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

Intervention / Treatment

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

  • Germany
    • 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
Other: Baseline
Lung function testing with MasterScreen™ Body, CareFusion Germany GmbH
Other: MESH-Resistor 5
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.
Other: MESH-Resistor 10
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
Other: Perforated Resistor 7
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
Other: Perforated Resistor 11
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
EXPERIMENTAL: Patient 1
COPD patients, randomized lung function testing
Other: Baseline
Lung function testing with MasterScreen™ Body, CareFusion Germany GmbH
Other: MESH-Resistor 5
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.
Other: MESH-Resistor 10
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
EXPERIMENTAL: Patient 2
COPD patients, randomized lung function testing
Other: Baseline
Lung function testing with MasterScreen™ Body, CareFusion Germany GmbH
Other: Perforated Resistor 7
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
Other: Perforated Resistor 11
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
EXPERIMENTAL: Patient 3
COPD patients, randomized lung function testing
Other: Baseline
Lung function testing with MasterScreen™ Body, CareFusion Germany GmbH
Other: MESH-Resistor 5
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.
Other: Perforated Resistor 7
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
EXPERIMENTAL: Patient 4
COPD patients, randomized lung function testing
Other: Baseline
Lung function testing with MasterScreen™ Body, CareFusion Germany GmbH
Other: MESH-Resistor 5
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.
Other: Perforated Resistor 11
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

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

Karl Josef Franke, PD DR med

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.

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