Glottic Width and Respiratory Flow in Patients With Vario... | NCT02460757

Studies
Glottic Width and Respiratory Flow in Patients With Various Lung Diseases

NCT02460757

Sponsor

University Hospital, Essen

Status

Completed

Last Update Posted

Dec 9, 2015Estimated

Enrollment

56Actual

Phase

Not provided

Conditions

Lung Diseases

Interventions

Laryngoscopy

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

Dec 2015

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

Feb 2014

Primary Completion Date

Dec 2015Actual

Completion Date

Not provided

First Submitted Date

May 27, 2015

First Submission Date that Met QC Criteria

Jun 1, 2015

First Posted Date

Jun 2, 2015Estimated

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

Dec 8, 2015

Last Update Posted Date

Dec 9, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

In this study the investigators examine the glottic width and the respiratory flow at rest in patients with various lung disease. The investigators postulated that a positive expiratory pressure is created through the narrowing of the glottic width in patients with hyperinflation.

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

56Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with COPD			Other: Laryngoscopy
Patients with interstitial lung disease			Other: Laryngoscopy
Healthy subjects			Other: Laryngoscopy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Laryngoscopy	Other	Observation of glottic width in different arms	Healthy subjects Patients with COPD Patients with interstitial lung disease

Measure	Description	Time Frame
Angle of the glottic width		18 Months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical indication for a bronchoscopy
Minimum age of 18 years
Signed informed consent

Exclusion Criteria:

Patients requiring mechanical ventilation during bronchoscopy
Disease of the larynx
Inability to breathe through the mouthpiece

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with various lung diseases in a primary care clinic

Sampling Method

Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Ruhrlandklinik		Essen		45239	Germany

Condition Browse Module

MeSH Terms

ID	Term
D008171	Lung Diseases
D004646	Emphysema
D029424	Pulmonary Disease, Chronic Obstructive

Ancestor Terms

ID	Term
D012140	Respiratory Tract Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D008173	Lung Diseases, Obstructive

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007828	Laryngoscopy

Ancestor Terms

ID	Term
D003948	Diagnostic Techniques, Respiratory System
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D004724	Endoscopy

Browse Leaves

Not provided

Browse Branches

Not provided