- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04663698
The Effect of Volitional Pursed-lips Breathing (PLB)
September 13, 2021 updated by: Karl Josef Franke, PD DR med
Evaluation of PLB Physiology in COPD - Untersuchung Zur Physiologie Der Lippenbremse Bei COPD
Simulation of pursed-lips breathing by defined stenoses in pulmonary function diagnostics to quantify the effect of the pursed-lips breathing
Study Overview
Status
Completed
Conditions
Detailed Description
Since many years it is recommended for COPD patients to reduce the crossdiameter of the lips in order to improve the exhalation by means of so-called pursed-lips breathing (PLB).
But the effects have never been studied quantitatively.
In this study, the PLB effect is simulated during lung function diagnostics, using different sized resistors inserted into the routine mouthpiece of the flow sensor to resemble the effective airway resistances of a PLB maneuver.
This prospective, randomized study includes 20 healthy subjects and 50 COPD patients, who will perform lung function testing with 4 different sized resistors.
Study Type
Interventional
Enrollment (Actual)
110
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
NRW
-
Lüdenscheid, NRW, Germany, 58515
- Märkische Kliniken GmbH, Klinikum Lüdenscheid
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
Patients:
- COPD (GOLD I- IV)
- Stable respiratory situation that allows routine lung funtion
- capable of communication
Healthy:
- Lung Healthy
- capable of communication
Exclusion Criteria:
- Invasive Ventilation
- Other serious acute physical illnesses that require immediate intensive medical treatment
- Acute hypercapnic decompensation with a pH < 7.35 in the capillary BGA
- Pregnancy or Nursing
- Not able to give consent
- Not willing or able to follow the study protocol
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Healthy
Lung-healthy subjects, randomized lung function testing
|
Lung function testing with MasterScreen™ Body, CareFusion Germany GmbH
Lung funtion testing with MasterScreen™ Body, CareFusion Germany GmbH, Mouthpiece with mesh-resistor (5hPa/L) to create laminar airflow
Other Names:
Lung funtion testing with MasterScreen™ Body, CareFusion Germany GmbH, Mouthpiece with mesh-resistor (10hPa/L) to create laminar airflow
Other Names:
Lung function testing with MasterScreen™ Body, CareFusion Germany GmbH, Mouthpiece with perforated resistor (inside diameter 7mm) to create a turbulent airflow
Other Names:
Lung function testing with MasterScreen™ Body, CareFusion Germany GmbH, Mouthpiece with perforated resistor (inside diameter 11mm) to create a turbulent airflow
Other Names:
|
EXPERIMENTAL: Patient 1
COPD patients, randomized lung function testing
|
Lung function testing with MasterScreen™ Body, CareFusion Germany GmbH
Lung funtion testing with MasterScreen™ Body, CareFusion Germany GmbH, Mouthpiece with mesh-resistor (5hPa/L) to create laminar airflow
Other Names:
Lung funtion testing with MasterScreen™ Body, CareFusion Germany GmbH, Mouthpiece with mesh-resistor (10hPa/L) to create laminar airflow
Other Names:
|
EXPERIMENTAL: Patient 2
COPD patients, randomized lung function testing
|
Lung function testing with MasterScreen™ Body, CareFusion Germany GmbH
Lung function testing with MasterScreen™ Body, CareFusion Germany GmbH, Mouthpiece with perforated resistor (inside diameter 7mm) to create a turbulent airflow
Other Names:
Lung function testing with MasterScreen™ Body, CareFusion Germany GmbH, Mouthpiece with perforated resistor (inside diameter 11mm) to create a turbulent airflow
Other Names:
|
EXPERIMENTAL: Patient 3
COPD patients, randomized lung function testing
|
Lung function testing with MasterScreen™ Body, CareFusion Germany GmbH
Lung funtion testing with MasterScreen™ Body, CareFusion Germany GmbH, Mouthpiece with mesh-resistor (5hPa/L) to create laminar airflow
Other Names:
Lung function testing with MasterScreen™ Body, CareFusion Germany GmbH, Mouthpiece with perforated resistor (inside diameter 7mm) to create a turbulent airflow
Other Names:
|
EXPERIMENTAL: Patient 4
COPD patients, randomized lung function testing
|
Lung function testing with MasterScreen™ Body, CareFusion Germany GmbH
Lung funtion testing with MasterScreen™ Body, CareFusion Germany GmbH, Mouthpiece with mesh-resistor (5hPa/L) to create laminar airflow
Other Names:
Lung function testing with MasterScreen™ Body, CareFusion Germany GmbH, Mouthpiece with perforated resistor (inside diameter 11mm) to create a turbulent airflow
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lung function parameter FEV1
Time Frame: up to 1 hour
|
Measuring of lung function parameters with different resistors to simulate PLB unit: L, measured with der MasterScreen™ Body, CareFusion
|
up to 1 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PEF - expiratory Peak Flow
Time Frame: up to 1 hour
|
unit: L, measured with der MasterScreen™ Body, CareFusion
|
up to 1 hour
|
RV%TLC
Time Frame: up to 1 hour
|
unit: %, measured with der MasterScreen™ Body, CareFusion
|
up to 1 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 11, 2019
Primary Completion (ACTUAL)
January 8, 2021
Study Completion (ACTUAL)
March 30, 2021
Study Registration Dates
First Submitted
October 22, 2020
First Submitted That Met QC Criteria
December 10, 2020
First Posted (ACTUAL)
December 11, 2020
Study Record Updates
Last Update Posted (ACTUAL)
September 14, 2021
Last Update Submitted That Met QC Criteria
September 13, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PLB2019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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 COPD
-
University Medical Center GroningenCompleted
-
Istituto Nazionale di Ricovero e Cura per AnzianiRecruiting
-
Bio-Sensing Solutions S.L. (DyCare)Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau; Centre...Not yet recruiting
-
Sir Run Run Shaw HospitalRecruiting
-
University Hospital, BrestRecruiting
-
The First Affiliated Hospital of Guangzhou Medical...Recruiting
-
Association des Réseaux BronchioliteLaboratoire Système et Matériaux pour la Mécatronique (SYMME)Recruiting
-
Baylor Research InstituteNot yet recruiting
-
Polytechnic Institute of PortoNippon Gases PortugalRecruiting
Clinical Trials on Baseline
-
University Hospital Inselspital, BerneCompletedBreast CancerSwitzerland
-
Medical College of WisconsinNational Institute of Mental Health (NIMH)CompletedHIV Prevention and Assessment ReactivitySouth Africa
-
Eisai Inc.CompletedThrombocytopenia Associated With Liver DiseaseUnited States, China, Spain, Argentina, Belgium, Israel, Mexico, Romania, Japan, Brazil, Russian Federation, Germany, Italy, Czechia, Canada, Australia, France
-
Hopital FochCompleted
-
Eisai Inc.CompletedTreatment of Thrombocytopenia in Patients With Chronic Liver DiseaseUndergoing an Elective ProcedureThrombocytopenia Associated With Liver DiseaseUnited States, Italy, China, Taiwan, Spain, Belgium, Poland, Portugal, Canada, Korea, Republic of, Australia, Brazil, Chile, Austria, Germany, Hungary, France, Argentina, United Kingdom, Thailand
-
Lokman Hekim ÜniversitesiHacettepe UniversityCompletedQuality of Life | Lower Urinary Tract Symptoms | Muscle Weakness | Duchenne Muscular Dystrophy | Pelvic Floor Muscle Weakness | Posture Disorders in Children | Lumbar LordosisTurkey
-
Orthocare Innovations, LLCNational Institute on Disability, Independent Living, and Rehabilitation...Terminated
-
Riphah International UniversityCompletedCerebral PalsyPakistan
-
Fondation Ophtalmologique Adolphe de RothschildNot yet recruitingDescribe Ultrasound Matches and Disagreements Ocular and MRI
-
University of WinchesterUniversity College DublinCompletedStroke | Physical Activity | Gait, HemiplegicUnited Kingdom