Post-extubation Dysphagia

Radboud University Medical Center

Status: Terminated

Conditions: Post-extubation Dysphagia

Study type: Observational

Funder types: Other

Identifiers

NCT03761823

DYSPHAGIA ICU HH17

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

5 participants in 2 patient groups

Healthy subjects

Description:

Healthy subjects

Patients

Description:

Patients extubated after \> 5 days of mechanical ventilation.