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NCT Number: NCT02333201

DYsphAgia In Mechanically Ventilated ICU patientS

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dept. of Intensive Care Medicine, University of Bern,

Bern, 3010, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of patients with dysphagia at discharge from ICU

    Time frame: expected average time frame about 72hrs. (at end of ICU stay/ discharge)

Secondary outcomes

  1. Number of patients with dysphagia and dysphagia severity at first assessment

    Time frame: expected average time frame about 48 hrs.

  2. Number of patients with dysphagia / incl. dysphagia severity at discharge

    Time frame: expected average time frame about 72 hrs. (end of ICU stay)

  3. 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

    Time frame: during ICU stay (expected average length of ICU stay is about 72 hrs.)

  4. Number of patients with dysphagia and (association to) sedatives prescribed

    Time frame: during ICU stay (expected average length of ICU stay is about 72 hrs.)

  5. Number of patients re-intubated, reason for re-intubation, and antibiotic use

    Time frame: during ICU stay (expected average length of ICU stay is about 72 hrs./ observational period)

  6. Number of patients with dysphagia and association to duration of mechanical ventilation

    Time frame: during ICU stay (expected average length of ICU stay is about 72 hrs.)

  7. Number of patients with dysphagia (in association) to tube size, body weight/ BMI etc.

    Time frame: during ICU stay (expected average length of ICU stay is about 72 hrs./ observational period)

  8. Number of patients with dysphagia according to disease severity and routine laboratory indices

    Time frame: during ICU stay (expected average length of ICU stay is about 72 hrs./ observational period)

  9. Duration of dysphagia/ course of dysphagia severity during ICU/ hospital stay

    Time frame: 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)

  10. Number of chest X-ray examinations performed among patients w/ and w/o dysphagia

    Time frame: 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)

  11. Association of dysphagia and related ICU length of stay/ hospital length of stay

    Time frame: during ICU stay (expected average length of ICU stay is about 72 hrs./ observational period)

  12. Association of dysphagia and related ICU- and intrahospital mortality/ readmission rate

    Time frame: during ICU stay (expected average length of ICU stay is about 72 hrs./ observational period)

  13. Other clinical/ epidemiological factors associated with dysphagia (incl. descriptive analyses)

    Time frame: during ICU stay (expected average length of ICU stay is about 72 hrs./ observational period)

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Collaborators

  • Nestec S.A., Switzerland (Funding)

Registry information

Official study title

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

Acronym: DYnAMICS

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jan 7, 2015
Registry last updated
Mar 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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