Status:
TERMINATED
Post-extubation Dysphagia
Lead Sponsor:
Radboud University Medical Center
Conditions:
Post-extubation Dysphagia
Eligibility:
All Genders
18+ years
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: pneu...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 22 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 28 2019
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT03761823
Start Date
January 22 2019
End Date
February 28 2019
Last Update
April 11 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Radboudumc
Nijmegen, Netherlands