鼻胃管与口胃管置入对重症患者呼吸机相关性肺炎发生率的影响：法国16个重症监护病房的一项整群随机交叉试验研究方案（SONG试验）

Effect of nasogastric versus orogastric tube placement on ventilator-associated pneumonia incidence in critically ill patients: a study protocol for a cluster randomised crossover trial in 16 intensive care units in France (SONG trial).

作者信息

Saletes Josselin, Guitton Christophe, Valleroy Julie, Guillarme Severine, Haubertin Carole, Paris Gregory, Muller Lucie, Rousseau Cécile, Gamon Prescilla, L'Hotellier Sylvie, Forel Jean-Marie, Roussel Catherine, Garin Antoine, Morand Célina, Maury Eric, Mangeard Nathanael, Menard Laetitia, Arnaud Pierre-Yves, Lejeune Aurélie, Rouanet Eglantine, Callahan Jean-Christophe

机构信息

Service de Réanimation Polyvalente, Centre Hospitalier du Mans, Le Mans, France.

Unité de Soins Longue Durée, Centre Hospitalier du Mans, Le Mans, France.

出版信息

BMJ Open. 2025 Sep 8;15(9):e099840. doi: 10.1136/bmjopen-2025-099840.

DOI:10.1136/bmjopen-2025-099840

PMID:40921641

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12421159/

Abstract

INTRODUCTION

Patients in intensive care units (ICUs) frequently require mechanical ventilation, with approximately half needing invasive ventilation through an orotracheal tube. For these patients, gastric tube (GT) insertion is routinely performed to administer nutrition and medications or to drain gastric contents. The insertion route (oral or nasal) may affect the incidence of ventilator-associated pneumonia (VAP), a significant ICU care complication. This study aims to compare the impact of oral versus nasal GT insertion on the incidence of VAP in intubated ICU patients.

METHODS AND ANALYSIS

The SONG trial (NCT05915663) is a multicentre, open-label, two-period, two-intervention, cluster randomised crossover superiority trial. 16 French ICUs will participate. ICUs will be randomised to periods of nasogastric or orogastric tube placement. The trial includes a practice standardisation period, followed by two 12-month inclusion periods separated by a monitoring and washout period. The primary endpoint is the incidence rate of VAP at day 28, confirmed by three independent physicians. Secondary endpoints include the ease of GT insertion, measured by the number of attempts.

ETHICS AND DISSEMINATION

This study received approval from a central ethical review board on 12 April 2024 (CPP Sud-est VI, registration number 23.00943.000175). Patients are included after informed consent or, when not possible, from next of kin. If none are available, the investigator will proceed with emergency inclusion, following French law. When consent is initially obtained from the next of kin or through emergency inclusion, the investigator will seek consent from the patient as soon as possible. Data will be anonymised and patient confidentiality maintained. Results will be published in peer-reviewed journals and presented at scientific meetings.

TRIAL REGISTRATION NUMBER

NCT05915663.

摘要

引言

重症监护病房（ICU）的患者经常需要机械通气，其中约一半患者需要通过口气管插管进行有创通气。对于这些患者，常规进行胃管（GT）插入以给予营养和药物或引流胃内容物。插入途径（经口或经鼻）可能会影响呼吸机相关性肺炎（VAP）的发生率，这是一种严重的ICU护理并发症。本研究旨在比较经口与经鼻插入GT对插管ICU患者VAP发生率的影响。

方法与分析

SONG试验（NCT05915663）是一项多中心、开放标签、两阶段、两种干预、整群随机交叉优势试验。16家法国ICU将参与。ICU将被随机分为鼻胃管或口胃管放置阶段。该试验包括一个实践标准化阶段，随后是两个12个月的纳入期，中间有一个监测和洗脱期。主要终点是第28天VAP的发生率，由三名独立医生确认。次要终点包括通过尝试次数衡量的GT插入的难易程度。

伦理与传播

本研究于2024年4月12日获得中央伦理审查委员会的批准（CPP Sud-est VI，注册号23.00943.000175）。患者在获得知情同意后纳入，或在无法获得知情同意时，由近亲纳入。如果无人可用，研究者将根据法国法律进行紧急纳入。当最初从近亲处获得同意或通过紧急纳入时，研究者将尽快寻求患者的同意。数据将进行匿名化处理并保持患者的保密性。结果将发表在同行评审期刊上，并在科学会议上展示。