- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06381973
Ventilation Distribution in COPD Patients During Breathing Exercises
Influence of Airway Clearance Techniques on Ventilation Distribution in the Lateral Posture in COPD and Healthy Individuals
ELTGOL (Slow Expiration with the Opened Glottis in the Lateral posture) is an airway clearance technique performed in the lateral decubitus position. This technique focuses on optimizing ventilation of the infralateral lung (when the subject is lying in the lateral posture) to enhance local air-liquid interaction. Previous studies on ventilation differences between the infra- and supralateral lungs were conducted on healthy, young, male subjects, without the application of thoracic or abdominal pressure.
This study aimed to assess ventilation distribution in right lateral recumbency in patients with chronic obstructive pulmonary disease (COPD), as well as healthy individuals, and investigate the impact of thoracic and abdominal manual pressures during ELTGOL on ventilation distribution.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Brussels Capital
-
Brussels, Brussels Capital, Belgium, 1200
- Cliniques Universitaires Saint-luc
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Healthy subjects: No acute or chronic respiratory disease, normal lung function, non-smoker.
- Patients with COPD: forced expiratory volume at one second (FEV1) ≤ 80% predicted value, in stable state.
Exclusion Criteria:
- Healthy subjects: obesity (BMI > 35kg/m²); active or former smoker; severe scoliosis; cardiovascular or neuromuscular disease; active implant (cardiac pacemaker or an implantable cardioverter-defibrillator (ICD); thoracic skin lesion.
- Patients with COPD: obesity (BMI > 35kg/m²); severe scoliosis; severe cardiovascular disease; neuromuscular disease; active implant (cardiac pacemaker or an implantable cardioverter-defibrillator (ICD); thoracic skin lesion.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: ELTGOL_Physio
ELTGOL + Manual pressure of the physiotherapist
|
The subject will be asked to slowly exhale with the glottis opened in the right lateral posture.
The physiotherapist will accompany the subject by gently applying manual pressure on the chest wall and the abdomen during expiratory phases.
|
|
Active Comparator: ELTGOL_Auto
ELTGOL performed autonomously
|
The subject will be asked to slowly exhale with the glottis opened in the right lateral posture.
The physiotherapist will not intervene in this arm.
|
|
Active Comparator: PEP
Positive expiratory pressure (PEP)
|
The subject will be asked to exhale through a positive expiratory pressure (PEP) device (Threshold PEP) while being in the right lateral posture.
|
|
Active Comparator: 1L-Tidal-Breathing
Tidal-breathing of 1 liter per breath
|
The subject will be asked to breath with a fixed tidal-breathing of 1 liter per breath (monitored via a spirometer) while being in the right lateral posture.
|
|
Active Comparator: Spontaneous Breathing
|
The subject will be asked to breath spontaneously while being in the right lateral posture.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Impedance variation using Electrical Impedance Tomography
Time Frame: 2 minutes during intervention
|
Impedance change in the right and left lungs
|
2 minutes during intervention
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ELTGOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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