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The Effect of Volitional Pursed-lips Breathing

NCT ID: NCT04663698

Last Updated: 2021-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-11

Study Completion Date

2021-03-30

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

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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.

Conditions

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COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Healthy

Lung-healthy subjects, randomized lung function testing

Group Type EXPERIMENTAL

Baseline

Intervention Type OTHER

Lung function testing with MasterScreen™ Body, CareFusion Germany GmbH

MESH-Resistor 5

Intervention Type OTHER

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

MESH-Resistor 10

Intervention Type OTHER

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

Perforated Resistor 7

Intervention Type OTHER

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

Perforated Resistor 11

Intervention Type OTHER

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

Patient 1

COPD patients, randomized lung function testing

Group Type EXPERIMENTAL

Baseline

Intervention Type OTHER

Lung function testing with MasterScreen™ Body, CareFusion Germany GmbH

MESH-Resistor 5

Intervention Type OTHER

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

MESH-Resistor 10

Intervention Type OTHER

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

Patient 2

COPD patients, randomized lung function testing

Group Type EXPERIMENTAL

Baseline

Intervention Type OTHER

Lung function testing with MasterScreen™ Body, CareFusion Germany GmbH

Perforated Resistor 7

Intervention Type OTHER

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

Perforated Resistor 11

Intervention Type OTHER

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

Patient 3

COPD patients, randomized lung function testing

Group Type EXPERIMENTAL

Baseline

Intervention Type OTHER

Lung function testing with MasterScreen™ Body, CareFusion Germany GmbH

MESH-Resistor 5

Intervention Type OTHER

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

Perforated Resistor 7

Intervention Type OTHER

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

Patient 4

COPD patients, randomized lung function testing

Group Type EXPERIMENTAL

Baseline

Intervention Type OTHER

Lung function testing with MasterScreen™ Body, CareFusion Germany GmbH

MESH-Resistor 5

Intervention Type OTHER

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

Perforated Resistor 11

Intervention Type OTHER

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

Interventions

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Baseline

Lung function testing with MasterScreen™ Body, CareFusion Germany GmbH

Intervention Type OTHER

MESH-Resistor 5

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

Intervention Type OTHER

MESH-Resistor 10

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

Intervention Type 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

Intervention Type 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

Intervention Type OTHER

Other Intervention Names

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Rudolph Flow Resistance Standards; HANS RUDOLPH, Inc. Rudolph Flow Resistance Standards; HANS RUDOLPH, inc 900MR405; Fisher&Paykel Healthcare 900MR406; Fisher&Paykel Healthcare

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Karl Josef Franke, PD DR med

INDUSTRY

Sponsor Role lead

Responsible Party

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Karl Josef Franke, PD DR med

Clinical Director

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Märkische Kliniken GmbH, Klinikum Lüdenscheid

Lüdenscheid, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

Other Identifiers

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PLB2019

Identifier Type: -

Identifier Source: org_study_id

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