NCT02333201

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2014

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 7, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

March 8, 2016

Status Verified

March 1, 2016

Enrollment Period

6 months

First QC Date

December 22, 2014

Last Update Submit

March 7, 2016

Conditions

Deglutition Disorders

Keywords

Deglutition DisordersDysphagiaMechanical VentilationSepsis

Outcome Measures

Primary Outcomes (1)

  • Number of patients with dysphagia at discharge from ICU

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

Secondary Outcomes (13)

  • 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 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.)

  • 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 re-intubated, reason for re-intubation, and antibiotic use

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

  • +8 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Intensive Care Medicine, University of Bern,

Bern, 3010, Switzerland

Location

Related Publications (3)

  • 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.

    PMID: 20202948BACKGROUND

  • 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.

    PMID: 23786755BACKGROUND

  • 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.

    PMID: 32525018DERIVED

MeSH Terms

Conditions

Deglutition DisordersSepsis

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic DiseasesInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jukka Takala, Prof Dr.

    University of Bern, Inselspital

    STUDY CHAIR

  • Stephan Jakob, Prof. Dr.

    University of Bern, Inselspital

    STUDY CHAIR

  • Joerg C Schefold, MD

    University of Bern, Inselspital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator/ Coordinating Investigator

Study Record Dates

First Submitted

December 22, 2014

First Posted

January 7, 2015

Study Start

April 1, 2015

Primary Completion

October 1, 2015

Study Completion

December 1, 2015

Last Updated

March 8, 2016

Record last verified: 2016-03

Locations

CH(1)