Deglutition DisordersDICE-SWISSNCT03487510
Dysphagia on the Intensive Care Unit
An observational study of Deglutition Disorders, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Recording of routine practice patterns to detect and/or treat Dysphagia on the ICU via interview of local colleagues. This will not allow to record generalizable data, but will reflect the actual routine standard of care. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Deglutition Disorders
- How many people
- 49 participants
- Where
- 1 siteSwitzerland
- Study dates
- 11 Nov 2017to 1 May 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Senior local ICU physicians (Swiss ICUs only).
Who may be able to join
- All senior ICU physicians in charge for adult critically ill ICU patients. Respective ICUs must be accredited by the "Schweizerische Gesellschaft für Intensivmedizin".
- ICUs located in Switzerland.
- Senior ICU physicians willing to voluntarily fill in the provided questionnaire.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Dept. of Intensive Care Medicine, University of Bern,
Bern, 3010
About this study
Official title: Dysphagia on the Intensive Care Unit - a Multinational European Analysis
Recording of routine practice patterns to detect and/or treat Dysphagia on the ICU via interview of local colleagues. This will not allow to record generalizable data, but will reflect the actual routine standard of care.
- Conditions
- Deglutition Disorders
- Being tested
- NO interventions apply
- Keywords
- treatment standards, diagnostical approaches, descriptive
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NO interventions applyOther
does not apply
| Study group | Role | What they receive |
|---|---|---|
| NO groups | no groups apply. Receives: Other: NO interventions apply |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of centers using fibre-optic endoscopic evaluation of swallowing (FEES) vs. non-instrumental methods to detect/ treat dysphagia on the ICU.
Analysis of number of ICUs using instrumental methods (FEES) vs. non-instrumental methods in local (Swiss) centers to detect dysphagia in the ICU.
Measured: through study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2018
- Study start11 Nov 2017
- Primary completion1 May 2018
- Study completion1 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deglutition DisordersStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- 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
- Ecologic or community
- Time perspective
- Other
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jörg Schefold, Insel Gruppe AG, University Hospital Bern
- Investigators
- Patrick Zürcher, MD, Principal investigator, Inselspital, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03487510
- Sponsor's protocol ID
- DICE
- Acronym
- DICE-SWISS
- Status last verified
- May 2018
- First submitted
- 9 Mar 2018
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dysphagia on the Intensive Care Unit - a Multinational European Analysis
- ClinicalTrials.gov ID
- NCT03487510
- Acronym / sponsor ID
- DICE-SWISS / DICE
- Conditions
- Deglutition Disorders
- Keywords
- treatment standards, diagnostical approaches, descriptive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 11 Nov 2017 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 4 Apr 2018 (actual)
- 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.
Recording of routine practice patterns to detect and/or treat Dysphagia on the ICU via interview of local colleagues. This will not allow to record generalizable data, but will reflect the actual routine standard of care.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NO groups | – | Other: NO interventions applyno groups apply. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Senior local ICU physicians (Swiss ICUs only).
Key inclusion criteria (3 listed)
- All senior ICU physicians in charge for adult critically ill ICU patients. Respective ICUs must be accredited by the "Schweizerische Gesellschaft für Intensivmedizin".
- ICUs located in Switzerland.
- Senior ICU physicians willing to voluntarily fill in the provided questionnaire.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NO interventions applydoes not apply | Other | NO groups |
Primary outcome
Number of centers using fibre-optic endoscopic evaluation of swallowing (FEES) vs. non-instrumental methods to detect/ treat dysphagia on the ICU.
Time frame: through study completion, an average of 1 month
Analysis of number of ICUs using instrumental methods (FEES) vs. non-instrumental methods in local (Swiss) centers to detect dysphagia in the ICU.
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 12 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Patrick Zürcher, MD principal investigator
Inselspital, University of Bern
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 Deglutition Disorders, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 3 inclusion and 0 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 12 Nov 2024. 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 Switzerland. 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?
Number of centers using fibre-optic endoscopic evaluation of swallowing (FEES) vs. non-instrumental methods to detect/ treat dysphagia on the ICU. (time frame: through study completion, an average of 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Nov 2024.