TracheobronchomalaciaPDTONCT01679808
Pressure Dependent Tracheal Obstruction in Copd Patients
An observational study of Tracheobronchomalacia, run by LHL Helse at 1 site in Norway.
Trial summary
Background. Do pressure dependent tracheal obstructions (PDTO) often seen during bronchoscopy in COPD patients affect pulmonary function tests and breathing symptoms? Method. Model study. A garden hose was compressed from one side to simulate the posterior wall of the trachea bulging into the lumen. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tracheobronchomalacia
- How many people
- 104 participants
- Where
- 1 siteNorway
- Study dates
- Aug 2004to Aug 2011
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients (both sexes) in a pulmonary rehabilitation clinic
Who may be able to join
- copd
Who cannot join
- clinical evidence of malignant disease
- not able to be subjected to bronchoscopy
Trial locations and contacts
1 site in 1 country.
About this study
Background. Do pressure dependent tracheal obstructions (PDTO) often seen during bronchoscopy in COPD patients affect pulmonary function tests and breathing symptoms? Method. Model study. A garden hose was compressed from one side to simulate the posterior wall of the trachea bulging into the lumen. For two obstruction lengths - 3 cm and 12 cm, the hose was increasingly compressed in eight steps. Resistance was measured at each step for airflows 1 l/s through 9 l/s, and digital photos of the luminal area were taken which were used by a computer to estimate the cross sectional area reduction and the corresponding distance between the bulging (posterior)and the opposite (anterior) wall (AP-distance).
Patient study. 104 stable COPD patients studied by pulmonary function tests and bronchoscopy. The tracheal obstruction was observed during forced expiration and cough, and the cross sectional area reduction was estimated using the results from the model study.
- Conditions
- Tracheobronchomalacia
- Keywords
- copd, airway obstruction, Tracheobronchomalacia
- Medical subject headings
- Tracheobronchomalacia, Pulmonary Disease, Chronic Obstructive, Airway Obstruction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2012 (estimated)
- Study startAug 2004
- Primary completionAug 2006
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TracheobronchomalaciaStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- LHL Helse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ivar Ellingsen, Dr med, Principal investigator, LHL Helse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01679808
- Sponsor's protocol ID
- GK-18
- Other IDs
- s-04058c
- Acronym
- PDTO
- Status last verified
- Sep 2012
- First submitted
- 3 Sep 2012
- Last updated
- 6 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pressure Dependent Tracheal Obstruction in Copd Patients
- ClinicalTrials.gov ID
- NCT01679808
- Acronym / sponsor ID
- PDTO / GK-18
- Conditions
- Tracheobronchomalacia
- Keywords
- copd, airway obstruction, Tracheobronchomalacia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- LHL HelseUniversity, hospital or other
- Study start
- Aug 2004
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 6 Sep 2012 (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.
Background. Do pressure dependent tracheal obstructions (PDTO) often seen during bronchoscopy in COPD patients affect pulmonary function tests and breathing symptoms? Method. Model study. A garden hose was compressed from one side to simulate the posterior wall of the trachea bulging into the lumen. For two obstruction lengths - 3 cm and 12 cm, the hose was increasingly compressed in eight steps. Resistance was measured at each step for airflows 1 l/s through 9 l/s, and digital photos of the luminal area were taken which were used by a computer to estimate the cross sectional area reduction and the corresponding distance between the bulging (posterior)and the opposite (anterior) wall (AP-distance).
Patient study. 104 stable COPD patients studied by pulmonary function tests and bronchoscopy. The tracheal obstruction was observed during forced expiration and cough, and the cross sectional area reduction was estimated using the results from the model study.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients (both sexes) in a pulmonary rehabilitation clinic
Key inclusion criteria (1 listed)
- copd
Key exclusion criteria (2 listed)
- clinical evidence of malignant disease
- not able to be subjected to bronchoscopy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 6 Sep 2012.
Related trials for Tracheobronchomalacia
Not yet recruitingObservational study
Laryngotracheal Lesions in Adults With Long-Term Tracheostomy
Laryngotracheal Lesions, Tracheostomy Complications
Enrolling by invitation
Feasibility of Tracheobronchial Reconstruction Using Allogenic Aortic Patch in Children
Trachea Diseases, Tracheal Stenosis
Recruiting
Effect of CPAP on 6-Minute Walk Test Outcomes in Patients With ECAC
Tracheobronchomalacia, Excessive Dynamic Airway Collapse
Recruiting
Bioresorbable Airway Splint Pivotal Clinical Trial
Tracheobronchomalacia
Enrolling by invitation
Primary Posterior Tracheopexy Prevents Tracheal Collapse
Oesophageal Atresia With Tracheo-Oesophageal Fistula, Tracheomalacia
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.
Ivar Ellingsen, Dr med principal investigator
LHL Helse
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 Tracheobronchomalacia, run by LHL Helse at 1 site in Norway.
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 1 inclusion and 2 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 6 Sep 2012. 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 Norway. 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.
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 6 Sep 2012.