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 range
18 Years
Sex
ALL
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The number of patients with aspiration during FEES will be assessed.
Timeframe: At time of measurement (within 24 hours post-extubation)