TracheomalaciaNCT00536315
Tracheal Mechanics During Bronchoscopy
An observational study of Tracheomalacia and Tracheobronchomalacia, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
The main purpose of this study is use a new type of measurement to help decide what kind of therapy would help people with a collapsing windpipe or tracheomalacia. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tracheomalacia, Tracheobronchomalacia
- How many people
- 145 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 1999to Jun 2009
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy control subjects recruited from subjects volunteering for CT or bronchoscopic studies and patients referred for evaluation of possible tracheomalacia.
Who may be able to join
- Suspicion of tracheal collapse undergoing bronchoscopy
- Healthy control subject undergoing bronchoscopy for another purpose.
Who cannot join
- Esophageal pathology
- Tracheostomy
- inability to follow commands
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
The main purpose of this study is use a new type of measurement to help decide what kind of therapy would help people with a collapsing windpipe or tracheomalacia.
Read the detailed description
This study is to obtain new information about the pressures required to collapse the trachea in patients with and without obstructive pulmonary disease and to describe the relationship between pressures and airflow obstruction. This information will provide normative data not currently available and would establish whether tracheal collapse is due to tracheomalacia. The data may lead to better ways of predicting if a patient would benefit from procedures to prevent tracheal collapse.
- Conditions
- Tracheomalacia, Tracheobronchomalacia
- Keywords
- COPD
- Medical subject headings
- Tracheomalacia, Tracheobronchomalacia, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| COPD | Patients with cough and/or shortness of breath who may have windpipe collapse. | |
| Healthy adults | Subjects without symptoms for comparison. | |
| Tracheomalacia | Patients with cough and/or shortness of breath who may have windpipe collapse. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2007 (estimated)
- Study start1 Mar 1999
- Primary completionJul 2008
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TracheomalaciaStudies 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
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen Loring, Beth Israel Deaconess Medical Center
- Investigators
- Stephen H Loring, M.D., Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00536315
- Sponsor's protocol ID
- 2001P001418
- Status last verified
- Feb 2010
- First submitted
- 26 Sep 2007
- Last updated
- 10 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Loring SH, O'donnell CR, Feller-Kopman DJ, Ernst A. Central airway mechanics and flow limitation in acquired tracheobronchomalacia. Chest. 2007 Apr;131(4):1118-24. doi: 10.1378/chest.06-2556.
PubMed 17426218
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tracheal Mechanics During Bronchoscopy
- ClinicalTrials.gov ID
- NCT00536315
- Acronym / sponsor ID
- 2001P001418
- Conditions
- Tracheomalacia, Tracheobronchomalacia
- Keywords
- COPD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- 1 Mar 1999 (actual)
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 27 Sep 2007 (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.
The main purpose of this study is use a new type of measurement to help decide what kind of therapy would help people with a collapsing windpipe or tracheomalacia.
Detailed description
This study is to obtain new information about the pressures required to collapse the trachea in patients with and without obstructive pulmonary disease and to describe the relationship between pressures and airflow obstruction. This information will provide normative data not currently available and would establish whether tracheal collapse is due to tracheomalacia. The data may lead to better ways of predicting if a patient would benefit from procedures to prevent tracheal collapse.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| COPD | – | –Patients with cough and/or shortness of breath who may have windpipe collapse. |
| Healthy adults | – | –Subjects without symptoms for comparison. |
| Tracheomalacia | – | –Patients with cough and/or shortness of breath who may have windpipe collapse. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy control subjects recruited from subjects volunteering for CT or bronchoscopic studies and patients referred for evaluation of possible tracheomalacia.
Key inclusion criteria (2 listed)
- Suspicion of tracheal collapse undergoing bronchoscopy
- Healthy control subject undergoing bronchoscopy for another purpose.
Key exclusion criteria (3 listed)
- Esophageal pathology
- Tracheostomy
- inability to follow commands
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 10 Mar 2017.
- Results publication: PubMed 17426218Loring SH, O'donnell CR, Feller-Kopman DJ, Ernst A. Central airway mechanics and flow limitation in acquired tracheobronchomalacia. Chest. 2007 Apr;131(4):1118-24. doi: 10.1378/chest.06-2556.
Related trials for Tracheomalacia
Enrolling by invitation
Feasibility of Tracheobronchial Reconstruction Using Allogenic Aortic Patch in Children
Trachea Diseases, Tracheal Stenosis
Enrolling by invitation
Primary Posterior Tracheopexy Prevents Tracheal Collapse
Oesophageal Atresia With Tracheo-Oesophageal Fistula, Tracheomalacia
Not yet recruitingPhase 3
Enhancing Lung Health in Kids With Structural Lung Damage and Malformations: Azithromycin (AZI) for Airway Infection Prevention
Tracheomalacia, Bronchopulmonary Dysplasia (BPD)
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.
Stephen H Loring, M.D. principal investigator
Beth Israel Deaconess Medical Center
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 Tracheomalacia and Tracheobronchomalacia, run by Beth Israel Deaconess Medical Center at 1 site in United States.
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 2 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 10 Mar 2017. 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 United States. 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?
On the ClinicalTrials.gov record for NCT00536315, which also lists 1 linked publication.
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 10 Mar 2017.