NCT02460757

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.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 27, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 2, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Last Updated

December 9, 2015

Status Verified

December 1, 2015

Enrollment Period

1.8 years

First QC Date

May 27, 2015

Last Update Submit

December 8, 2015

Conditions

Lung Diseases

Keywords

glottic movementemphysemacopdvocal cord

Outcome Measures

Primary Outcomes (1)

  • Angle of the glottic width

    18 Months

Study Arms (3)

Patients with COPD

Other: Laryngoscopy

Patients with interstitial lung disease

Other: Laryngoscopy

Healthy subjects

Other: Laryngoscopy

Interventions

LaryngoscopyOTHER

Observation of glottic width in different arms

Healthy subjectsPatients with COPDPatients with interstitial lung disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with various lung diseases in a primary care clinic

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruhrlandklinik

Essen, 45239, Germany

Location

MeSH Terms

Conditions

Lung DiseasesEmphysemaPulmonary Disease, Chronic Obstructive

Interventions

Laryngoscopy

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsLung Diseases, ObstructiveChronic DiseaseDisease Attributes

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeOtorhinolaryngologic Surgical Procedures

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 27, 2015

First Posted

June 2, 2015

Study Start

February 1, 2014

Primary Completion

December 1, 2015

Last Updated

December 9, 2015

Record last verified: 2015-12

Locations

DE(1)