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Continuous Positive Airway Pressure Effect on Air Trapping in Chronic Obstructive Pulmonary Disease Patients (CPAP)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01507844
First Posted: January 11, 2012
Last Update Posted: January 11, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Assaf-Harofeh Medical Center
  Purpose
Chronic obstructive pulmonary disease is a disease characterized by small airways inflammation and obstruction. The small airways disease produces hyperinflation (air trapping), which increases with exercise. Continuous positive airways pressure may reduce small airways obstruction and therefore air trapping. Pulmonary function tests including lung volumes at rest and and after exercise will be measured. In addition, exercise endurance time before treatment and after treatment will be measured.

Condition Intervention
Chronic Obstructive Pulmonary Disease Device: positive ventilation

Study Type: Interventional
Study Design: Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Continuous Positive Airway Pressure Effect on Air Trapping, Endurance Time in Chronic Obstructive Pulmonary Disease Patients

Resource links provided by NLM:


Further study details as provided by Assaf-Harofeh Medical Center:

Primary Outcome Measures:
  • improved small airways obstruction [ Time Frame: 2-3 hrs ]
    Following CPAP ventilation measurement be repeated for 3 hrs


Secondary Outcome Measures:
  • improved respiratory symptoms [ Time Frame: 2-3 hrs ]
    CAT score


Enrollment: 24
Study Start Date: November 2009
Study Completion Date: June 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: ventilation Device: positive ventilation
10 minutes of increased 4,7,12 positive pressure ventilation
Other Name: CPAP

Detailed Description:
Continuous positive airways pressure which prevent small air ways collapse and may also clear secretions. At first stage the optimal pressure for reducing air trapping will be determined. In addition, all patients will undergo a maximal exercise test. A baseline complete pulmonary function test is performed followed by continuous positive air way pressure at the pre-determined pressure. This will be followed by exercise at 60% of maximal obtained previously.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • chronic obstructive lung disease stage 2-3 GOLD
  • FRC > 120%

Exclusion Criteria:

  • active ischemic heart disease
  • heart failure
  • peripheral vascular disease
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01507844


Locations
Israel
Pulmonary Institute
Beer Yaakov, Israel, 70300
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Investigators
Principal Investigator: David stav, MD Assaf-Harofeh Medical Center
  More Information

Responsible Party: Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT01507844     History of Changes
Other Study ID Numbers: 86/09
12 ( Other Identifier: Israel lung Association )
First Submitted: November 2, 2009
First Posted: January 11, 2012
Last Update Posted: January 11, 2012
Last Verified: November 2011

Keywords provided by Assaf-Harofeh Medical Center:
COPD
CPAP
Sham
FEV1
IC
RV/TLC

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases