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Valuation of Swallowing in Patient Sedated for Gastroenteric Endoscopic Procedure

Valuation of Airway Protection (Swalling) in Patient Sedated for Gastroenteric Endoscopic Procedure

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01789424
Acronym
SwallSed
Enrollment
80
Registered
2013-02-12
Start date
2012-05-31
Completion date
2013-12-31
Last updated
2015-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aspiration of Food, Deglutition Disorders, Sedation for Gastroenteric Endoscopic Procedure

Brief 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).

Detailed description

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: * laryngeal fibroscopy to evaluate vocal cord motility * swallowing trial using 3 blue colored water bolus (3-4ml) and computing a Penetration-aspiration scale and an Aspiration risk scale Rosenbek, Robbins et al. A Penetration-Aspiration Scale. Dysphagia 11:93-98, 1996: 1. No penetration in the airway 2. Bolus reaches the airway, it does not reach vocal cords and it is completely eliminated 3. Bolus reaches the airway, it does not reach vocal cords but it is not completely eliminated 4. Bolus reaches the airway, it reaches vocal cords but it is completely eliminated 5. Bolus reaches the airway, it reaches vocal cords and it is not completely eliminated 6. Bolus reaches the airway, it passes trough vocal cords but it is completely eliminated 7. Bolus reaches the airway, it passes trough vocal cords, it is not eliminated but patient strives to expel it 8. Bolus reaches the airway, it passes trough vocal cords, it is not eliminated and patient does not strive to expel it Daniels e coll.: Clinical Predictors of Dysphagia and Aspiration Risk: Outcome Measures in Acute Stroke Patients. Arch Phys Med Rehab Vol 81, August 2000: 1. Normal swallowing : no aspiration or penetration in the airway 2. Trivial swallowing impairment: oral or pharyngeal impairment that causes occasional airway penetration with rapid clearance 3. Moderate swallowing impairment: oral or pharyngeal impairment that causes consistent airway penetration with stasis into the vestibule or two or less event of aspiration of a similar viscosity aliment 4. Moderate-severe swallowing impairment: oral or pharyngeal impairment that causes an important aspiration of a similar viscosity aliment 5. Severe swallowing impairment: oral or pharyngeal impairment that causes an important aspiration of similar or different viscosity

Interventions

None listed

Sponsors

Ospedale San Raffaele
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* American Society of Anesthesiologists (ASA) physical status I-II-III * Able to give written consent with none

Exclusion criteria

.

Design outcomes

Primary

MeasureTime frameDescription
Swallowing impairment12 monthsPrimary 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: * laryngeal fibroscopy to evaluate vocal cord motility * swallowing trial using 3 blue colored water bolus (3-4ml) and computing a Penetration-aspiration scale and an Aspiration risk scale (see above)

Secondary

MeasureTime frameDescription
Inhalation12 monthsSecondary 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: * laryngeal fibroscopy to evaluate vocal cord motility * swallowing trial using 3 blue colored water bolus (3-4ml) and computing a Penetration-aspiration scale and an Aspiration risk scale (see above)

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026