NCT04180449

Brief Summary

Retrospective study in intermediate care unit patients on the incidence, Risk factors, and effects on mortality of dysphagia. During a 6-month observational period, routine data will be collected and analysed.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

November 25, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 27, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

February 14, 2020

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

November 12, 2024

Status Verified

November 1, 2024

Enrollment Period

4.7 years

First QC Date

November 25, 2019

Last Update Submit

November 7, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Incidence of positive screening (first screening) for dysphagia in neurosurgical intermediate care unit patients

    incidence: percentage of patients with screening positivity at first screening

    within 8 hours from intermediate care unit admission

Study Arms (2)

Dysphagia screening positive

Other: Screening for dysphagia along clinical routine

Dysphagia screening negative

Other: Screening for dysphagia along clinical routine

Interventions

Screening for dysphagia using the water swallow test in intermediate care unit patients

Dysphagia screening negativeDysphagia screening positive

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Intermediate Care unit patients

You may qualify if:

  • Intermediate care unit patients admitted within the observational period

You may not qualify if:

  • documented refusal to General Consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of Intensive Care Medicine

Bern, Switzerland

Location

Related Publications (2)

  • Zuercher P, Moret CS, Dziewas R, Schefold JC. Dysphagia in the intensive care unit: epidemiology, mechanisms, and clinical management. Crit Care. 2019 Mar 28;23(1):103. doi: 10.1186/s13054-019-2400-2.

    PMID: 30922363BACKGROUND
  • Schefold JC, Berger D, Zurcher P, Lensch M, Perren A, Jakob SM, Parviainen I, Takala J. Dysphagia in Mechanically Ventilated ICU Patients (DYnAMICS): A Prospective Observational Trial. Crit Care Med. 2017 Dec;45(12):2061-2069. doi: 10.1097/CCM.0000000000002765.

    PMID: 29023260BACKGROUND

MeSH Terms

Conditions

Deglutition Disorders

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosisHealth SurveysSurveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesDiagnostic ServicesPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthPublic Health Practice

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2019

First Posted

November 27, 2019

Study Start

February 14, 2020

Primary Completion

November 1, 2024

Study Completion

December 1, 2024

Last Updated

November 12, 2024

Record last verified: 2024-11

Locations