The Effect of Volitional Pursed-lips Breathing

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04663698

Acronym

PLB

Enrollment

110

Registered

2020-12-11

Start date

2019-09-11

Completion date

2021-03-30

Last updated

2021-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD

Keywords

Pursed-lips Breathing, Resistor

Brief summary

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

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.

Interventions

OTHERBaseline

Lung function testing with MasterScreen™ Body, CareFusion Germany GmbH

OTHERMESH-Resistor 5

Lung funtion testing with MasterScreen™ Body, CareFusion Germany GmbH, Mouthpiece with mesh-resistor (5hPa/L) to create laminar airflow

OTHERMESH-Resistor 10

Lung funtion testing with MasterScreen™ Body, CareFusion Germany GmbH, Mouthpiece with mesh-resistor (10hPa/L) to create laminar airflow

OTHERPerforated Resistor 7

Lung function testing with MasterScreen™ Body, CareFusion Germany GmbH, Mouthpiece with perforated resistor (inside diameter 7mm) to create a turbulent airflow

OTHERPerforated Resistor 11

Lung function testing with MasterScreen™ Body, CareFusion Germany GmbH, Mouthpiece with perforated resistor (inside diameter 11mm) to create a turbulent airflow

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Lung function parameter FEV1	up to 1 hour	Measuring of lung function parameters with different resistors to simulate PLB unit: L, measured with der MasterScreen™ Body, CareFusion

Secondary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026