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Completed

NCT Number: NCT04663698

The Effect of Volitional Pursed-lips Breathing

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

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Key information

Conditions

COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Märkische Kliniken GmbH, Klinikum Lüdenscheid

Lüdenscheid, North Rhine-Westphalia, 58515, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Baseline

Other

Lung function testing with MasterScreen™ Body, CareFusion Germany GmbH

MESH-Resistor 5

Other

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

Other names: Rudolph Flow Resistance Standards; HANS RUDOLPH, Inc.

MESH-Resistor 10

Other

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

Other names: Rudolph Flow Resistance Standards; HANS RUDOLPH, inc

Perforated Resistor 7

Other

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

Other names: 900MR405; Fisher&Paykel Healthcare

Perforated Resistor 11

Other

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

Other names: 900MR406; Fisher&Paykel Healthcare

Primary outcomes

  1. 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

Secondary outcomes

  1. PEF - expiratory Peak Flow

    Time frame: up to 1 hour

    unit: L, measured with der MasterScreen™ Body, CareFusion

  2. RV%TLC

    Time frame: up to 1 hour

    unit: %, measured with der MasterScreen™ Body, CareFusion

Sponsors and collaborators

Lead sponsor

Karl Josef Franke, PD DR med

Industry

Registry information

Official study title

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

Acronym: PLB

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Dec 11, 2020
Registry last updated
Sep 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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