Ospedale San Raffaele
Milan, Italy, 20100
NCT Number: NCT01789424
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).
Looking for future studies?
Notify Me18 year–80 year
All sexes
Observational
Milan, Italy, 20100
All patients will be sedated using propofol target controlled infusion (TCI) with a target of 2-5 mcg/ml During sedation and examination will be monitored: cardiac frequency, peripheral oxygen saturation and non-invasive arterial blood pressure.
During sedation, before starting the gastroenteric endoscopic exam, will be performed a fibroscopic swallowing evaluation made by an expert otolaryngologist.
Fibroscopic evaluation consist of:
Rosenbek, Robbins et al. A Penetration-Aspiration Scale. Dysphagia 11:93-98, 1996:
Daniels e coll.: Clinical Predictors of Dysphagia and Aspiration Risk: Outcome Measures in Acute Stroke Patients. Arch Phys Med Rehab Vol 81, August 2000:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 12 months
Primary outcomes of this study is to verify if there is any kind of swallowing impairment during sedation with propofol and to quantify the eventual impairment.
Swallowing function will be study by fibroscopic evaluation, that consists of:
Time frame: 12 months
Secondary outcome of this study is to determine if the eventual swallowing impairment during propofol sedation causes inhalation in the airway.
We use fibroscopic evaluation to identify and to quantify the possible inhalation.
The fibroscopic evaluation consists of:
Ospedale San Raffaele
Other
Valuation of Airway Protection (Swalling) in Patient Sedated for Gastroenteric Endoscopic Procedure
Acronym: SwallSed
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06719960
Cognition, Geriatric Patients
Ankara, Turkey (Türkiye)
View Trial DetailsNCT07726667
Autoimmune Diseases, Autoimmune Diseases of the Nervous System
Gaziantep, Gaz, Turkey (Türkiye)
View Trial DetailsNCT02170506
Deglutition Disorders, Digestive System Diseases
Rouen, France
View Trial DetailsNCT05439447
Deglutition Disorders, Digestive System Diseases
Seongnam-si, Gyeonggi-do, South Korea
View Trial Details