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
{"title":"通过 pH 值测试验证鼻胃管放置位置：随机对照试验方案","authors":"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","doi":"10.1016/j.conctc.2024.101312","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><p>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.</p></div><div><h3>Study objective</h3><p>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.</p></div><div><h3>Materials and methods</h3><p>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.</p></div><div><h3>Ethical considerations</h3><p>authorization no. 3624, Territorial Ethical Committee Lombardy 5, October 20, 2023.</p></div><div><h3>Implications and perspectives</h3><p>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.</p></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":null,"pages":null},"PeriodicalIF":1.4000,"publicationDate":"2024-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2451865424000590/pdfft?md5=2ec2ac4371f7fe5730bff70a37825821&pid=1-s2.0-S2451865424000590-main.pdf","citationCount":"0","resultStr":"{\"title\":\"Validating nasogastric tube placement with pH testing: A randomized controlled trial protocol\",\"authors\":\"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\",\"doi\":\"10.1016/j.conctc.2024.101312\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><p>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.</p></div><div><h3>Study objective</h3><p>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.</p></div><div><h3>Materials and methods</h3><p>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.</p></div><div><h3>Ethical considerations</h3><p>authorization no. 3624, Territorial Ethical Committee Lombardy 5, October 20, 2023.</p></div><div><h3>Implications and perspectives</h3><p>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. 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Validating nasogastric tube placement with pH testing: A randomized controlled trial protocol
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.
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.
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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