- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01893697
The Influence of Posture on Airway Diameter, Resistance and Airflow Distribution in Healthy Subjects
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Many respiratory diseases require a physiotherapeutic treatment that focusses on clearance of excessive mucus from the airways.
The underlying physiological hypothesis why those mucus clearance techniques are effective is based on the development of an optimal expiratory airflow velocity that applies shearing forces on the mucus at the inner surface of the airway. These shearing forces eventually lead to displacement of mucus to the central airways were it could be evacuated.To accomplish optimal velocity with the same expiratory airflow, it is necessary to decrease the airway diameter and hence increase in the airflow velocity. In other words, the airway diameter and resistance are important factors to take into account in mucus clearance techniques.
In many mucus clearance techniques, postural position is used to facilitate this clearance. Clinical trials in patients with chronic obstructive pulmonary disease (COPD) and cystic fibrosis where they combined clearance techniques with different postural positions showed to be effective.
The influence of posture has been evaluated in the lateral decubitus position and resulted in a greater clearance of mucus in the depended lung. The authors suggested that this may be due to a better deflation of the depended lung that is favored by 3 forces: gravity, mediastinum weight and pressure of abdominal viscera on the infra lateral lung. Deflation of this lung leads not only to a decrease in lung volume, but also results in a decrease in airway diameter. Nevertheless, it is not known to what extend this decrease in diameter occurs in a lateral position. Furthermore, an optimal expiratory flow must be retained in the underlying lung at lower lung volumes. These regional changes in the underlying lung cannot be measured by for example classic lung function tests since these test are not sensitive enough. Indeed, Washko et. al. found no significant changes of overall residual volume (RV), total lung capacity (TLC) and vital capacity (VC) between the different positions in healthy subject.
However, Functional respiratory imaging (FRI) is able to assess the regional changes in healthy subjects. This 3D imaging technique in combination with computational fluid dynamics (CFD) is accurate in calculating regional changes such as airway diameter, volume and resistance. In addition, repetitive FRI measures are able to assess lobar expansion, which is an indirect measure of airflow distribution in a specific part of the lung.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Edegem
-
Antwerp, Edegem, Belgium, 2650
- UZA
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Men or female patients age > 18
- No respiratory disease in the days prior to the enrollment
- Able to perform a lung function tests
- Motivated to participate.
- Written informed consent from the subject prior to the participation
Exclusion Criteria:
- Serious co-morbidity which would interfere with the examinations
- One or multiple CT scans of the chest during the last year.
- Deformities or complications preventing patients to maintain side lying position during the scanning procedure
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Crossover
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Healthy Participants
HRCT scan in a specific postural position
|
HRCT Scan taken in supine and lateral position
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional Respiratory Imaging
Time Frame: 1 study visit (1 day)
|
A low dose 3D spiral high resolution computed tomography (HRCT) scan will be taken on 2 volumes TLC and functional residual capacity (FRC) in both supine and lateral decubitus position.
Image post processing is performed to look at local changes in airway or lobar volume [liter] and airway resistance [kiloPascal.seconds/liter]
distribution in the lung
|
1 study visit (1 day)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Wilfried De Backer, MD PhD, University Hospital, Antwerp
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- RESPT_2013_01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy Participants
-
PfizerRecruitingHealthy Subjects | Healthy ParticipantsUnited States
-
Insmed IncorporatedRecruitingHealthy ParticipantsUnited States
-
Aeovian Pharmaceuticals, Inc.RecruitingHealthy ParticipantsAustralia
-
Suzhou Zelgen Biopharmaceuticals Co.,LtdRecruitingHealthy ParticipantsChina
-
CelgeneNot yet recruitingHealthy ParticipantsUnited States
-
Bristol-Myers SquibbNot yet recruiting
-
AstraZenecaParexelRecruiting
-
ProMis Neurosciences, IncRecruiting
-
Novo Nordisk A/SRecruitingHealthy ParticipantsCanada
-
Novo Nordisk A/SRecruiting
Clinical Trials on HRCT scan in a specific postural position
-
Centre Hospitalier Universitaire de NiceCompletedHematological MalignanciesFrance
-
Anna OlczakCompleted
-
Military Institute of Medicine, PolandCompleted
-
Anna OlczakCompletedStroke, IschemicPoland
-
Anna OlczakCompleted
-
Anna OlczakCompleted
-
Anna OlczakCompleted
-
Central DuPage HospitalCompleted
-
Rinicare LtdUniversity Hospitals of Morecambe Bay NHS TrustUnknownAccidental Fall
-
Peking Union Medical College HospitalRecruiting