Post-extubation Dysphagia

Study Overview
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Brief Summary
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Mechanical ventilation is a widely used treatment on the Intensive Care Unit (ICU). Swallowing dysfunction (dysphagia) after extubation may cause aspiration, and is associated with poor outcomes: pneumonia, reintubation, a prolonged length of hospital stay and increased mortality. The exact underlying pathophysiology of post-extubation dysphagia (PED) is unknown. This exploratory pilot study is the first step that aims to fill this knowledge gap to ultimately improve current treatment and prevention of post-extubation dysphagia. Using FEES (Flexible Endoscopic Evaluation of Swallowing), HRIM (High Resolution Impedance Manometry) and EMG (electromyography) simultaneously, 5 healthy subjects and 25 patients within 24 hours after extubation will be studied.

Detailed Description
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Observational study model: The group of healthy subjects will be recruited using posters at the local university and the internet. The healthy subjects will be studied before the group of patients to assess the feasibility and possible interactions of simultaneously recording FEES, HRIM and EMG. Then, the group of patients will be studied. They will be recruited from the Intensive Care Unit. See In- and Exclusion criteria for details.

Official Title
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The Pathophysiology of Post-extubation Dysphagia in ICU Patients

Conditions
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Post-extubation Dysphagia

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria (patients): age > 18 years informed consent extubated after endotracheal intubation for more than 5 days Richmond Agitation-Sedation Scale (RASS) between -2 and 2 able to sit right up no respiratory insufficiency/failure (for this study defined as oxygen saturation (SpO2) < 92% with a minimum of 3 L nasal oxygen) Inclusion Criteria (healthy subjects): age > 18 years informed consent Exclusion Criteria (both patients and healthy subjects): pre-existing dysphagia (according to medical record and screening) tracheostomy or previous tracheostomy history of prior intubation < 3 months ago head/neck surgery, head/neck radiation or head/neck disease pre-existent esophageal disorder coagulopathy (thrombocytes < 50*10^9 /l, or prothrombin time (PT)/activated partial thromboplastin time (APTT) > 1.5 times the reference value, or fibrinogen < 1000 mg/l, or use of therapeutic anticoagulant drugs) allergy for xylometazoline (only in case its use is indicated) known pregnancy known G6PD deficiency

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy subjects<br>Healthy subjects | |
| Patients<br>Patients extubated after > 5 days of mechanical ventilation. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of patients with aspiration during FEES will be assessed. |  | At time of measurement (within 24 hours post-extubation) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathophysiology of PED | The pathophysiology of PED will be determined after simultaneous measurement of FEES, HRIM and EMG. The pathophysiology will be classified into several categories: reduced pharyngeal contractility / muscular weakness, reduced upper esophageal sphincter (UES) opening/relaxation, direct oropharyngeal or laryngeal trauma of the tube, reduced laryngeal sensibility, among other categories. To enable classification, parameters obtained from FEES, HRIM and EMG will be used. FEES: presence of penetration and aspiration, residue, reduced sensibility (among others); HRIM: pharyngeal peak pressure, UES maximum admittance, intrabolus pressure (among others); EMG: duration of muscle activity (among others). | At time of measurement (within 24 hours post-extubation) | 
| The number of adverse events will be assessed. |  | Participants will be followed until hospital discharge, an expected average of 28 days | 
| Interaction of FEES on HRIM recording | HRIM outcomes during the simultaneous recording will be compared with outcomes of recording with only HRIM in situ. | At time of measurement (within 24 hours post-extubation) | 
| Correlation of FEES with HRIM | The correlation of FEES outcomes, e.g. PAS and residue, with HRIM outcomes, e.g. swallow risk index and post-swallow impedance ratio. | At time of measurement (within 24 hours post-extubation) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Flexible endoscopic evaluation of swallowing, High resolution impedance manometry, Electromyography, Intensive Care Unit