NCT03753841

Brief Summary

Dysphagia is associated with high rates of mortality and morbidity. Adjusting the oral diet of ICU-patients based on flexible endoscopic evaluation of swallowing (FEES) findings might reduce pneumonia rate, mortality and need for intubation/tracheotomy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
125

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable

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

Study Start

First participant enrolled

January 14, 2014

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 3, 2016

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2016

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

November 16, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 27, 2018

Completed
Last Updated

November 27, 2018

Status Verified

November 1, 2018

Enrollment Period

2.6 years

First QC Date

November 16, 2018

Last Update Submit

November 22, 2018

Conditions

DysphagiaAspiration PneumoniaDeglutition DisordersIntensive Care Neurological Disorder

Keywords

DysphagiaAspirationManagement of DysphagiaDeglutition DisordersDeglutitionFEESIntensive Care Neurological Disorder

Outcome Measures

Primary Outcomes (2)

  • Pneumonia Rate

    self-explanatory

    Up to 130 days

  • Mortality

    self-explanatory

    Up to 130 days

Secondary Outcomes (2)

  • Length of stay in hospital

    Up to 130 days

  • Intubation/Tracheotomy

    Up to 130 days

Study Arms (2)

Adjustment of oral diet

ACTIVE COMPARATOR

Patients who need a change in their diet regime, in whom FEES shows that they have not the adequat diet.

Other: Adjustment of oral diet

No adjustment of oral diet

NO INTERVENTION

Patients who have the adequat diet based on FEES findings.

Interventions

Adjustment of oral dietOTHER

Adjustment of oral diet based on findings in fiberendoscopic evaluation of swallowing (FEES)

Adjustment of oral diet

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Treatment on neurological ICU
  • Clinical suspicion of Dysphagia

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsklinikum Gießen

Giessen, Hesse, 35392, Germany

Location

MeSH Terms

Conditions

Deglutition DisordersPneumonia, Aspiration

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic DiseasesPneumoniaRespiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Tobias Braun, M.D.

    University of Giessen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 16, 2018

First Posted

November 27, 2018

Study Start

January 14, 2014

Primary Completion

September 3, 2016

Study Completion

September 16, 2016

Last Updated

November 27, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

The authors declare that the data supporting the findings of this study will be available within the published article(s). The data that support the findings of this study will not be publically available due to local medical data protection policies.

Locations

DE(1)