopic retrograde cholangiopancreatography via Gastro-Laryngeal Tube in adult patients: a prospective randomised control study.

IF 2.9 3区 医学 Q3 ENGINEERING, BIOMEDICAL Expert Review of Medical Devices Pub Date : 2023-07-01 Epub Date: 2023-08-21 DOI:10.1080/17434440.2023.2246871
Anshika Dengre, Rudrashish Haldar, Ashish Kumar Kannaujia, Nidhi Singh, Samir Mohindra, Prabhaker Mishra
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Abstract

Objectives: In conventional endoscopic retrograde cholangiopancreatography (ERCP), the patient lies prone or in a semi-prone position under deep sedation and maintains spontaneous ventilation. Sedative-induced respiratory depression and unprotected airway compromise patients' safety. The gastro-laryngeal tube (G-LT) is a novel reusable supraglottic airway device with two separate ports for endoscopy and ventilation. This study attempts to evaluate the performance characteristic of G-LT.

Methods: One hundred and forty patients undergoing ERCP were enrolled and randomized. In Group G, patients underwent ERCP with G-LT, whereas Group S patients underwent ERCP conventionally. G-LT insertion attempts, esophageal visualization times, vital parameters, propofol consumption, endoscopists' and anesthesiologists' satisfaction scores, time to achieve Modified Aldrete Score of ≥ 9, and complications were recorded.

Results: Both groups showed similar demographic parameters and 100% procedure completion rates. G-LT group showed shortened esophageal visualization times (4.71 ± 1.687 s vs 7.37 ± 1.515 s) and increased propofol consumption (423.14 ± 106.982 mg vs 178.00 ± 100.125 mg). Group G showed better endoscopic maneuvrability and lesser hemodynamic variability. Sore throat, dysphagia, and mucosal trauma were higher in the G-LT group.

Conclusion: G-LT provides less intra-procedural hemodynamic changes, quicker esophageal visualization, and better scope maneuvrability at the cost of higher propofol consumption, sore throat, dysphagia, and mucosal trauma.

Trial registration: Clinical Trial Registry of India CTRI/2021/06/034212 (Registered on: 14/06/2021).

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成人患者经胃喉管内镜逆行胰胆管造影的结果和评价:一项前瞻性随机对照研究。
目的:在传统的内镜逆行胰胆管造影(ERCP)中,患者在深度镇静下俯卧或半俯卧,并保持自主通气。镇静剂引起的呼吸抑制和无保护的气道损害了患者的安全。胃喉管(G-LT)是一种新型的可重复使用的声门上气道装置,具有两个单独的端口,用于内窥镜检查和通气。本研究试图评估G-LT的表现特征。方法:140名接受ERCP的患者被纳入并随机分组。在G组中,患者采用G-LT进行ERCP,而S组患者采用常规ERCP。G-LT插入次数、食道可视化时间、生命参数、丙泊酚用量、内镜医生和麻醉师的满意度评分、达到改良Aldrete评分的时间 ≥ 9例,并记录并发症。结果:两组患者的人口学参数相似,手术完成率均为100%。G-LT组显示食管可视化时间缩短(4.71 ± 1.687 s与7.37 ± 1.515 s) 丙泊酚消耗量增加(423.14 ± 106.982 mg vs 178.00 ± 100.125 mg)。G组表现出更好的内镜操作性和较小的血液动力学变异性。G-LT组的喉咙痛、吞咽困难和粘膜损伤发生率较高。结论:G-LT以较高的丙泊酚消耗量、喉咙痛、吞咽困难和粘膜损伤为代价,提供了较少的术中血液动力学变化、更快的食管可视化和更好的范围可操作性。试验注册:印度临床试验注册中心CTRI/2021/06/034212(注册日期:2021年6月14日)。
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来源期刊
Expert Review of Medical Devices
Expert Review of Medical Devices 医学-工程:生物医学
CiteScore
5.90
自引率
3.20%
发文量
69
审稿时长
6-12 weeks
期刊介绍: The journal serves the device research community by providing a comprehensive body of high-quality information from leading experts, all subject to rigorous peer review. The Expert Review format is specially structured to optimize the value of the information to reader. Comprehensive coverage by each author in a key area of research or clinical practice is augmented by the following sections: Expert commentary - a personal view on the most effective or promising strategies Five-year view - a clear perspective of future prospects within a realistic timescale Key issues - an executive summary cutting to the author''s most critical points In addition to the Review program, each issue also features Medical Device Profiles - objective assessments of specific devices in development or clinical use to help inform clinical practice. There are also Perspectives - overviews highlighting areas of current debate and controversy, together with reports from the conference scene and invited Editorials.
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