DYsphAgia In Mechanically Ventilated ICU patientS

Deglutition Disorders Clinical Trial

— DYnAMICS  

Official title:

DYsphAgia In Mechanically Ventilated ICU patientS (DYnAMICS) - a Prospective Multicentre Observational Analysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02333201
• Other study ID #: Dynamics
• Status: Completed
• Phase: N/A
• First received: December 22, 2014
• Last updated: March 7, 2016
• Start date: April 2015
• Est. completion date: December 2015

Study information

• Verified date: March 2016
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkomission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: December 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Deglutition Disorders

Locations

Country	Name	City	State
Switzerland	Dept. of Intensive Care Medicine, University of Bern,	Bern

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne	Nestec S.A., Switzerland (Funding)

Country where clinical trial is conducted

Switzerland, 

References & Publications (2)

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with dysphagia at discharge from ICU		expected average time frame about 72hrs. (at end of ICU stay/ discharge)	No
Secondary	Number of patients with dysphagia and dysphagia severity at first assessment		expected average time frame about 48 hrs.	No
Secondary	Number of patients with dysphagia / incl. dysphagia severity at discharge		expected average time frame about 72 hrs. (end of ICU stay)	No
Secondary	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.)	No
Secondary	Number of patients with dysphagia and (association to) sedatives prescribed		during ICU stay (expected average length of ICU stay is about 72 hrs.)	No
Secondary	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)	No
Secondary	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.)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No