Valuation of Swallowing in Patient Sedated for Gastroenteric Endoscopic Procedure (SwallSed)

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

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).

Study Overview

• Status: Completed
• Conditions: Deglutition Disorders; Sedation for Gastroenteric Endoscopic Procedure; Aspiration of Food

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

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20100
    • Ospedale San Raffaele

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient sedated for gastroenteric endoscopic examination

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Swallowing impairment	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: 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)	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inhalation	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: 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)	12 months

Collaborators and Investigators

• Sponsor: Ospedale San Raffaele

Publications and helpful links

General Publications

• Gemma M, Pasin L, Oriani A, Agostoni M, Palonta F, Ramella B, Bussi M, Beretta L. Swallowing Impairment During Propofol Target-Controlled Infusion. Anesth Analg. 2016 Jan;122(1):48-54. doi: 10.1213/ANE.0000000000000796.

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (ACTUAL): May 1, 2013
• Study Completion (ACTUAL): December 1, 2013

Study Registration Dates

• First Submitted: January 28, 2013
• First Submitted That Met QC Criteria: February 8, 2013
• First Posted (ESTIMATE): February 12, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): March 17, 2015
• Last Update Submitted That Met QC Criteria: March 13, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Deglutition Disorders
• Other Study ID Numbers: Swallsed; Swallsed2012