The Effect of Volitional Pursed-lips Breathing

Not Applicable

Completed

• Conditions: COPD
• Interventions: Other: Baseline; Other: MESH-Resistor 5; Other: MESH-Resistor 10; Other: Perforated Resistor 7; Other: Perforated Resistor 11

• Registration Number: NCT04663698
• Lead Sponsor: Karl Josef Franke, PD DR med

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.

Study Timeline

• Study Start: 2019-09-11
• Study First Submitted: 2020-10-22
• Study First Submitted QC: 2020-12-10
• Study First Posted: 2020-12-11
• Primary Completion: 2021-01-08
• Study Completion: 2021-03-30
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-13
• Last Update Posted: 2021-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Healthy	MESH-Resistor 10	Lung-healthy subjects, randomized lung function testing
Patient 1	Baseline	COPD patients, randomized lung function testing
Patient 1	MESH-Resistor 5	COPD patients, randomized lung function testing
Patient 3	MESH-Resistor 5	COPD patients, randomized lung function testing
Patient 4	Baseline	COPD patients, randomized lung function testing
Healthy	Perforated Resistor 7	Lung-healthy subjects, randomized lung function testing
Patient 3	Perforated Resistor 7	COPD patients, randomized lung function testing
Healthy	Perforated Resistor 11	Lung-healthy subjects, randomized lung function testing
Patient 3	Baseline	COPD patients, randomized lung function testing
Patient 4	MESH-Resistor 5	COPD patients, randomized lung function testing
Healthy	Baseline	Lung-healthy subjects, randomized lung function testing
Patient 1	MESH-Resistor 10	COPD patients, randomized lung function testing
Patient 2	Perforated Resistor 7	COPD patients, randomized lung function testing
Patient 4	Perforated Resistor 11	COPD patients, randomized lung function testing
Healthy	MESH-Resistor 5	Lung-healthy subjects, randomized lung function testing
Patient 2	Baseline	COPD patients, randomized lung function testing
Patient 2	Perforated Resistor 11	COPD patients, randomized lung function testing

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Märkische Kliniken GmbH, Klinikum Lüdenscheid; 🇩🇪 Lüdenscheid, NRW, Germany