Incidence and Complications of Post-extubation and Post-tracheostomy Dysphagia in Adult Patients in the Critical Care Unit
NCT Number: NCT06583824
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Respiratory Complications|Pneumonia|Quality of Lifte|Death|Swallowing Disorder.Other Specified
Sponsor: Complejo Hospitalario Universitario de Albacete
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 414
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-10
Completion Date: 2026-09-30

Summary:
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 \&amp;amp;lt; 0.05, 95% CI; Bivariate analysis: Checking group homogeneity and hypothesis testing: Chi-square, Student\&amp;amp;#39;s t-test, U-Mann-Whitney, ANOVA, or Kruskal-Wallis.

Primary Outcome Measures: Respiratory Complications, 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 \&gt; 38oC, leukocyte count \&gt; 12,000/mm3 or leukocytopenia \&lt; 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., This outcome variable may appear from the completion of the mV-VST until the end of participation 90 days after hospital discharge.