Clinical trial NCT02333201: DYsphAgia In Mechanically Ventilated ICU patientS
Official title: DYsphAgia In Mechanically Ventilated ICU patientS (DYnAMICS) - a Prospective Multicentre Observational Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Deglutition Disorders
Keywords: Deglutition Disorders
Dysphagia
Mechanical Ventilation
Sepsis
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: Nestec S.A., Switzerland (Funding)
First posted: 2015-01-07
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Mixed Population of adult ICU patients (aged 18+) post invasive mechanical ventilation

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients with dysphagia at discharge from ICU
timeFrame: expected average time frame about 72hrs. (at end of ICU stay/ discharge)
Secondary outcomes:
measure: Number of patients with dysphagia and dysphagia severity at first assessment
timeFrame: expected average time frame about 48 hrs.
measure: Number of patients with dysphagia / incl. dysphagia severity at discharge
timeFrame: expected average time frame about 72 hrs. (end of ICU stay)
measure: 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
timeFrame: during ICU stay (expected average length of ICU stay is about 72 hrs.)
measure: Number of patients with dysphagia and (association to) sedatives prescribed
timeFrame: during ICU stay (expected average length of ICU stay is about 72 hrs.)
measure: Number of patients re-intubated, reason for re-intubation, and antibiotic use
timeFrame: during ICU stay (expected average length of ICU stay is about 72 hrs./ observational period)
measure: Number of patients with dysphagia and association to duration of mechanical ventilation
timeFrame: during ICU stay (expected average length of ICU stay is about 72 hrs.)
measure: Number of patients with dysphagia (in association) to tube size, body weight/ BMI etc.
timeFrame: during ICU stay (expected average length of ICU stay is about 72 hrs./ observational period)
measure: Number of patients with dysphagia according to disease severity and routine laboratory indices
timeFrame: during ICU stay (expected average length of ICU stay is about 72 hrs./ observational period)
measure: Duration of dysphagia/ course of dysphagia severity during ICU/ hospital stay
timeFrame: 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)
measure: Number of chest X-ray examinations performed among patients w/ and w/o dysphagia
timeFrame: 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)
measure: Association of dysphagia and related ICU length of stay/ hospital length of stay
timeFrame: during ICU stay (expected average length of ICU stay is about 72 hrs./ observational period)
measure: Association of dysphagia and related ICU- and intrahospital mortality/ readmission rate
timeFrame: during ICU stay (expected average length of ICU stay is about 72 hrs./ observational period)
measure: Other clinical/ epidemiological factors associated with dysphagia (incl. descriptive analyses)
timeFrame: during ICU stay (expected average length of ICU stay is about 72 hrs./ observational period)
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Dept. of Intensive Care Medicine, University of Bern,
Study officials:
affiliation: University of Bern, Inselspital
name: Jukka Takala, Prof Dr.
role: STUDY_CHAIR
affiliation: University of Bern, Inselspital
name: Stephan Jakob, Prof. Dr.
role: STUDY_CHAIR
affiliation: University of Bern, Inselspital
name: Joerg C Schefold, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
citation: 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.