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

NCT ID: NCT01507844

Last Updated: 2012-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2011-06-30

Brief Summary

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.

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.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

ventilation

Group Type: SHAM_COMPARATOR

positive ventilation

Intervention Type: DEVICE

10 minutes of increased 4,7,12 positive pressure ventilation

Interventions

positive ventilation

10 minutes of increased 4,7,12 positive pressure ventilation

Intervention Type: DEVICE

Other Intervention Names

CPAP

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• active ischemic heart disease
• heart failure
• peripheral vascular disease

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assaf-Harofeh Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David stav, MD

Role: PRINCIPAL_INVESTIGATOR

Assaf-Harofeh Medical Center

Locations

Pulmonary Institute

Beer Yaakov, , Israel

Countries

Israel

Other Identifiers

12

Identifier Type: OTHER

Identifier Source: secondary_id

86/09

Identifier Type: -

Identifier Source: org_study_id