FEES to Determine Neurological Intensive Care Patients' O... | NCT03753841

Studies
FEES to Determine Neurological Intensive Care Patients' Oral Diet

NCT03753841

Sponsor

University of Giessen

Status

Completed

Last Update Posted

Nov 27, 2018Actual

Enrollment

125Actual

Phase

Not Applicable

Conditions

Dysphagia
Aspiration Pneumonia
Deglutition Disorders
Intensive Care Neurological Disorder

Interventions

Adjustment of oral diet

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 14, 2014Actual

Primary Completion Date

Sep 3, 2016Actual

Completion Date

Sep 16, 2016Actual

First Submitted Date

Nov 16, 2018

First Submission Date that Met QC Criteria

Nov 22, 2018

First Posted Date

Nov 27, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 22, 2018

Last Update Posted Date

Nov 27, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Dysphagia, a common complication in neurological disorders, leads to high rates of mortality and morbidity. It is prevalent in critically ill patients, especially those who need mechanical ventilation. The investigators therefore investigate the effect of adjusting the oral diet of our intensive care unit (ICU) patients based on flexible endoscopic evaluation of swallowing (FEES) findings, thereby assessing the impact of FEES on a neurological ICU. All patients treated on the investigators neurological ICU will be eligible for this study.

The investigators will correlate findings with baseline data, disability status, pneumonia and duration of hospitalisation, as well as a need for mechanical ventilation or a tracheotomy.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

125Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Adjustment of oral diet	Other	Adjustment of oral diet based on findings in fiberendoscopic evaluation of swallowing (FEES)	Adjustment of oral diet

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pneumonia Rate	self-explanatory	Up to 130 days
Mortality	self-explanatory	Up to 130 days

Secondary Outcomes

Measure	Description	Time Frame
Length of stay in hospital	self-explanatory	Up to 130 days
Intubation/Tracheotomy	Rate of Intubation/Tracheotomy	Up to 130 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Treatment on neurological ICU
Clinical suspicion of Dysphagia

Exclusion Criteria:

none

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tobias Braun, M.D.	University of Giessen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universitätsklinikum Gießen		Giessen	Hesse	35392	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

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.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003680	Deglutition Disorders
D011015	Pneumonia, Aspiration

Ancestor Terms

ID	Term
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D010608	Pharyngeal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided