Validating nasogastric tube placement with pH testing: A randomized controlled trial protocol

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Contemporary Clinical Trials Communications Pub Date : 2024-05-22 DOI:10.1016/j.conctc.2024.101312
Stefano Mancin , Pietro Stallone , Valeria Siro , Manuela Pastore , Daniela Cattani , Diego Lopane , Alessandra Dacomi , Francesco Carlo Tartaglia , Alessandro Bellone , Francesca Serazzi , Georges Laffoucriere , Chiara Coldani , Giuseppina Tomaiuolo , Beatrice Mazzoleni
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Abstract

Background

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.

Study objective

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.

Materials and methods

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.

Ethical considerations

authorization no. 3624, Territorial Ethical Committee Lombardy 5, October 20, 2023.

Implications and perspectives

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.

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通过 pH 值测试验证鼻胃管放置位置:随机对照试验方案
背景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、低风险地提供营养。然而,通过胸片确认放置位置除了会延误营养治疗的开始,还会使患者受到辐射。本研究的主要目的是评估用于营养目的的 NGT 的高效置管情况,通过使用电子 pH 计进行 pH 值测试,优化对正确插入 NGT 的评估。此外,该研究还旨在评估患者对干预的耐受性。材料和方法这项单中心 RCT 将包括 150 名 EN 候选患者,分为三组。每组将使用不同的 NGT,通过 pH 值测试和胸片检查评估放置的安全性。将对耐受性、与 NGT 置入相关的并发症和成本进行评估,并通过安全电子数据库匿名收集数据。本方案引入了先进的 NGT 和电子 pH 计等创新技术,旨在优化肠内营养管理。这项 RCT 的重点是取代 X 射线作为验证 NGT 置位的主要方法,从而减少成本、时间和患者暴露于辐射的机会。数据分析可为管理使用改变 pH 值药物的患者提供见解。采用创新技术有可能减少错误,提高经济效益和流程的可持续性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Contemporary Clinical Trials Communications
Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology
CiteScore
2.70
自引率
6.70%
发文量
146
审稿时长
20 weeks
期刊介绍: Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.
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