Valuation of Swallowing in Patient Sedated for Gastroenteric Endoscopic Procedure (NCT01789424) | Clinical Trial Compass
CompletedNot Applicable
Valuation of Swallowing in Patient Sedated for Gastroenteric Endoscopic Procedure
Italy80 participantsStarted 2012-05
Plain-language summary
Aim of this study is to evaluate swallowing functionality in patient sedated for gastroenteric endoscopic procedure.
Swallowing will be study by laryngeal fibroscopy and evaluate using Penetration-Aspiration Scale and Aspiration Risk validated in scientific literature.
Aim of the study is to describe swallowing, as an expression of airway protection, in sedated patient. in particular, our purpose is to determine the incidence of moderate-severe and severe swallowing alteration (level 3 or 4 of Aspiration Risk scale).
Who can participate
Age range
18 Years – 80 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:
* American Society of Anesthesiologists (ASA) physical status I-II-III
* Able to give written consent with none exclusion criteria.
Exclusion Criteria:
* presence of feeding tube
* presence of tracheostomy actual or in the past
* severe respiratory deficit
* neurological disease which can compromise swallowing function
* history of surgery for mouth or pharyngeal or esophageal cancer
* history of otolaryngology surgery
* faring-laryngeal radiotherapy
* emergent procedure
* psychic alteration
* patient in therapy with any kind of antidepressant drugs
* insulin dependent diabetes mellitus patient
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.