Lung DiseasesNCT02460757
Glottic Width and Respiratory Flow in Patients With Various Lung Diseases
An observational study of Lung Diseases, run by University Hospital, Essen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Diseases
- What is being tested?
- Laryngoscopy
- How many people
- 56 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2014to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with various lung diseases in a primary care clinic
Who may be able to join
- Clinical indication for a bronchoscopy
- Minimum age of 18 years
- Signed informed consent
Who cannot join
- Patients requiring mechanical ventilation during bronchoscopy
- Disease of the larynx
- Inability to breathe through the mouthpiece
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Lung Diseases
- Being tested
- Laryngoscopy
- Keywords
- glottic movement, emphysema, copd, vocal cord
- Medical subject headings
- Lung Diseases, Emphysema, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaryngoscopyOther
Observation of glottic width in different arms
| Study group | Role | What they receive |
|---|---|---|
| Patients with COPD | Not described Receives: Other: Laryngoscopy | |
| Patients with interstitial lung disease | Not described Receives: Other: Laryngoscopy | |
| Healthy subjects | Not described Receives: Other: Laryngoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Angle of the glottic width
Measured: 18 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2015 (estimated)
- Study startFeb 2014
- Primary completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jane Winantea, University Hospital, Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02460757
- Sponsor's protocol ID
- RLKEssenVC
- Status last verified
- Dec 2015
- First submitted
- 27 May 2015
- Last updated
- 9 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glottic Width and Respiratory Flow in Patients With Various Lung Diseases
- ClinicalTrials.gov ID
- NCT02460757
- Acronym / sponsor ID
- RLKEssenVC
- Conditions
- Lung Diseases
- Keywords
- glottic movement, emphysema, copd, vocal cord
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University Hospital, EssenUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Dec 2015 (actual)
- First posted
- 2 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with COPD | – | Other: Laryngoscopy |
| Patients with interstitial lung disease | – | Other: Laryngoscopy |
| Healthy subjects | – | Other: Laryngoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with various lung diseases in a primary care clinic
Key inclusion criteria (3 listed)
- Clinical indication for a bronchoscopy
- Minimum age of 18 years
- Signed informed consent
Key exclusion criteria (3 listed)
- Patients requiring mechanical ventilation during bronchoscopy
- Disease of the larynx
- Inability to breathe through the mouthpiece
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LaryngoscopyObservation of glottic width in different arms | Other | Healthy subjects, Patients with COPD, Patients with interstitial lung disease |
Primary outcome
Angle of the glottic width
Time frame: 18 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Diseases, run by University Hospital, Essen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Angle of the glottic width (time frame: 18 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2015.