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老年病科老年患者吞咽困难相关风险的筛查和预防程序的可行性:DYSPHAGING 预试验研究方案。

Feasibility of a screening and prevention procedure for risks associated with dysphagia in older patients in geriatric units: the DYSPHAGING pilot study protocol.

机构信息

Institut du Vieillissement, Hospices Civils de Lyon, Lyon, Auvergne-Rhône-Alpes, France.

Centre de Recherche Clinique Vieillissement, Cerveau, Fragilité, Hôpital des Charpennes, Hospices Civils de Lyon, Villeurbanne, Auvergne-Rhône-Alpes, France.

出版信息

BMJ Open. 2024 Apr 19;14(4):e081333. doi: 10.1136/bmjopen-2023-081333.

DOI:10.1136/bmjopen-2023-081333
PMID:38642998
原文链接:
https://pmc.ncbi.nlm.nih.gov/articles/PMC11033636/
Abstract

BACKGROUND

Dysphagia, particularly sarcopenic dysphagia, is frequent in frail older patients. Sarcopenic dysphagia is a swallowing disorder caused by sarcopenia, corresponding to a loss of muscle mass and strength. It frequently leads to inhalation and to the decrease of food intake, leading the patient to enter a vicious circle of chronic malnutrition and frailty. The awareness of the major health impacts of sarcopenic dysphagia is recent, explaining a low rate of screening in the population at risk. In this context, methods of prevention, evaluation and intervention of sarcopenic dysphagia adapted to the most at-risk population are necessary.

METHODS

The DYSPHAGING (dysphagia & aging) pilot study is a prospective, multicentre, non-comparative study aiming to estimate the feasibility of an intervention on allied health professionals using the DYSPHAGING educational sheet designed to implement a two-step procedure 'screen-prevent' to mitigate swallowing disorders related to sarcopenic dysphagia. After obtaining oral consent, patients are screened using Eating Assessment Tool-10 Score. In case of a score≥2, procedures including positional manoeuvres during mealtimes, food and texture adaptation should be implemented. The primary endpoint of the study is the feasibility of this two-step procedure (screening-prevention measures) in the first 3 days after patient's consent.The study will include 102 patients, with an expected 10% rate of non-analysable patients. Participants will be recruited from acute geriatric wards, rehabilitation centres and long-term care units, with the hypothesis to reach a feasibility rate of 50% and reject a rate lower than 35%.

ETHICS AND DISSEMINATION

The study protocol was approved according to French legislation (CPP Ile-de-France VII) on 15 February 2023. The results of the primary and secondary objectives will be published in peer-reviewed journals.

TRIAL REGISTRATION NUMBER

NCT05734586.

摘要

背景

衰弱老年人常发生吞咽困难,尤其是肌少症性吞咽困难。肌少症性吞咽困难是一种由肌肉减少症引起的吞咽障碍,表现为肌肉质量和力量下降。它常导致吸入,减少食物摄入,使患者陷入慢性营养不良和虚弱的恶性循环。肌少症性吞咽困难对健康的重大影响最近才被认识到,这解释了高危人群筛查率低的原因。在这种情况下,需要针对高危人群制定预防、评估和干预肌少症性吞咽困难的方法。

方法

DYSPHAGING(吞咽困难与衰老)试点研究是一项前瞻性、多中心、非对照研究,旨在评估使用 DYSPHAGING 教育表对医疗保健专业人员进行干预的可行性,该教育表旨在实施两步程序“筛查-预防”,以减轻与肌少症性吞咽困难相关的吞咽障碍。在获得口头同意后,患者使用 Eating Assessment Tool-10 评分进行筛查。如果评分≥2,应实施体位管理、饮食和质地调整等措施。该研究的主要终点是在患者同意后的头 3 天内,该两步程序(筛查-预防措施)的可行性。该研究将纳入 102 例患者,预计有 10%的患者无法进行分析。参与者将从急性老年病房、康复中心和长期护理机构招募,假设达到 50%的可行性率,并拒绝低于 35%的可行性率。

伦理与传播

该研究方案于 2023 年 2 月 15 日根据法国立法(法兰西岛七区 CPP)获得批准。主要和次要目标的结果将在同行评议期刊上发表。

试验注册号

NCT05734586。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/80f4/11033636/778d58ea7c02/bmjopen-2023-081333f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/80f4/11033636/b2aeca7fb087/bmjopen-2023-081333f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/80f4/11033636/778d58ea7c02/bmjopen-2023-081333f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/80f4/11033636/b2aeca7fb087/bmjopen-2023-081333f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/80f4/11033636/778d58ea7c02/bmjopen-2023-081333f02.jpg

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