Unspecified Complication of Lung TransplantNCT00584181
High-resolution Computed Tomography (HRCT) Evaluation of Airway Distensibility in Lung Transplant Recipients
An observational study of Unspecified Complication of Lung Transplant, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
Lung and heart-lung recipients at the University of Texas Medical Branch who have participated in the "Assessment of Cough Reflex in Lung Transplant Recipients" study who meet the specific study inclusion/exclusion criteria will have one study visit where they will undergo lung volume measurements, followed by high… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unspecified Complication of Lung Transplant
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to 7 Jan 2018
- 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
- No healthy volunteers
- Adult, Older adult
Study population: All patients who participated in the "Assessment of Cough Reflex in Lung Transplant Recipients" study who meet the specific inclusion/exclusion criteria for this study
Who may be able to join
- lung transplant recipients >18 years of age
- at least 12 months or greater from time of transplantation
Who cannot join
- hemodynamic instability
- hypoxemia
- pneumonia
- moderate or large pleural effusion
- clinical evidence of acute rejection
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Medical Branch
Galveston, Texas, 77555
About this study
Official title: High Resolution Computed Tomographic Evaluation of Airway Distensibility in Lung Transplant Recipients: A Pilot Study
Lung and heart-lung recipients at the University of Texas Medical Branch who have participated in the "Assessment of Cough Reflex in Lung Transplant Recipients" study who meet the specific study inclusion/exclusion criteria will have one study visit where they will undergo lung volume measurements, followed by high resolution CT scan of the lungs within 2 hours. After the initial CT scan, patients will be given a standard dose of Atrovent, followed thirty minutes later by repeat lung volume measurements and CT scan.
Read the detailed description
Chest CT imaging will be obtained in the radiology department at UTMB. After the initial screening visit, subjects will visit the pulmonary function laboratory where they will undergo spirometry and measurement of lung volumes by whole body plethysmography. Within two hours of pulmonary function testing, subjects will undergo an initial HRCT scan. After the initial HRCT, subjects will inhale a standard dose of ipratropium bromide (0.5 mg) using a hand held nebulizer. Thirty minutes after ipratropium bromide administration, spirometry will be measured followed by a second HRCT scan.
Spirometry measurements will be performed in triplicate with the subjects in a seated position using a portable Koko spirometer (PDS, Louisville, CO). After the spirometry measurements, lung volumes will be measured in a body plethysmograph (MedGraphics, St. Paul, MN) with the subjects in a seated position with a nose clip. Subjects will be instructed to pant against the closed shutter at a frequency of 1-3 Hz. Lung volume measurements will be obtained prior to inital chest CT. Subjects will undergo high resolution computed tomography (HRCT) scanning within 30 minutes of initial lung volume measurements.
After the initial HRCT of the chest, subjects will inhale a dose of nebulized ipratropium bromide (0.5 mg) by standard nebulizer after which spirometry and lung volume measurements will be repeated in the pulmonary function laboratory. Spirometry and lung volume measurements will be performed in the same manner. Lung volume measurements will be obtained to account for changes in lung volumes after bronchodilator administration. Changes in lung volumes will be used to account for any changes noted on HRCT scans.
HRCT scanning will begin 6 cm above the top of the dome of the diaphragm, at TLC and moved caudally. Images will be reconstructed with the use of a high-spatial frequency (resolution) algorithm that enhanced edge detection, at a window level of -450 Hounsfield units and a window width of 1,350 Hounsfield units. We will consider the airway diameters after maximum bronchodilation with ipratropium to be a function principally of the structural characteristics of airways. The TLC measurements after ipratropium will be the best reflection of intrinsic structure. CT airway measurement analysis will be performed by VIDA Diagnostics. We have entered into a collaboration with VIDA Diagnostics that will allow accurate and reliable CT airway measurements. Subject's CT images obtained at UTMB will be deidentified and electronically transmitted to a research collaborator at VIDA Diagnostics located in Coralville, IA. The CT images will have a code assigned, known only to the PI. Using a proprietary software platform, airway measurements will be performed and the data electronically transmitted to the PI at UTMB.
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 |
|---|---|---|
| Lung transplant recipients | Lung transplant recpients enrolled as study subjects will undergo pulmonary function tests (spirometry and lung volume measurements) and initial HRCT of chest. These subjects will receive nebulized ipratropium followed by pulmonary function tests (spirometry and lung volume measurements) and repeat HRCT. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spirometry changes
Assessment of changes in spirometry following inhalation of nebulized ipratropium
Measured: Two hours (before and after inhalation of ipratropium)
Secondary outcomes (1)
Lung volumes
Assessment of changes in total lung capacity, functional reserve capacity and inspiratory capacity following inhalation of nebulized ipratropium
Measured: Two hours (before and after inhalation of ipratropium)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2008 (estimated)
- Study startAug 2007
- Primary completion7 Jan 2018
- Study completion7 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unspecified Complication of Lung TransplantStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- 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
- 10 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander G Duarte, MD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00584181
- Sponsor's protocol ID
- 07-247
- Status last verified
- Feb 2018
- First submitted
- 20 Dec 2007
- Last updated
- 22 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Resolution Computed Tomographic Evaluation of Airway Distensibility in Lung Transplant Recipients: A Pilot Study
- ClinicalTrials.gov ID
- NCT00584181
- Acronym / sponsor ID
- 07-247
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- 7 Jan 2018 (actual)
- Study completion
- 7 Jan 2018 (actual)
- First posted
- 2 Jan 2008 (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.
Lung and heart-lung recipients at the University of Texas Medical Branch who have participated in the "Assessment of Cough Reflex in Lung Transplant Recipients" study who meet the specific study inclusion/exclusion criteria will have one study visit where they will undergo lung volume measurements, followed by high resolution CT scan of the lungs within 2 hours. After the initial CT scan, patients will be given a standard dose of Atrovent, followed thirty minutes later by repeat lung volume measurements and CT scan.
Detailed description
Chest CT imaging will be obtained in the radiology department at UTMB. After the initial screening visit, subjects will visit the pulmonary function laboratory where they will undergo spirometry and measurement of lung volumes by whole body plethysmography. Within two hours of pulmonary function testing, subjects will undergo an initial HRCT scan. After the initial HRCT, subjects will inhale a standard dose of ipratropium bromide (0.5 mg) using a hand held nebulizer. Thirty minutes after ipratropium bromide administration, spirometry will be measured followed by a second HRCT scan.
Spirometry measurements will be performed in triplicate with the subjects in a seated position using a portable Koko spirometer (PDS, Louisville, CO). After the spirometry measurements, lung volumes will be measured in a body plethysmograph (MedGraphics, St. Paul, MN) with the subjects in a seated position with a nose clip. Subjects will be instructed to pant against the closed shutter at a frequency of 1-3 Hz. Lung volume measurements will be obtained prior to inital chest CT. Subjects will undergo high resolution computed tomography (HRCT) scanning within 30 minutes of initial lung volume measurements.
After the initial HRCT of the chest, subjects will inhale a dose of nebulized ipratropium bromide (0.5 mg) by standard nebulizer after which spirometry and lung volume measurements will be repeated in the pulmonary function laboratory. Spirometry and lung volume measurements will be performed in the same manner. Lung volume measurements will be obtained to account for changes in lung volumes after bronchodilator administration. Changes in lung volumes will be used to account for any changes noted on HRCT scans.
HRCT scanning will begin 6 cm above the top of the dome of the diaphragm, at TLC and moved caudally. Images will be reconstructed with the use of a high-spatial frequency (resolution) algorithm that enhanced edge detection, at a window level of -450 Hounsfield units and a window width of 1,350 Hounsfield units. We will consider the airway diameters after maximum bronchodilation with ipratropium to be a function principally of the structural characteristics of airways. The TLC measurements after ipratropium will be the best reflection of intrinsic structure. CT airway measurement analysis will be performed by VIDA Diagnostics. We have entered into a collaboration with VIDA Diagnostics that will allow accurate and reliable CT airway measurements. Subject's CT images obtained at UTMB will be deidentified and electronically transmitted to a research collaborator at VIDA Diagnostics located in Coralville, IA. The CT images will have a code assigned, known only to the PI. Using a proprietary software platform, airway measurements will be performed and the data electronically transmitted to the PI at UTMB.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung transplant recipients | – | –Lung transplant recpients enrolled as study subjects will undergo pulmonary function tests (spirometry and lung volume measurements) and initial HRCT of chest. These subjects will receive nebulized ipratropium followed by pulmonary function tests (spirometry and lung volume measurements) and repeat HRCT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who participated in the "Assessment of Cough Reflex in Lung Transplant Recipients" study who meet the specific inclusion/exclusion criteria for this study
Key inclusion criteria (2 listed)
- lung transplant recipients >18 years of age
- at least 12 months or greater from time of transplantation
Key exclusion criteria (5 listed)
- hemodynamic instability
- hypoxemia
- pneumonia
- moderate or large pleural effusion
- clinical evidence of acute rejection
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
Spirometry changes
Time frame: Two hours (before and after inhalation of ipratropium)
Assessment of changes in spirometry following inhalation of nebulized ipratropium
1 secondary outcome
Lung volumes
Time frame: Two hours (before and after inhalation of ipratropium)
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 22 Feb 2018.
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.
Alexander G Duarte, MD principal investigator
University of Texas
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 Unspecified Complication of Lung Transplant, run by The University of Texas Medical Branch, Galveston 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 5 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 22 Feb 2018. 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.
What does the primary outcome measure?
Spirometry changes (time frame: Two hours (before and after inhalation of ipratropium)). 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 22 Feb 2018.