The Effect of Volitional Pursed-lips Breathing

Study Overview
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Brief Summary
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Simulation of pursed-lips breathing by defined stenoses in pulmonary function diagnostics to quantify the effect of the pursed-lips breathing

Detailed Description
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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.

Official Title
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Evaluation of PLB Physiology in COPD - Untersuchung Zur Physiologie Der Lippenbremse Bei COPD

Conditions
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COPD

Intervention / Treatment
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* Other: Baseline
* Other: MESH-Resistor 5
* Other: MESH-Resistor 10
* Other: Perforated Resistor 7
* Other: Perforated Resistor 11


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy<br>Lung-healthy subjects, randomized lung function testing | Other: Baseline<br>* Lung function testing with MasterScreen™ Body, CareFusion Germany GmbH<br>Other: MESH-Resistor 5<br>* Lung funtion testing with MasterScreen™ Body, CareFusion Germany GmbH, Mouthpiece with mesh-resistor (5hPa/L) to create laminar airflow<br>* Other names: Rudolph Flow Resistance Standards; HANS RUDOLPH, Inc.;Other: MESH-Resistor 10<br>* Lung funtion testing with MasterScreen™ Body, CareFusion Germany GmbH, Mouthpiece with mesh-resistor (10hPa/L) to create laminar airflow<br>* Other names: Rudolph Flow Resistance Standards; HANS RUDOLPH, inc;Other: Perforated Resistor 7<br>* Lung function testing with MasterScreen™ Body, CareFusion Germany GmbH, Mouthpiece with perforated resistor (inside diameter 7mm) to create a turbulent airflow<br>* Other names: 900MR405; Fisher&Paykel Healthcare;Other: Perforated Resistor 11<br>* Lung function testing with MasterScreen™ Body, CareFusion Germany GmbH, Mouthpiece with perforated resistor (inside diameter 11mm) to create a turbulent airflow<br>* Other names: 900MR406; Fisher&Paykel Healthcare;|
| Experimental: Patient 1<br>COPD patients, randomized lung function testing | Other: Baseline<br>* Lung function testing with MasterScreen™ Body, CareFusion Germany GmbH<br>Other: MESH-Resistor 5<br>* Lung funtion testing with MasterScreen™ Body, CareFusion Germany GmbH, Mouthpiece with mesh-resistor (5hPa/L) to create laminar airflow<br>* Other names: Rudolph Flow Resistance Standards; HANS RUDOLPH, Inc.;Other: MESH-Resistor 10<br>* Lung funtion testing with MasterScreen™ Body, CareFusion Germany GmbH, Mouthpiece with mesh-resistor (10hPa/L) to create laminar airflow<br>* Other names: Rudolph Flow Resistance Standards; HANS RUDOLPH, inc;|
| Experimental: Patient 2<br>COPD patients, randomized lung function testing | Other: Baseline<br>* Lung function testing with MasterScreen™ Body, CareFusion Germany GmbH<br>Other: Perforated Resistor 7<br>* Lung function testing with MasterScreen™ Body, CareFusion Germany GmbH, Mouthpiece with perforated resistor (inside diameter 7mm) to create a turbulent airflow<br>* Other names: 900MR405; Fisher&Paykel Healthcare;Other: Perforated Resistor 11<br>* Lung function testing with MasterScreen™ Body, CareFusion Germany GmbH, Mouthpiece with perforated resistor (inside diameter 11mm) to create a turbulent airflow<br>* Other names: 900MR406; Fisher&Paykel Healthcare;|
| Experimental: Patient 3<br>COPD patients, randomized lung function testing | Other: Baseline<br>* Lung function testing with MasterScreen™ Body, CareFusion Germany GmbH<br>Other: MESH-Resistor 5<br>* Lung funtion testing with MasterScreen™ Body, CareFusion Germany GmbH, Mouthpiece with mesh-resistor (5hPa/L) to create laminar airflow<br>* Other names: Rudolph Flow Resistance Standards; HANS RUDOLPH, Inc.;Other: Perforated Resistor 7<br>* Lung function testing with MasterScreen™ Body, CareFusion Germany GmbH, Mouthpiece with perforated resistor (inside diameter 7mm) to create a turbulent airflow<br>* Other names: 900MR405; Fisher&Paykel Healthcare;|
| Experimental: Patient 4<br>COPD patients, randomized lung function testing | Other: Baseline<br>* Lung function testing with MasterScreen™ Body, CareFusion Germany GmbH<br>Other: MESH-Resistor 5<br>* Lung funtion testing with MasterScreen™ Body, CareFusion Germany GmbH, Mouthpiece with mesh-resistor (5hPa/L) to create laminar airflow<br>* Other names: Rudolph Flow Resistance Standards; HANS RUDOLPH, Inc.;Other: Perforated Resistor 11<br>* Lung function testing with MasterScreen™ Body, CareFusion Germany GmbH, Mouthpiece with perforated resistor (inside diameter 11mm) to create a turbulent airflow<br>* Other names: 900MR406; Fisher&Paykel Healthcare;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung function parameter FEV1 | 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 | unit: L, measured with der MasterScreen™ Body, CareFusion | up to 1 hour | 
| RV%TLC | unit: %, measured with der MasterScreen™ Body, CareFusion | up to 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pursed-lips Breathing, Resistor