Mancin Stefano, Stallone Pietro, Siro Valeria, Pastore Manuela, Cattani Daniela, Lopane Diego, Dacomi Alessandra, Tartaglia Francesco Carlo, Bellone Alessandro, Serazzi Francesca, Laffoucriere Georges, Coldani Chiara, Tomaiuolo Giuseppina, Mazzoleni Beatrice
Department of Biomedicine and Prevention, University of Rome "Tor Vergata", Rome, Italy.
Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy.
Contemp Clin Trials Commun. 2024 May 22;39:101312. doi: 10.1016/j.conctc.2024.101312. eCollection 2024 Jun.
Enteral nutrition (EN) is preferred when oral feeding is not possible. The use of the Nasogastric Tube (NGT) ensures rapid and low-risk nutrient administration. However, confirming the placement through chest radiography, besides delaying the initiation of nutritional therapy, exposes patients to radiation. The pH test of gastric aspirate provides a quicker check for NGT placement, but its reliability is compromised by challenges related to aspirating gastric secretions.
The main objective of this study is to assess the high-performance placement of NGTs for nutritional purposes, optimizing the evaluation of correct insertion through pH testing using an electronic pH meter. Additionally, the study aims to evaluate patient tolerance to the intervention.
This single-center RCT will include 150 EN candidate patients divided into three groups. Each group will use distinct NGTs, evaluating placement through pH testing and chest radiography for safety. Tolerance, complications related to NGT placement, and costs will be assessed, with data collected anonymously through a secure electronic database.
authorization no. 3624, Territorial Ethical Committee Lombardy 5, October 20, 2023.
This protocol introduces innovative technologies, such as advanced NGTs and an electronic pH meter, aiming to optimize enteral nutrition management. This RCT focuses on replacing X-rays as the primary method for verifying NGT placement, thereby reducing costs, time, and patient exposure to radiation. Data analysis may provide insights into managing patients on pH-altering medication. Implementing innovative technologies has the potential to reduce errors and improve economic efficiency and process sustainability.
当无法进行口服喂养时,肠内营养(EN)是首选。使用鼻胃管(NGT)可确保快速且低风险地给予营养。然而,通过胸部X光检查确认鼻胃管位置,除了会延迟营养治疗的开始外,还会使患者暴露于辐射中。胃吸出物的pH值测试能更快地检查鼻胃管位置,但由于在抽吸胃分泌物方面存在挑战,其可靠性受到影响。
本研究的主要目的是评估用于营养目的的鼻胃管的高效放置,通过使用电子pH计进行pH测试来优化对正确插入的评估。此外,该研究旨在评估患者对干预措施的耐受性。
这项单中心随机对照试验将纳入150名符合肠内营养条件的患者,分为三组。每组将使用不同的鼻胃管,通过pH测试和胸部X光检查评估放置情况以确保安全。将评估耐受性、与鼻胃管放置相关的并发症及成本,通过安全的电子数据库匿名收集数据。
授权编号3624,伦巴第地区伦理委员会,2023年10月20日。
本方案引入了先进的鼻胃管和电子pH计等创新技术,旨在优化肠内营养管理。这项随机对照试验专注于取代X光作为验证鼻胃管位置的主要方法,从而降低成本、节省时间并减少患者的辐射暴露。数据分析可能为管理正在服用改变pH值药物的患者提供见解。实施创新技术有可能减少错误并提高经济效率和流程可持续性。