Clinical Trials Directory

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.