TerminatedNot Applicable

Post-extubation Dysphagia

Stopped: Organizational issues and slow inclusion rate

Netherlands5 participantsStarted 2019-01-22

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

The number of patients with aspiration during FEES will be assessed.

Timeframe: At time of measurement (within 24 hours post-extubation)

Trial details

NCT IDNCT03761823

SponsorRadboud University Medical Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2019-02-28