Dysphagia on the Intensive Care Unit | NCT03487510

Studies
Dysphagia on the Intensive Care Unit

NCT03487510

Sponsor

Insel Gruppe AG, University Hospital Bern

Status

Completed

Last Update Posted

Nov 12, 2024Actual

Enrollment

49Actual

Phase

Not provided

Conditions

Deglutition Disorders

Interventions

NO interventions apply

Countries

Switzerland

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

May 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

Nov 11, 2017Actual

Primary Completion Date

May 1, 2018Actual

Completion Date

May 1, 2018Actual

First Submitted Date

Mar 9, 2018

First Submission Date that Met QC Criteria

Apr 3, 2018

First Posted Date

Apr 4, 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 7, 2024

Last Update Posted Date

Nov 12, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jörg Schefold, Sponsor-investigator, Insel Gruppe AG, University Hospital BernPrincipal Investigator

Lead Sponsor

Insel Gruppe AG, University Hospital BernOTHER

Collaborators

Not provided

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Recording of routine practice patterns to detect and/or treat Dysphagia on the ICU via interview of local colleagues. This will not allow to record generalizable data, but will reflect the actual routine standard of care.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

49Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NO groups		no groups apply.	Other: NO interventions apply

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NO interventions apply	Other	does not apply	NO groups

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of centers using fibre-optic endoscopic evaluation of swallowing (FEES) vs. non-instrumental methods to detect/ treat dysphagia on the ICU.	Analysis of number of ICUs using instrumental methods (FEES) vs. non-instrumental methods in local (Swiss) centers to detect dysphagia in the ICU.	through study completion, an average of 1 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

All senior ICU physicians in charge for adult critically ill ICU patients. Respective ICUs must be accredited by the "Schweizerische Gesellschaft für Intensivmedizin".
ICUs located in Switzerland.
Senior ICU physicians willing to voluntarily fill in the provided questionnaire.

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

Senior local ICU physicians (Swiss ICUs only).

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Patrick Zürcher, MD	Inselspital, University of Bern	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept. of Intensive Care Medicine, University of Bern,		Bern		3010	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003680	Deglutition Disorders

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