Valuation of Swallowing in Patient Sedated for Gastroenteric Endoscopic Procedure

Deglutition Disorders Clinical Trial

— SwallSed  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01789424
• Other study ID #: Swallsed
• Secondary ID: Swallsed2012
• Status: Completed
• Phase: N/A
• First received: January 28, 2013
• Last updated: March 13, 2015
• Start date: May 2012
• Est. completion date: December 2013

Study information

• Verified date: March 2015
• Source: Ospedale San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Observational

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Italy	Ospedale San Raffaele	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes