A Comparison Study of Two Respiratory Physical Therapy Methods and Standard Medical Treatment for Treating COPD Patients During Acute Exacerbation

NCT ID: NCT02140892

Last Updated: 2014-05-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2015-12-31

Brief Summary

One of the main goals of the respiratory physical therapy is to help people who are suffering from accumulating of secretions in their airways and lungs.

Chronic Obstructive Pulmonary Disease (COPD) patients are often hospitalized with an Acute Exacerbation of their medical condition.

Those patients usually get only the standard medical care during the acute phase and don't get respiratory physical therapy treatment.

The study's main aim is to investigate if respiratory physical therapy treatment in addition to standard medical care during the acute phase, can improve the respiratory and medical condition and reduce hospitalization stay.

In order to do so we will compare three groups of COPD patients during acute exacerbation; two groups will get one out of two respiratory physical therapy techniques; manually or Intrapulmonary Percussive Ventilator (IPV) in addition to standard medical care and the third group will get standard medical care alone.

Conditions

Chronic Obstructive Pulmonary Disease; Chronic Bronchitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

respiratory physical therapy manual technique

respiratory physical therapy manual technique- Autogenic Drainage

Group Type: EXPERIMENTAL

respiratory physical therapy manual technique- Autogenic Drainage

Intervention Type: PROCEDURE

respiratory physical therapy technique- IPV

respiratory physical therapy technique- Intrapulmonary Percussive Ventilation

Group Type: EXPERIMENTAL

respiratory physical therapy technique- IPV

Intervention Type: DEVICE

standart medical care

standard medical care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

respiratory physical therapy manual technique- Autogenic Drainage

Intervention Type: PROCEDURE

respiratory physical therapy technique- IPV

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• clinical diagnosis of Acute Exacerbation of COPD or Acute Exacerbation of Chronic Bronchitis
• Respiratory Rate>25
• PaCO2> 45 mmHg
• 7.35 < PH < 7.38

Exclusion Criteria

• intubation
• apnea
• glasgow coma scale < 8
• pneumothorax
• FEV1 < 50% predicted
• Ischemic Hearth Disease

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sheba Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Yaakov (kobi) Dagan, Msc.

Role: CONTACT

kobi.dagan@sheba.health.gov.il

0523694979

Other Identifiers

SHEBA-13-0697-YO-CTIL

Identifier Type: -

Identifier Source: org_study_id