Post-extubation Dysphagia

Post-extubation Dysphagia Clinical Trial

Official title:

The Pathophysiology of Post-extubation Dysphagia in ICU Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03761823
• Other study ID #: DYSPHAGIA ICU HH17
• Status: Terminated
• Start date: January 22, 2019
• Est. completion date: February 28, 2019

Study information

• Verified date: March 2022
• Source: Radboud University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: February 28, 2019
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deglutition Disorders
• Post-extubation Dysphagia

Locations

Country	Name	City	State
Netherlands	Radboudumc	Nijmegen

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The number of patients that develop pneumonia will be assessed.	Pneumonia is defined according to the Center of Disease Control criteria.	Participants will be followed until hospital discharge, an expected average of 28 days
Other	Reintubation rate (dysphagia vs. non-dysphagia)	The number of patients that are reintubated during their hospital stay will be assessed.	Participants will be followed until hospital discharge, an expected average of 28 days
Other	ICU readmission rate (dysphagia vs. non-dysphagia)	The number of patients that are readmitted to the ICU during their hospital stay will be assessed.	Participants will be followed until hospital discharge, an expected average of 28 days
Other	Length of ICU stay (dysphagia vs. non-dysphagia)	Length of ICU stay will be assessed (in days).	Participants will be followed until hospital discharge, an expected average of 28 days
Other	Length of hospital stay (dysphagia vs. non-dysphagia)	Length of hospital stay will be assessed (in days).	Participants will be followed until hospital discharge, an expected average of 28 days
Other	ICU mortality (dysphagia vs. non-dysphagia)	The incidence of mortality during ICU stay will be assessed.	Participants will be followed until hospital discharge, an expected average of 28 days
Other	Hospital mortality (dysphagia vs. non-dysphagia)	The incidence of mortality during hospital stay will be assessed.	Participants will be followed until hospital discharge, an expected average of 28 days
Primary	The number of patients with aspiration during FEES will be assessed.		At time of measurement (within 24 hours post-extubation)
Secondary	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)
Secondary	The number of adverse events will be assessed.		Participants will be followed until hospital discharge, an expected average of 28 days
Secondary	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)
Secondary	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)