The Effect of Volitional Pursed-lips Breathing

COPD Clinical Trial

— PLB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04663698
• Other study ID #: PLB2019
• Status: Completed
• Phase: N/A
• Start date: September 11, 2019
• Est. completion date: March 30, 2021

Study information

• Verified date: September 2021
• Source: Institut für Pneumologie Hagen Ambrock eV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: March 30, 2021
• Est. primary completion date: January 8, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• COPD

Intervention

Other:
• Baseline
Lung function testing with MasterScreen™ Body, CareFusion Germany GmbH
• MESH-Resistor 5
Lung funtion testing with MasterScreen™ Body, CareFusion Germany GmbH, Mouthpiece with mesh-resistor (5hPa/L) to create laminar airflow
• MESH-Resistor 10
Lung funtion testing with MasterScreen™ Body, CareFusion Germany GmbH, Mouthpiece with mesh-resistor (10hPa/L) to create laminar airflow
• Perforated Resistor 7
Lung function testing with MasterScreen™ Body, CareFusion Germany GmbH, Mouthpiece with perforated resistor (inside diameter 7mm) to create a turbulent airflow
• Perforated Resistor 11
Lung function testing with MasterScreen™ Body, CareFusion Germany GmbH, Mouthpiece with perforated resistor (inside diameter 11mm) to create a turbulent airflow

Locations

Country	Name	City	State
Germany	Märkische Kliniken GmbH, Klinikum Lüdenscheid	Lüdenscheid	NRW

Sponsors (1)

Lead Sponsor	Collaborator
Karl Josef Franke, PD DR med

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	PEF - expiratory Peak Flow	unit: L, measured with der MasterScreen™ Body, CareFusion	up to 1 hour
Secondary	RV%TLC	unit: %, measured with der MasterScreen™ Body, CareFusion	up to 1 hour