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

NCT06583824 | Not Yet Recruiting DMC

• 1 other identifier: Chospab
• Study Type: observational
• Target: 414
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

dysphagia; tracheostomy; aspiration; malnutrition; critical care; mechanical ventilation; pneumonia

Outcome Measures

Primary Outcomes (1)

• 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 \> 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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients admitted to the multidisciplinary ICU at CHUA who require intubation or tracheostomy during their stay. CHUA is a tertiary-level hospital with approximately 700 beds, and it is part of the Integrated Healthcare Management of Albacete under the Health Service of Castilla-La Mancha (SESCAM). The multidisciplinary Intensive Care Unit is located on the second floor, central area, of the General Hospital. It is a general (multidisciplinary) unit that manages all critical pathologies (along with other critical care units in the Hospital Complex) except for pediatric cases. The multidisciplinary ICU currently has 18 functional beds, and the majority of admissions are due to medical conditions.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Complejo Hospitalario Universitario de Albacete: lead

Related Publications (7)

• Macht M, Wimbish T, Bodine C, Moss M. ICU-acquired swallowing disorders. Crit Care Med. 2013 Oct;41(10):2396-405. doi: 10.1097/CCM.0b013e31829caf33.

  PMID: 23939361 BACKGROUND

• McInytre M, Doeltgen S, Shao C, Chimunda T. The incidence and clinical outcomes of postextubation dysphagia in a regional critical care setting. Aust Crit Care. 2022 Mar;35(2):107-112. doi: 10.1016/j.aucc.2021.03.008. Epub 2021 May 24.

  PMID: 34034939 BACKGROUND

• Schefold JC, Berger D, Zurcher P, Lensch M, Perren A, Jakob SM, Parviainen I, Takala J. Dysphagia in Mechanically Ventilated ICU Patients (DYnAMICS): A Prospective Observational Trial. Crit Care Med. 2017 Dec;45(12):2061-2069. doi: 10.1097/CCM.0000000000002765.

  PMID: 29023260 BACKGROUND

• Martinez de Lagran Zurbano I, Laguna LB, Soria CV, Guisasola CP, Marcos-Neira P. Utility of the modified Volume-Viscosity Swallow Test for bedside screening of dysphagia in critically ill patients. Clin Nutr ESPEN. 2023 Feb;53:214-223. doi: 10.1016/j.clnesp.2022.12.021. Epub 2022 Dec 23.

  PMID: 36657916 BACKGROUND

• Zaldibar-Barinaga MB, Miranda-Artieda M, Zaldibar-Barinaga A, Pinedo-Otaola S, Erazo-Presser P, Tejada-Ezquerro P. Versión española del Swallowing Quality of Life Questionnaire: fase inicial de adaptación transcultural. Rehabilitación. 2013;47(3):136-40.

  BACKGROUND

• McIntyre M, Doeltgen S, Dalton N, Koppa M, Chimunda T. Post-extubation dysphagia incidence in critically ill patients: A systematic review and meta-analysis. Aust Crit Care. 2021 Jan;34(1):67-75. doi: 10.1016/j.aucc.2020.05.008. Epub 2020 Jul 29.

  PMID: 32739246 BACKGROUND

• Skoretz SA, Flowers HL, Martino R. The incidence of dysphagia following endotracheal intubation: a systematic review. Chest. 2010 Mar;137(3):665-73. doi: 10.1378/chest.09-1823.

  PMID: 20202948 BACKGROUND

MeSH Terms

Conditions

Pneumonia; Death; Deglutition Disorders; Malnutrition

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Nutrition Disorders; Nutritional and Metabolic Diseases

Central Study Contacts

Francisca CALERO YAÑEZ, grado en enfermeria

CONTACT

34967597100; fcalero@sescam.jccm.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Graduada en Enfermeria

Study Record Dates

• First Submitted: September 2, 2024
• First Posted: September 4, 2024
• Study Start: September 10, 2024
• Primary Completion: February 15, 2025
• Study Completion (Estimated): September 30, 2026
• Last Updated: September 4, 2024

Record last verified: 2024-09