Clinical trial NCT03761823: Post-extubation Dysphagia
Official title: The Pathophysiology of Post-extubation Dysphagia in ICU Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Post-extubation Dysphagia
Keywords: Flexible endoscopic evaluation of swallowing
High resolution impedance manometry
Electromyography
Intensive Care Unit
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2018-12-03
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy subjects will be recruited using posters at the local university and the internet.

Intensive care patients that will be extubated shortly.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The number of patients with aspiration during FEES will be assessed.
timeFrame: At time of measurement (within 24 hours post-extubation)
Secondary outcomes:
measure: Pathophysiology of PED
timeFrame: At time of measurement (within 24 hours post-extubation)
measure: The number of adverse events will be assessed.
timeFrame: Participants will be followed until hospital discharge, an expected average of 28 days
measure: Interaction of FEES on HRIM recording
timeFrame: At time of measurement (within 24 hours post-extubation)
measure: Correlation of FEES with HRIM
timeFrame: At time of measurement (within 24 hours post-extubation)
Other outcomes:
measure: The number of patients that develop pneumonia will be assessed.
timeFrame: Participants will be followed until hospital discharge, an expected average of 28 days
measure: Reintubation rate (dysphagia vs. non-dysphagia)
timeFrame: Participants will be followed until hospital discharge, an expected average of 28 days
measure: ICU readmission rate (dysphagia vs. non-dysphagia)
timeFrame: Participants will be followed until hospital discharge, an expected average of 28 days
measure: Length of ICU stay (dysphagia vs. non-dysphagia)
timeFrame: Participants will be followed until hospital discharge, an expected average of 28 days
measure: Length of hospital stay (dysphagia vs. non-dysphagia)
timeFrame: Participants will be followed until hospital discharge, an expected average of 28 days
measure: ICU mortality (dysphagia vs. non-dysphagia)
timeFrame: Participants will be followed until hospital discharge, an expected average of 28 days
measure: Hospital mortality (dysphagia vs. non-dysphagia)
timeFrame: Participants will be followed until hospital discharge, an expected average of 28 days
Locations:
city: Nijmegen
country: Netherlands
facility: Radboudumc
Study officials:
affiliation: Radboud University Medical Center
name: Johannes G. van der Hoeven, prof. dr.
role: PRINCIPAL_INVESTIGATOR
References: