The Effect of Volitional Pursed-lips Breathing (PLB)

Institut für Pneumologie Hagen Ambrock

Status: Completed

Conditions: COPD

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT04663698

PLB2019

Details and patient eligibility

About

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

Full 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.

Enrollment: 110 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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110 participants in 5 patient groups

Healthy

Experimental group

Description:

Lung-healthy subjects, randomized lung function testing

Treatment:

Other: Baseline

Other: Perforated Resistor 7

Other: MESH-Resistor 5

Other: Perforated Resistor 11

Other: MESH-Resistor 10

Patient 1

Experimental group

Description:

COPD patients, randomized lung function testing

Treatment:

Other: Baseline

Other: MESH-Resistor 5

Other: MESH-Resistor 10

Patient 2

Experimental group

Description:

COPD patients, randomized lung function testing

Treatment:

Other: Baseline

Other: Perforated Resistor 7

Other: Perforated Resistor 11

Patient 3

Experimental group

Description:

COPD patients, randomized lung function testing

Treatment:

Other: Baseline

Other: Perforated Resistor 7

Other: MESH-Resistor 5

Patient 4

Experimental group

Description:

COPD patients, randomized lung function testing

Treatment:

Other: Baseline

Other: MESH-Resistor 5

Other: Perforated Resistor 11