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

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.

To assess the nutritional status of post-extubated and tracheostomized patients in the multidisciplinary ICU at CHUA.

To evaluate the quality of life with dysphagia in patients who developed ICU-ASD after hospital discharge.

To determine the mortality rate of post-extubated and tracheostomized patients in the ICU at CHUA.

SAMPLE SIZE: Since there is no existing data on complications caused by dysphagia in our unit, we have considered the study by McIntyre et al. (2022), which shows an incidence of pneumonia of 21% in patients with ICU-ASD and 9% in extubated patients without dysphagia (OR=2.51; 95% CI 1.27-4.95). Based on these premises, the sample size was calculated using the Epiinfo® program, estimating a 95% confidence interval (CI), 80% power, and a 1:1 group ratio. We obtain a sample of 360 participants, adding 15% for potential losses, which means an additional 54 patients. The final sample size to be achieved is 414 participants. Participants will be selected through consecutive sampling, meeting inclusion criteria, and always with signed consent after verbal information and delivery of the information sheet. According to statistical data from the CHUA ICU from previous years, achieving this sample will likely take two years.

RECRUITMENT PERIOD: September 2024-September 2026 (2 years) STUDY COMPLETION: Completion of the study until the end of follow-up, death, or withdrawal of informed consent.

VARIABLES AND MEASUREMENT INSTRUMENTS:

Age (difference between date of birth and admission date). Collected from the medical record.

Sex (male/female). As recorded in the medical record. Comorbidities (personal history of disease). Collected from the medical record. Categorized admission diagnosis: cardiovascular, respiratory, gastrointestinal, neurological, trauma, metabolic, hematological, urological, intoxications, and others. These may be later analyzed as two groups: NEUROCRITICAL/NON-NEUROCRITICAL.

Presence of NG tube and number of days. Number and type (Levin®, Flekka®, nasojejunal). Collected from the patient\'s daily ICU chart.

Endotracheal tube used: number and type (subglottic/non-subglottic). Collected from the vital signs chart.

Tracheostomy: technique used for insertion (PERCUTANEOUS/SURGICAL), cannula number, and type (with cuff/without cuff). Collected from the patient\'s vital signs chart.

Days of pre-ICU admission (ICU admission date - hospital admission date). Collected from the medical record.

Days of ICU admission (date of transfer to the ward or death - ICU admission date). Collected from the medical record.

Days of post-ICU admission (from transfer to the ward until discharge). Collected from the medical record.

Total hospital stay (day of discharge - day of admission). Collected from the medical record.

Days with invasive mechanical ventilation (IMV). Collected from the ICU vital signs chart.

Days with endotracheal tube (ETT). Collected from the ICU vital signs chart. Days with tracheostomy. Collected from the ICU vital signs chart. Discharge destination (home/healthcare facility). Collected from the medical record, at the time of nursing discharge.

Patient severity in ICU using the Acute Physiology And Chronic Health Evaluation (APACHE) II. Collected from the patient\'s medical record.

Sequential Organ Failure Assessment (SOFA). Collected from the patient\'s medical record.

Nutritional parameters:

Body Mass Index (BMI). We will collect weight and height, referring to the baseline state. Weight measurement: when oral feeding begins, the patient will be weighed on a chair or bed scale. Upon transfer to the ward (chair scale). At one month and three months in the post-ICU clinic. Height measurement: the first time it is possible to measure with a stadiometer.

Biochemical parameters: prealbumin, cholesterol, and C-reactive protein (CRP). Collected from the medical record. The week the swallowing test is performed, the day of transfer to the ward, at discharge, and at 30 days in the clinic.

Existence of ICU-ASD determined using the mV-VST13. To perform the test, the patient must have an adequate level of consciousness, RASS 0, and CAM-ICU negative. The test will always be performed before starting oral intake. If positive, indicating ICU-ASD, it will be repeated weekly, in the ward each week while positive. If it remains positive, it will be followed up in the endocrinology clinic, so data from their assessments will be collected.

Respiratory complications:

Respiratory infections. We collect diagnoses of TRACHEOBRONCHITIS and PNEUMONIA described in the medical record. The diagnosis can occur throughout the follow-up, including visits to the health center and emergency services. Record the date from the medical record.

Bronchoaspiration. Described in the medical record as confirmed or suspected. Bronchoaspiration yes/no and the date it occurs.

Reintubation yes/no. Number of times. Collected from the ICU vital signs chart. Hospital readmissions due to swallowing disorder complications. As described in the admission note. Collected from the computerized medical record.

Emergency visits due to swallowing disorder complications. Collected from the computerized medical record.

Quality of life, using the Swallowing Quality of Life Questionnaire for adults (SWAL-QoL). The SWAL-QoL consists of 44 items distributed in 11 domains: meal duration, desire to eat, food selection, communication, burden, fear, social role, mental health, fatigue, and sleep. It is easy to apply and provides information on self-perception of quality of life. It assesses the impact of dysphagia on the patient, symptoms, how dysphagia affects food choices, the social impact of dysphagia, among others. Each item is rated from 1 to 5 (1 represents the worst state and 5 represents the most favorable state) and is grouped into 10 scales that are evaluated independently (with 0% being the least favorable and 100% the most favorable). Lower scores are associated with poorer quality of life.

Death yes/no. If it occurs from inclusion in the study until its completion. If it occurs, the date of death will be recorded. Collected from the medical record.

Nutritional adaptation. Prescribed diet (type of hospital diet or enteral nutrition) and route of administration: oral, NG tube, or percutaneous endoscopic gastrostomy (PEG).

An ad hoc data collection form has been developed, where all study variables will be recorded on a sheet for each participant. Data will be safeguarded to preserve participants\' privacy and confidentiality, and a database will be created for subsequent analysis.

Data Collection

After receiving approval from the Research Ethics Committee for Medicines (CEIm) of the Albacete Health Area, as well as authorization from the department head and ICU supervisor at CHUA, and once the suitability of the facilities has been verified, data collection will begin for those patients who meet the inclusion criteria and sign the informed consent, after having received verbal information. All participants will undergo dysphagia assessment using the mV-VST, and the recording of variables in the specially designed data collection notebook will commence.

The mV-VST is based on testing three textures: nectar, pudding, and liquid, prepared with mineral water and a thickener. In this study, the thickener currently available in the unit will be used, and the staff will be properly trained in its use. The test begins with the nectar texture, gradually increasing the volumes to 5, 10, and 15 ml, which are deposited consecutively into the mouth using a wide-cone 50 ml syringe. These textures will be colored with blue food coloring to better visualize possible pulmonary aspirations, distinguishing them from normal secretions, which is especially important in tracheotomized patients.