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Clinical Trials/NCT04663698
NCT04663698
Completed
Not Applicable

Evaluation of PLB Physiology in COPD - Untersuchung Zur Physiologie Der Lippenbremse Bei COPD

Karl Josef Franke, PD DR med1 site in 1 country110 target enrollmentSeptember 11, 2019
ConditionsCOPD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COPD
Sponsor
Karl Josef Franke, PD DR med
Enrollment
110
Locations
1
Primary Endpoint
Lung function parameter FEV1
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 11, 2019
End Date
March 30, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Karl Josef Franke, PD DR med
Responsible Party
Sponsor Investigator
Principal Investigator

Karl Josef Franke, PD DR med

Clinical Director

Institut für Pneumologie Hagen Ambrock eV

Eligibility Criteria

Inclusion Criteria

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • RV%TLC(up to 1 hour)
  • PEF - expiratory Peak Flow(up to 1 hour)

Study Sites (1)

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