Continuous low-pressure pyriform recess drainage to prevent occult aspiration in ICU-acquired dysphagia patients Infections and Infestations
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age =18 years 2. ICU admission with invasive mechanical ventilation for = 48 hours and extubation 3. Conscious patients assessed as having ICU-ASD by GUSS within 24 hours of extubation 4. Tracheostomy patients who have recovered stable consciousness and are able to complete functional assessments 5. Agree to participate in this study and sign informed consent form
Exclusion criteria
Exclusion criteria: 1. Impaired consciousness preventing completion of swallowing assessment 2. Severe cognitive impairment or mental illness 3. Comorbid severe oropharyngeal bleeding tendency or coagulation dysfunction 4. Pre-existing aspiration or aspiration pneumonia 5. Comorbid gastroesophageal reflux or tracheoesophageal fistula, or other diseases that may affect the study results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Swallowing function recovery time measured using data collected from medical records on the number of days from randomization to the first day the patient achieved full oral intake of regular solids and thin liquids without signs of aspiration, maintained SaO2 >90% on room air during swallowing, and had a normal swallow exam by the speech therapist (Gugging Swallowing Screen [GUSS] score = 20) at a daily assessment by ICU nurses and formal evaluation every 2–3 days by a trained speech-language pathologist until recovery or censored (ICU discharge or day 28);ICU length of stay (LOS) measured using data collected from medical records on the number of days from ICU admission to ICU discharge (or death in ICU if applicable) at one time point | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of silent aspiration, in the absence of overt clinical signs of aspiration (no coughing, choking, wet voice, or desaturation during the event) measured using the detection of pepsin (>25 ng/mL by quantitative ELISA, PepTest®) in tracheal aspirates (intubated patients) or oropharyngeal/tracheal secretions (extubated or tracheostomized patients) at study days 1, 3, 5, and 7;Incidence of aspiration pneumonia measured using data collected from medical records on new lung infiltrate on chest X-ray plus =2 of the following: fever >38°C or WBC >12×10?/L, purulent sputum, positive respiratory culture; and evidence of aspiration risk (witnessed aspiration event or positive pepsin assay in respiratory secretions); all cases were adjudicated by two independent ICU physicians blinded to allocation at one time point;28-day and 90-day all-cause mortality measured using data collected from medical records on all-cause mortality recorded at day 28 and day 90 after ICU admission, confirmed via hospital records and post-discharge telephone follow-up at at one time point;Inflammatory markers: Serum C-reactive protein (CRP, mg/L) and white blood cell count (WBC, ×10?/L) measured using standard hospital laboratory methods (routine venous blood sampling; CRP assay performed in the central laboratory; automated hematology analyser) at ICU day 5 (±1 day) (with baseline values recorded at enrolment/ICU admission as per routine clinical practice);Swallowing-related outcomes measured using the Gugging Swallowing Screen (GUSS) score (0–20) at daily until recovery time to resumption of any oral feeding (days from randomization to first successful oral intake of any consistency), or need for re-intubation for airway protection | — |
Countries
China
Contacts
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