Valuation of Swallowing in Patient Sedated for Gastroenteric Endoscopic Procedure

NCT01789424 | Completed

• 2 other identifiers: SwallsedSwallsed2012
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Inhalation

  12 months

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient sedated for gastroenteric endoscopic examination

You may qualify if:

• American Society of Anesthesiologists (ASA) physical status I-II-III

You may not qualify if:

• 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

Sponsors & Collaborators

• Ospedale San Raffaele: lead

Study Sites (1)

Ospedale San Raffaele

Milan, Italy, 20100, Italy

Location

Related Publications (1)

• 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.

  PMID: 26049781 DERIVED

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: January 28, 2013
• First Posted: February 12, 2013
• Study Start: May 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: December 1, 2013
• Last Updated: March 17, 2015

Record last verified: 2015-03

Locations

IT (1)