Trials / Completed
CompletedNCT02333201
DYsphAgia In Mechanically Ventilated ICU patientS
DYsphAgia In Mechanically Ventilated ICU patientS (DYnAMICS) - a Prospective Multicentre Observational Analysis
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 2,000 (actual)
- Sponsor
- Insel Gruppe AG, University Hospital Bern · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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, the investigators 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.
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.
Conditions
Timeline
- Start date
- 2015-04-01
- Primary completion
- 2015-10-01
- Completion
- 2015-12-01
- First posted
- 2015-01-07
- Last updated
- 2016-03-08
Locations
1 site across 1 country: Switzerland
Source: ClinicalTrials.gov record NCT02333201. Inclusion in this directory is not an endorsement.