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

Chronic Obstructive Pulmonary Disease Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02140892
• Other study ID #: SHEBA-13-0697-YO-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: May 14, 2014
• Last updated: May 15, 2014
• Start date: July 2014
• Est. completion date: December 2015

Study information

• Verified date: May 2014
• Source: Sheba Medical Center
• Contact: Yaakov (kobi) Dagan, Msc.
• Phone: 0523694979
• Email: kobi.dagan[@]sheba.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 75
• Est. completion date: December 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bronchitis
• Bronchitis, Chronic
• Chronic Bronchitis
• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Procedure:
• respiratory physical therapy manual technique- Autogenic Drainage

Device:
• respiratory physical therapy technique- IPV

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	length of stay in the hospital		up to three months	No