- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04180449
DYsphagiA in interMedIate Care UnitS (DYnAMICS II)
November 29, 2023 updated by: Insel Gruppe AG, University Hospital Bern
DYsphagiA in interMedIate Care UnitS - a Retrospective Analysis of Available Data
Retrospective study in intermediate care unit patients on the incidence, Risk factors, and effects on mortality of dysphagia.
During a 6-month observational period, routine data will be collected and analysed.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
1400
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Bern, Switzerland
- Dept of Intensive Care Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Intermediate Care unit patients
Description
Inclusion Criteria:
- Intermediate care unit patients admitted within the observational period
Exclusion Criteria:
- documented refusal to General Consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Dysphagia screening positive
|
Screening for dysphagia using the water swallow test in intermediate care unit patients
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Dysphagia screening negative
|
Screening for dysphagia using the water swallow test in intermediate care unit patients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of positive screening (first screening) for dysphagia in neurosurgical intermediate care unit patients
Time Frame: within 8 hours from intermediate care unit admission
|
incidence: percentage of patients with screening positivity at first screening
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within 8 hours from intermediate care unit admission
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Zuercher P, Moret CS, Dziewas R, Schefold JC. Dysphagia in the intensive care unit: epidemiology, mechanisms, and clinical management. Crit Care. 2019 Mar 28;23(1):103. doi: 10.1186/s13054-019-2400-2.
- Schefold JC, Berger D, Zurcher P, Lensch M, Perren A, Jakob SM, Parviainen I, Takala J. Dysphagia in Mechanically Ventilated ICU Patients (DYnAMICS): A Prospective Observational Trial. Crit Care Med. 2017 Dec;45(12):2061-2069. doi: 10.1097/CCM.0000000000002765.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 14, 2020
Primary Completion (Estimated)
November 1, 2024
Study Completion (Estimated)
December 1, 2024
Study Registration Dates
First Submitted
November 25, 2019
First Submitted That Met QC Criteria
November 25, 2019
First Posted (Actual)
November 27, 2019
Study Record Updates
Last Update Posted (Actual)
November 30, 2023
Last Update Submitted That Met QC Criteria
November 29, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DYnAMICS II
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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