The Effect of Volitional Pursed-lips Breathing

NCT04663698 | Completed

• 1 other identifier: PLB2019
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

COPD

Keywords

Pursed-lips Breathing; Resistor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• PEF - expiratory Peak Flow

  up to 1 hour

• RV%TLC

  up to 1 hour

Study Arms (5)

Healthy

EXPERIMENTAL

Lung-healthy subjects, randomized lung function testing

Other: Baseline; Other: MESH-Resistor 5; Other: MESH-Resistor 10; Other: Perforated Resistor 7; Other: Perforated Resistor 11

Patient 1

EXPERIMENTAL

COPD patients, randomized lung function testing

Other: Baseline; Other: MESH-Resistor 5; Other: MESH-Resistor 10

Patient 2

EXPERIMENTAL

COPD patients, randomized lung function testing

Other: Baseline; Other: Perforated Resistor 7; Other: Perforated Resistor 11

Patient 3

EXPERIMENTAL

COPD patients, randomized lung function testing

Other: Baseline; Other: MESH-Resistor 5; Other: Perforated Resistor 7

Patient 4

EXPERIMENTAL

COPD patients, randomized lung function testing

Other: Baseline; Other: MESH-Resistor 5; Other: Perforated Resistor 11

Interventions

Baseline OTHER

Lung function testing with MasterScreen™ Body, CareFusion Germany GmbH

Healthy; Patient 1; Patient 2; Patient 3; Patient 4

MESH-Resistor 5 OTHER

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

Also known as: Rudolph Flow Resistance Standards; HANS RUDOLPH, Inc.

Healthy; Patient 1; Patient 3; Patient 4

MESH-Resistor 10 OTHER

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

Also known as: Rudolph Flow Resistance Standards; HANS RUDOLPH, inc

Healthy; Patient 1

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

Also known as: 900MR405; Fisher&Paykel Healthcare

Healthy; Patient 2; Patient 3

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

Also known as: 900MR406; Fisher&Paykel Healthcare

Healthy; Patient 2; Patient 4

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients:
• COPD (GOLD I- IV)
• Stable respiratory situation that allows routine lung funtion
• capable of communication
• Healthy:
• Lung Healthy
• capable of communication

You may not qualify if:

• 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

Sponsors & Collaborators

• Karl Josef Franke, PD DR med: lead

Study Sites (1)

Märkische Kliniken GmbH, Klinikum Lüdenscheid

Lüdenscheid, North Rhine-Westphalia, 58515, Germany

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

BaseLine dental cement

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Director

Study Record Dates

• First Submitted: October 22, 2020
• First Posted: December 11, 2020
• Study Start: September 11, 2019
• Primary Completion: January 8, 2021
• Study Completion: March 30, 2021
• Last Updated: September 14, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)