胃内气球不良事件:一个全面的MAUDE数据库审查
Islam Mohamed1, Jagadish Koyi2, Husam Abu Suilik3
1Department of Gastroenterology and Hepatology, University of Missouri, Columbia, Missouri, USA.
Proceedings (Baylor University. Medical Center)
|December 23, 2024
概括
体重减轻的胃内气球可能会失败,通胀和破裂是常见的问题. 患者的并发症,如植入物失败,疼痛和吐,需要对这些内镜减肥器件进行持续的安全监测.
科学领域:
- 腹腔内镜检查 腹腔内镜检查 腹腔内镜检查
- 医疗器械安全 医疗器械安全
- 肥胖管理 肥胖管理
背景情况:
- 内镜减肥干预为30-40公斤/米2的BMI患者提供了传统手术的替代方案.
- 有限的现实数据存在于设备相关的并发症和胃内气球的故障.
- 这项研究通过调查报告给美国食品和药物管理局的机械故障和不良事件来弥补这一差距.
研究的目的:
- 为了分析与装置相关的胃内气球的机械故障.
- 在使用这些设备的患者中识别常见的并发症和不良事件.
- 根据现实世界的数据,评估各种胃内气球的安全性.
主要方法:
- 制造商和用户设施设备体验 (MAUDE) 数据库的回顾性分析.
- 包括2017年7月至2023年10月的胃内气球的设备相关事件和患者结果.
- 使用SPSS进行统计分析,以评估报告的事件和气球类型的关联.
主要成果:
- 总共审查了1393个病例,确定了1758个设备故障和1760个患者并发症.
- 最常见的设备故障是通气问题 (25.31%) 和气球泄漏或破裂 (21.90%).
- 奥贝拉气球与患者并发症的相关性最高,包括植入物失败 (24.30%),腹痛 (21.92%) 和吐 (21.26%).
结论:
- 这些发现强调了对胃内气球安全的持续监测的必要性.
- 严格的监测和加强的安全协议对于管理与设备相关的风险至关重要.
- 现实世界数据分析对于改善内镜减肥干预患者的治疗结果至关重要.
相关概念视频
01:25Peptic Ulcer Disease V: Surgical Management and Nursing Care
228
Surgical management and nursing care are crucial in treating Peptic Ulcer Disease (PUD). Here is an organized and enhanced overview of the surgical interventions and the associated nursing care for PUD:
Surgical Interventions for Peptic Ulcer Disease
Surgical Interventions for Peptic Ulcer Disease
228
01:29Endoscopic Procedures I: Esophagogastroduodenoscopy
66
An Esophagogastroduodenoscopy (EGD) is a diagnostic procedure in which an endoscopist uses a flexible, lighted endoscope to visualize the upper gastrointestinal (GI) tract. The procedure includes visualizing the oropharynx, esophagus, stomach, and the first part of the small intestine, the duodenum.
During an EGD, the endoscope can be used to:
During an EGD, the endoscope can be used to:
66
01:28Peptic Ulcer Disease III: Clinical Manifestations and Diagnostic Studies
88
Peptic ulcer disease (PUD) presents with diverse symptoms depending on the location and severity of the ulcer. Clinical manifestations of peptic ulcer include dull pain and a burning sensation in the mid-epigastric region.
Few clinical manifestations differentiate gastric ulcers from duodenal ulcers. Distinctions in the location, timing, and pain relief are crucial for healthcare providers in differentiating between gastric and duodenal ulcers during clinical assessments.
Few clinical manifestations differentiate gastric ulcers from duodenal ulcers. Distinctions in the location, timing, and pain relief are crucial for healthcare providers in differentiating between gastric and duodenal ulcers during clinical assessments.
88
01:17Assessment of the Gastrointestinal System I: Subjective Data
144
Assessing the gastrointestinal (GI) system is a complex process that begins with collecting subjective data. This data, collected through patient interviews, provides crucial insights into the patient's health history, perception patterns, and lifestyle habits, all contributing significantly to GI health.
Health History
The initial step in assessing the GI system is obtaining a comprehensive health history. This includes inquiring about the patient's history or presence of problems...
Health History
The initial step in assessing the GI system is obtaining a comprehensive health history. This includes inquiring about the patient's history or presence of problems...
144