DYsphAgia In Mechanically Ventilated ICU patientS

Completed

• Conditions: Deglutition Disorders

• Registration Number: NCT02333201
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

Brief 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.

Study Timeline

• Study First Submitted: 2014-12-22
• Study First Submitted QC: 2015-01-05
• Study First Posted: 2015-01-07
• Study Start: 2015-04
• Primary Completion: 2015-10
• Study Completion: 2015-12
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-07
• Last Update Posted: 2016-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients with dysphagia at discharge from ICU	expected average time frame about 72hrs. (at end of ICU stay/ discharge)

Secondary Outcome Measures

Name	Time	Method
Number of patients with dysphagia and (association to) sedatives prescribed	during ICU stay (expected average length of ICU stay is about 72 hrs.)
Number of patients with dysphagia according to disease severity and routine laboratory indices	during ICU stay (expected average length of ICU stay is about 72 hrs./ observational period)
Duration of dysphagia/ course of dysphagia severity during ICU/ hospital stay	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)
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	during ICU stay (expected average length of ICU stay is about 72 hrs.)
Other clinical/ epidemiological factors associated with dysphagia (incl. descriptive analyses)	during ICU stay (expected average length of ICU stay is about 72 hrs./ observational period)
Number of patients re-intubated, reason for re-intubation, and antibiotic use	during ICU stay (expected average length of ICU stay is about 72 hrs./ observational period)
Number of patients with dysphagia and association to duration of mechanical ventilation	during ICU stay (expected average length of ICU stay is about 72 hrs.)
Number of patients with dysphagia and dysphagia severity at first assessment	expected average time frame about 48 hrs.
Number of patients with dysphagia / incl. dysphagia severity at discharge	expected average time frame about 72 hrs. (end of ICU stay)
Number of patients with dysphagia (in association) to tube size, body weight/ BMI etc.	during ICU stay (expected average length of ICU stay is about 72 hrs./ observational period)
Number of chest X-ray examinations performed among patients w/ and w/o dysphagia	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)
Association of dysphagia and related ICU- and intrahospital mortality/ readmission rate	during ICU stay (expected average length of ICU stay is about 72 hrs./ observational period)
Association of dysphagia and related ICU length of stay/ hospital length of stay	during ICU stay (expected average length of ICU stay is about 72 hrs./ observational period)

Trial Locations

Locations (1)

Dept. of Intensive Care Medicine, University of Bern,; 🇨🇭 Bern, Switzerland