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临床试验/NCT04346212
NCT04346212已完成不适用

Oropharyngeal Dysphagia and Malnutrition in Patients Infected by SARS-CoV-2: Prevalence and Needs of Compensatory Treatment and Follow up in Patients Admitted by COVID-19 at the Consorci Sanitari Del Maresme

Hospital de Mataró1 个研究点 分布在 1 个国家目标入组 605 人开始时间: 2020年4月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
605
试验地点
1
主要终点
Changes in the prevalence of oropharyngeal dysphagia

研究概览

简要总结

Background: Oropharyngeal dysphagia (OD) is a common complication in/post ICU patients that have been with intubation/mechanical ventilation or with tracheotomies or NG tubes, in patients with acute respiratory infection/pneumonia/respiratory insufficiency with a severe disease needing high concentration of oxygen or noninvasive mechanical ventilation and also in patients discharged from acute hospitals to rehabilitation centers, nursing homes or other facilities. All these situations are common for COVID-19 patients that are currently filling our hospitals due to the pandemic expansion of SARS-CoV-2. OD is associated to prolonged hospitalization, dehydration and severe nutritional and respiratory complications -aspiration pneumonia-, hospital readmissions and mortality. Aim: to assess the prevalence of OD and nutritional risk in these patients and to know their needs of compensatory treatment following the application of an early intervention, and to assess whether OD and malnutrition are indicators of poor prognosis for COVID-19 patients. Methods: prospective study in which we will use the volume-viscosity swallowing test (V-VST) to assess the prevalence of OD, and NRS2002 to assess the nutritional risk in admitted patients with confirmed COVID-19 at the Consorci Sanitari del Maresme, Catalonia, Spain. We will register also results of the EAT-10, nutritional status, the needs of compensatory treatments of these patients following an early intervention with fluid and nutritional adaptation and use of nutritional supplements. We will also collect other clinical variables from medical history of the patient related to hospitalization and we will follow the clinical complications and nutritional status at 3 and 6 months follow up.

详细描述

Design: 1) prospective study in SARS-CoV-2 infected patients admitted to the CSdM more than 48h with 2 follow-up points at 3/6 months after discharge.

  1. comparative study between the 3 first waves of the pandemic in the acute phase.

Aims:

1.1)To assess the prevalence of OD, nutritional risk, the needs of compensatory treatment and complications at 3/6 month follow up of patients admitted by COVID-19 in Hospital de Mataró, Hospital St. Jaume and the medicalized Atenea Hotel, Mataró (Barcelona), Spain.

1.2)To validate an early intervention including fluid thickening and nutritional support.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Infected patients (COVID-19 + by PCR or according to physician's criteria in the medical report of the patient at discharge) admitted to the CSdM more than 48 h.
  • Patients able to be explored regarding OD and nutritional status according to their physician's criteria (fully awake patients in a stable respiratory situation and optimal PaO2/FiO2).

排除标准

  • Uncontrolled risk of infection for healthcare professionals (HCP) (according to the safety considerations stated below).

结局指标

主要结局

Changes in the prevalence of oropharyngeal dysphagia

时间窗: From April 2020 to September 2021. And at 3 and 6 months follow-up (1st wave).

Changes in the prevalence of oropharyngeal dysphagia according to a clinical assessment tool, the Volume-Viscosity Swallowing Test (V-VST).

次要结局

  • Changes in the nutritonal status of study patient's.(From April 2020 to September 2021. And at 3 and 6 months follow-up (1st wave).)
  • Changes in the needs of compensatory treatments in those patients with oropharyngeal dysphagia (fluid adaptation).(From April 2020 to September 2021. And at 3 and 6 months follow-up (1st wave).)
  • Changes in the clinical complications at 3 and 6 months follow up from patient's medical history (incidence of readmissions).(3 and 6 months from inclusion.)
  • Changes in the needs of compensatory treatments in those patients with oropharyngeal dysphagia (nutritional adaptation).(From April 2020 to September 2021. And at 3 and 6 months follow-up (1st wave).)
  • Changes in the clinical complications at 3 and 6 months follow up from patient's medical history (respiratory complications).(3 and 6 months from inclusion.)
  • Changes in the clinical complications at 3 and 6 months follow up from patient's medical history (mortality).(3 and 6 months from inclusion.)
  • Changes in the swallowing screening(From April 2020 to September 2021. And at 3 and 6 months follow-up (1st wave).)
  • Changes in the swallowing status(From April 2020 to September 2021. And at 3 and 6 months follow-up (1st wave).)
  • Changes in the clinical complications at 3 and 6 months follow up from patient's medical history (number of visits to emergency department).(3 and 6 months from inclusion.)
  • Changes in the clinical complications at 3 and 6 months follow up from patient's medical history (prevalence of readmissions).(3 and 6 months from inclusion.)
  • Changes in the clinical complications at 3 and 6 months follow up from patient's medical history (percentage of visits to emergency department).(3 and 6 months from inclusion.)

研究者

发起方
Hospital de Mataró
申办方类型
Other
责任方
Principal Investigator
主要研究者

Pere Clave

Director of Research and Academic Development at CSdM

Hospital de Mataró

研究点 (1)

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