Sedation for Gastroenteric Endoscopic ProcedureSwallSedNCT01789424
Valuation of Swallowing in Patient Sedated for Gastroenteric Endoscopic Procedure
An observational study of Sedation for Gastroenteric Endoscopic Procedure and Deglutition Disorders, run by Ospedale San Raffaele at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sedation for Gastroenteric Endoscopic Procedure, Deglutition Disorders, Aspiration of Food
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- May 2012to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient sedated for gastroenteric endoscopic examination
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status I-II-III
- Able to give written consent with none exclusion criteria.
Who cannot join
- 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
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- faring-laryngeal radiotherapy
- emergent procedure
- psychic alteration
- patient in therapy with any kind of antidepressant drugs
- insulin dependent diabetes mellitus patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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:
- 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
- Conditions
- Sedation for Gastroenteric Endoscopic Procedure, Deglutition Disorders, Aspiration of Food
- Medical subject headings
- Deglutition Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 12 months
Secondary outcomes (1)
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)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2013 (estimated)
- Study startMay 2012
- Primary completionMay 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sedation for Gastroenteric Endoscopic ProcedureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agostoni Massimo, Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01789424
- Sponsor's protocol ID
- Swallsed
- Other IDs
- Swallsed2012
- Acronym
- SwallSed
- Status last verified
- Mar 2015
- First submitted
- 28 Jan 2013
- Last updated
- 17 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 26049781
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Valuation of Airway Protection (Swalling) in Patient Sedated for Gastroenteric Endoscopic Procedure
- ClinicalTrials.gov ID
- NCT01789424
- Acronym / sponsor ID
- SwallSed / Swallsed
- Conditions
- Sedation for Gastroenteric Endoscopic Procedure, Deglutition Disorders, Aspiration of Food
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ospedale San RaffaeleUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- May 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 12 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient sedated for gastroenteric endoscopic examination
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) physical status I-II-III
- Able to give written consent with none exclusion criteria.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
1 secondary outcome
Inhalation
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2015.
- Derived from this study: PubMed 26049781Gemma 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sedation for Gastroenteric Endoscopic Procedure and Deglutition Disorders, run by Ospedale San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Swallowing impairment (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01789424, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2015.