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Deglutition DisordersDYnAMICSNCT02333201

DYsphAgia In Mechanically Ventilated ICU patientS

An observational study of Deglutition Disorders, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Deglutition Disorders
How many people
2,000 participants
Where
1 siteSwitzerland
Study dates
Apr 2015to Dec 2015
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Mixed Population of adult ICU patients (aged 18+) post invasive mechanical ventilation

Who may be able to join

None listed.

Who cannot join

  • patients prone to die / moribund patients/ or dying patients
  • patients post oesophageal resection / with oesophageal rupture

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Dept. of Intensive Care Medicine, University of Bern,

    Bern, 3010

Other trials in Switzerland

About this study

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

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.

Read the 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.

Keywords
Deglutition Disorders, Dysphagia, Mechanical Ventilation, Sepsis
Medical subject headings
Deglutition Disorders, Sepsis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients with dysphagia at discharge from ICU

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

Secondary outcomes (13)

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

    Measured: expected average time frame about 48 hrs.

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

    Measured: 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

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

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

    Measured: 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

    Measured: 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

    Measured: 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.

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2015 (estimated)
  2. Study startApr 2015
  3. Primary completionOct 2015
  4. Study completionDec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Time perspective
Prospective
Enrolment
2,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02333201
Sponsor's protocol ID
Dynamics
Acronym
DYnAMICS
Status last verified
Mar 2016
First submitted
22 Dec 2014
Last updated
8 Mar 2016
Results posted
No

Publications

  • 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.

    PubMed 20202948

  • 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.

    PubMed 23786755

  • 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.

    PubMed 32525018

Questions about this trial

What is this clinical trial studying?

An observational study of Deglutition Disorders, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients with dysphagia at discharge from ICU (time frame: expected average time frame about 72hrs. (at end of ICU stay/ discharge)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02333201, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2016.

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