Expert review of medical devices · 2023
Outcomes and evaluation of endoscopic retrograde cholangiopancreatography via Gastro-Laryngeal Tube in adult patients: a prospective randomised control study.
Рандомизированное исследованиеСтатьяНазвание и аннотация: Перевод в очереди
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Dengre Anshika, Haldar Rudrashish, Kannaujia Ashish Kumar, Singh Nidhi, Mohindra Samir, Mishra Prabhaker
Аннотация
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).
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).