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Incidence and Complications of Post-extubation and Post-tracheostomy Dysphagia in Adult Patients in the Critical Care Unit

NCT06583824 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 414

Last updated 2024-09-04

No results posted yet for this study

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 \< 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.

Conditions

  • Respiratory Complications
  • Pneumonia
  • Quality of Lifte
  • Death
  • Swallowing Disorder.Other Specified

Sponsors & Collaborators

  • Complejo Hospitalario Universitario de Albacete

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-10
Primary Completion
2025-02-15
Completion
2026-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06583824 on ClinicalTrials.gov