Post-extubation Dysphagia

The Pathophysiology of Post-extubation Dysphagia in ICU Patients

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.

Study Overview

• Status: Terminated
• Conditions: Post-extubation Dysphagia

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.

• Study Type: Observational
• Enrollment (Actual): 5

Contacts and Locations

Study Locations

• Netherlands
  • Nijmegen, Netherlands
    • Radboudumc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Healthy subjects
Patients; Patients extubated after > 5 days of mechanical ventilation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Investigators: Principal Investigator: Johannes G. van der Hoeven, prof. dr., Radboud University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2019
• Primary Completion (Actual): February 28, 2019
• Study Completion (Actual): February 28, 2019

Study Registration Dates

• First Submitted: February 2, 2018
• First Submitted That Met QC Criteria: November 30, 2018
• First Posted (Actual): December 3, 2018

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Intensive Care Unit; Electromyography; Flexible endoscopic evaluation of swallowing; High resolution impedance manometry
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Deglutition Disorders
• Other Study ID Numbers: DYSPHAGIA ICU HH17

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No