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Completed

NCT Number: NCT01789424

Valuation of Swallowing 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).

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ospedale San Raffaele

Milan, Italy, 20100

About this study

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:

  • No penetration in the airway
  • Bolus reaches the airway, it does not reach vocal cords and it is completely eliminated
  • Bolus reaches the airway, it does not reach vocal cords but it is not completely eliminated
  • Bolus reaches the airway, it reaches vocal cords but it is completely eliminated
  • Bolus reaches the airway, it reaches vocal cords and it is not completely eliminated
  • Bolus reaches the airway, it passes trough vocal cords but it is completely eliminated
  • Bolus reaches the airway, it passes trough vocal cords, it is not eliminated but patient strives to expel it
  • 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:

  • Normal swallowing : no aspiration or penetration in the airway
  • Trivial swallowing impairment: oral or pharyngeal impairment that causes occasional airway penetration with rapid clearance
  • 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
  • Moderate-severe swallowing impairment: oral or pharyngeal impairment that causes an important aspiration of a similar viscosity aliment
  • Severe swallowing impairment: oral or pharyngeal impairment that causes an important aspiration of similar or different viscosity

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Swallowing impairment

    Time frame: 12 months

    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)

Secondary outcomes

  1. Inhalation

    Time frame: 12 months

    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)

Sponsors and collaborators

Lead sponsor

Ospedale San Raffaele

Other

Registry information

Official study title

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

Acronym: SwallSed

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Feb 12, 2013
Registry last updated
Mar 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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