Valuation of Swallowing in Patient Sedated for Gastroenteric Endoscopic Procedure

NCT ID: NCT01789424

Last Updated: 2015-03-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2013-12-31

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

Conditions

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ospedale San Raffaele

OTHER

Sponsor Role: lead

Responsible Party

Agostoni Massimo

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ospedale San Raffaele

Milan, Italy, Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 26049781 (View on PubMed)

Other Identifiers

Swallsed2012

Identifier Type: -

Identifier Source: secondary_id

Swallsed

Identifier Type: -

Identifier Source: org_study_id