- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02333201
DYsphAgia In Mechanically Ventilated ICU patientS (DYnAMICS)
DYsphAgia In Mechanically Ventilated ICU patientS (DYnAMICS) - a Prospective Multicentre Observational Analysis
Study Overview
Status
Conditions
Detailed Description
Dysphagia significantly contributes to morbidity and mortality in non-critically ill patients (as e.g. in stroke). Long term consequences of dysphagia include, among others, malnutrition, prolonged enteral tube feeding and increased risk of aspiration. In the present observational analysis, we aim to elucidate the incidence and the impact of dysphagia on the clinical course of a mixed population of ICU patients post invasive mechanical ventilation.
ICU patients are at increased risk for oropharyngeal dysphagia following endotracheal intubation. However, the incidence, respective underlying causes and clinical consequences of dysphagia in ICU patients are currently understudied. The impact on clinical outcomes of respective ICU patients thus remains currently unclear. A systematic review [1] reported highly variable dysphagia frequency rates depending on the time of mechanical ventilation/ intubation.
However, previous clinical trials were heterogeneous in design, methods of screening, and study outcome. The overall quality of evidence is considered low. The systematic review highlights the limited available evidence for dysphagia following intubation and hence the need for high-quality prospective trials. A recent retrospective single-centre trial [2] in a tertiary care ICU demonstrated a high presence of dysphagia in mechanical ventilated (MV) patients following extubation. Screening was performed using bedside swallowing evaluation (BSE).
In a prospective observational analysis, we aim to further elucidate the impact of dysphagia on respective clinical outcomes in ICU patients after mechanical ventilation.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Bern, Switzerland, 3010
- Dept. of Intensive Care Medicine, University of Bern,
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria: all adult ICU patients post mechanical ventilation (observational analysis)
Exclusion Criteria:
- patients prone to die / moribund patients/ or dying patients
- patients post oesophageal resection / with oesophageal rupture
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of patients with dysphagia at discharge from ICU
Time Frame: expected average time frame about 72hrs. (at end of ICU stay/ discharge)
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expected average time frame about 72hrs. (at end of ICU stay/ discharge)
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of patients with dysphagia and dysphagia severity at first assessment
Time Frame: expected average time frame about 48 hrs.
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expected average time frame about 48 hrs.
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Number of patients with dysphagia / incl. dysphagia severity at discharge
Time Frame: expected average time frame about 72 hrs. (end of ICU stay)
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expected average time frame about 72 hrs. (end of ICU stay)
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Number of patients with dysphagia in predefined patient categories: ICU-acquired weakness, stroke/ cerebrovascular infarction, traumatic brain injury, movement disorders, sepsis, cardiogenic, post abdominal surgery, trauma
Time Frame: during ICU stay (expected average length of ICU stay is about 72 hrs.)
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during ICU stay (expected average length of ICU stay is about 72 hrs.)
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Number of patients with dysphagia and (association to) sedatives prescribed
Time Frame: during ICU stay (expected average length of ICU stay is about 72 hrs.)
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during ICU stay (expected average length of ICU stay is about 72 hrs.)
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Number of patients re-intubated, reason for re-intubation, and antibiotic use
Time Frame: during ICU stay (expected average length of ICU stay is about 72 hrs./ observational period)
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during ICU stay (expected average length of ICU stay is about 72 hrs./ observational period)
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Number of patients with dysphagia and association to duration of mechanical ventilation
Time Frame: during ICU stay (expected average length of ICU stay is about 72 hrs.)
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during ICU stay (expected average length of ICU stay is about 72 hrs.)
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Number of patients with dysphagia (in association) to tube size, body weight/ BMI etc.
Time Frame: during ICU stay (expected average length of ICU stay is about 72 hrs./ observational period)
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during ICU stay (expected average length of ICU stay is about 72 hrs./ observational period)
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Number of patients with dysphagia according to disease severity and routine laboratory indices
Time Frame: during ICU stay (expected average length of ICU stay is about 72 hrs./ observational period)
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during ICU stay (expected average length of ICU stay is about 72 hrs./ observational period)
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Duration of dysphagia/ course of dysphagia severity during ICU/ hospital stay
Time Frame: during ICU stay (expected average length of ICU stay is about 72 hrs./ observational period, expected average length of hospital stay is about 14 days)
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during ICU stay (expected average length of ICU stay is about 72 hrs./ observational period, expected average length of hospital stay is about 14 days)
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Number of chest X-ray examinations performed among patients w/ and w/o dysphagia
Time Frame: during ICU stay (expected average length of ICU stay is about 72 hrs./ observational period, expected average length of hospital stay is about 14 days)
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during ICU stay (expected average length of ICU stay is about 72 hrs./ observational period, expected average length of hospital stay is about 14 days)
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Association of dysphagia and related ICU length of stay/ hospital length of stay
Time Frame: during ICU stay (expected average length of ICU stay is about 72 hrs./ observational period)
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during ICU stay (expected average length of ICU stay is about 72 hrs./ observational period)
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Association of dysphagia and related ICU- and intrahospital mortality/ readmission rate
Time Frame: during ICU stay (expected average length of ICU stay is about 72 hrs./ observational period)
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during ICU stay (expected average length of ICU stay is about 72 hrs./ observational period)
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Other clinical/ epidemiological factors associated with dysphagia (incl. descriptive analyses)
Time Frame: during ICU stay (expected average length of ICU stay is about 72 hrs./ observational period)
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during ICU stay (expected average length of ICU stay is about 72 hrs./ observational period)
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Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Jukka Takala, Prof Dr., University of Bern, Inselspital
- Study Chair: Stephan Jakob, Prof. Dr., University of Bern, Inselspital
- Principal Investigator: Joerg C Schefold, MD, University of Bern, Inselspital
Publications and helpful links
General Publications
- Skoretz SA, Flowers HL, Martino R. The incidence of dysphagia following endotracheal intubation: a systematic review. Chest. 2010 Mar;137(3):665-73. doi: 10.1378/chest.09-1823.
- Macht M, King CJ, Wimbish T, Clark BJ, Benson AB, Burnham EL, Williams A, Moss M. Post-extubation dysphagia is associated with longer hospitalization in survivors of critical illness with neurologic impairment. Crit Care. 2013 Jun 20;17(3):R119. doi: 10.1186/cc12791.
- Zuercher P, Schenk NV, Moret C, Berger D, Abegglen R, Schefold JC. Risk Factors for Dysphagia in ICU Patients After Invasive Mechanical Ventilation. Chest. 2020 Nov;158(5):1983-1991. doi: 10.1016/j.chest.2020.05.576. Epub 2020 Jun 7.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Dynamics
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