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临床试验/NCT06583824
NCT06583824尚未招募不适用

Incidence and Complications Associated With Acquired Swallowing Disorder in the Intensive Care Unit in Extubated or Tracheotomized Patients: A Cohort Study

Complejo Hospitalario Universitario de Albacete0 个研究点目标入组 414 人开始时间: 2024年9月10日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
414
主要终点
Respiratory Complications

研究概览

简要总结

Acquired Swallowing Disorder in ICU (ICU-ASD), also known as postextubation dysphagia, is a multicausal problem experienced by survivors in intensive care units (ICUs) when the efficiency, safety of swallowing, or both are compromised. These alterations can lead to an increased risk of aspiration, respiratory complications, and malnutrition, potentially resulting in prolonged hospitalization, reduced quality of life, poorer clinical outcomes, and even death.

Despite the clinical and social significance of this disorder, there is limited research addressing it. Existing studies primarily focus on incidence and associated factors, with scant attention to the occurrence of complications, and there is a lack of assessment of the quality of life of these patients. In our context, healthcare professionals are increasingly recognizing the importance of this issue, although the real incidence of ICU-ASD, as well as the frequency of respiratory and nutritional complications, remains unknown. Furthermore, the quality of life of patients with this disorder has not been evaluated thus far.

Objectives:Primary: To analyze the occurrence of respiratory and nutritional complications associated with ICU-ASD in patients intubated for ≥48 hours or tracheotomized in the Intensive Care Unit of the University Hospital Complex of Albacete (ICU CHUA) and identify potential factors related to their occurrence.

Specific: To determine the incidence of ICU-ASD in the polyvalent ICU CHUA, assess the frequency of respiratory complications, evaluate nutritional status, assess quality of life, and determine the mortality of study participants.

Material and Method: Prospective observational cohort study. Setting: Polyvalent ICU CHUA. Participants: Intubated patients for ≥48 hours or tracheotomized, with signed consent. Sampling: Consecutive. Sample size: 414 participants. Demographic/clinical variables. Outcome variables: Occurrence of respiratory complications, nutritional status, quality of life. Instruments: Modified Volume-Viscosity Swallowing Test (mV-VST), Swallowing Quality of Life Questionnaire (SWAL-QoL). Dysphagia detection will occur 24 hours post-extubation and/or 4 days after tracheotomy. Follow-up during hospitalization and post-ICU discharge until the outpatient consultation. Statistical analysis: Absolute and relative frequencies, measures of central tendency and dispersion, significance level of p < 0.05, 95% CI; Bivariate analysis: Checking group homogeneity and hypothesis testing: Chi-square, Student's t-test, U-Mann-Whitney, ANOVA, or Kruskal-Wallis.

详细描述

Hypothesis: Patients with ICU-Acquired Swallowing Disorder (ICU-ASD) have a higher frequency of respiratory complications and poorer nutritional status compared to patients without dysphagia.

Objectives:

Primary Objective: To analyze the occurrence of respiratory and nutritional complications associated with ICU-Acquired Swallowing Disorder (ICU-ASD) in patients intubated for more than 48 hours or tracheostomized in the multidisciplinary ICU at CHUA, and to explore potential factors related to their occurrence.

Secondary Objectives:

To determine the incidence of ICU-ASD in the multidisciplinary ICU at CHUA. To determine the frequency of respiratory complications in post-extubated and tracheostomized patients in the multidisciplinary ICU at CHUA.

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged ≥ 18 years, requiring intubation for ≥ 48 hours and/or subsequent tracheostomy, with an adequate level of consciousness to perform the dysphagia diagnostic test, and who have signed the consent form.

排除标准

  • Previous tracheostomy, prior diagnosis of dysphagia, neurodegenerative disease, or a history of stroke (CVA).

结局指标

主要结局

Respiratory Complications

时间窗: This outcome variable may appear from the completion of the mV-VST until the end of participation 90 days after hospital discharge.

Pneumonia: when a new pulmonary infiltrate or progression appears on the chest x-ray, or cavitation or consolidation, associated with at least 2 of the following criteria: temperature \> 38oC, leukocyte count \> 12,000/mm3 or leukocytopenia \< 4,000/mm3, purulent orotracheal secretion or change in the characteristic of sputum, increased secretions and need for greater suction, new respiratory sounds or rales, worsening oxygenation. tracheobronchitis: clinical syndrome similar to pneumonia that must meet at least 2 of the aforementioned criteria, without radiographic infiltrate present.

次要结局

未报告次要终点

研究者

发起方
Complejo Hospitalario Universitario de Albacete
申办方类型
Other
责任方
Principal Investigator
主要研究者

Francisca Calero Yañez

Graduada en Enfermeria

Complejo Hospitalario Universitario de Albacete

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