Post-extubation Dysphagia
Conditions
Keywords
Flexible endoscopic evaluation of swallowing, High resolution impedance manometry, Electromyography, Intensive Care Unit
Brief summary
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
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.
Interventions
None listed
Sponsors
Radboud University Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of patients with aspiration during FEES will be assessed. | At time of measurement (within 24 hours post-extubation) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pathophysiology of PED | At time of measurement (within 24 hours post-extubation) | 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). |
| 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 | At time of measurement (within 24 hours post-extubation) | HRIM outcomes during the simultaneous recording will be compared with outcomes of recording with only HRIM in situ. |
| Correlation of FEES with HRIM | At time of measurement (within 24 hours post-extubation) | The correlation of FEES outcomes, e.g. PAS and residue, with HRIM outcomes, e.g. swallow risk index and post-swallow impedance ratio. |
Other
| Measure | Time frame | Description |
|---|---|---|
| ICU mortality (dysphagia vs. non-dysphagia) | Participants will be followed until hospital discharge, an expected average of 28 days | The incidence of mortality during ICU stay will be assessed. |
| Reintubation rate (dysphagia vs. non-dysphagia) | Participants will be followed until hospital discharge, an expected average of 28 days | The number of patients that are reintubated during their hospital stay will be assessed. |
| Hospital mortality (dysphagia vs. non-dysphagia) | Participants will be followed until hospital discharge, an expected average of 28 days | The incidence of mortality during hospital stay will be assessed. |
| ICU readmission rate (dysphagia vs. non-dysphagia) | Participants will be followed until hospital discharge, an expected average of 28 days | The number of patients that are readmitted to the ICU during their hospital stay will be assessed. |
| Length of ICU stay (dysphagia vs. non-dysphagia) | Participants will be followed until hospital discharge, an expected average of 28 days | Length of ICU stay will be assessed (in days). |
| Length of hospital stay (dysphagia vs. non-dysphagia) | Participants will be followed until hospital discharge, an expected average of 28 days | Length of hospital stay will be assessed (in days). |
| The number of patients that develop pneumonia will be assessed. | Participants will be followed until hospital discharge, an expected average of 28 days | Pneumonia is defined according to the Center of Disease Control criteria. |
Countries
Netherlands
Outcome results
None listed