An observational study in Post-extubation Dysphagia, sponsored by Radboud University Medical Center. Terminated at 1 site in Netherlands. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-11.
Sponsored by Radboud University Medical Center · Observational
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.
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.
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Healthy subjects will be recruited using posters at the local university and the internet.
Intensive care patients that will be extubated shortly.
Inclusion Criteria (patients):
Inclusion Criteria (healthy subjects):
Exclusion Criteria (both patients and healthy subjects):
Healthy subjects
Patients extubated after \> 5 days of mechanical ventilation.
The number of patients with aspiration during FEES will be assessed.
Time frame: At time of measurement (within 24 hours post-extubation)
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).
Time frame: At time of measurement (within 24 hours post-extubation)
The number of adverse events will be assessed.
Time frame: 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.
Time frame: 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.
Time frame: At time of measurement (within 24 hours post-extubation)
The number of patients that develop pneumonia will be assessed.
Pneumonia is defined according to the Center of Disease Control criteria.
Time frame: Participants will be followed until hospital discharge, an expected average of 28 days
Reintubation rate (dysphagia vs. non-dysphagia)
The number of patients that are reintubated during their hospital stay will be assessed.
Time frame: Participants will be followed until hospital discharge, an expected average of 28 days
ICU readmission rate (dysphagia vs. non-dysphagia)
The number of patients that are readmitted to the ICU during their hospital stay will be assessed.
Time frame: Participants will be followed until hospital discharge, an expected average of 28 days
Length of ICU stay (dysphagia vs. non-dysphagia)
Length of ICU stay will be assessed (in days).
Time frame: Participants will be followed until hospital discharge, an expected average of 28 days
Length of hospital stay (dysphagia vs. non-dysphagia)
Length of hospital stay will be assessed (in days).
Time frame: Participants will be followed until hospital discharge, an expected average of 28 days
ICU mortality (dysphagia vs. non-dysphagia)
The incidence of mortality during ICU stay will be assessed.
Time frame: Participants will be followed until hospital discharge, an expected average of 28 days
Hospital mortality (dysphagia vs. non-dysphagia)
The incidence of mortality during hospital stay will be assessed.
Time frame: Participants will be followed until hospital discharge, an expected average of 28 days
This study is terminated, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Radboud University Medical Center