Contemporary Clinical Trials Communications (Jun 2024)

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

  • 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

Journal volume & issue
Vol. 39
p. 101312

Abstract

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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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