Respiratory Therapy in COPD Exacerbations (TRESEPOCAS)
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|ClinicalTrials.gov Identifier: NCT02125747|
Recruitment Status : Completed
First Posted : April 29, 2014
Last Update Posted : January 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Obstructive Chronic Bronchitis With Acute Exacerbation||Other: No Respiratory Therapy Other: Respiratory Therapy||Not Applicable|
Acute exacerbation of chronic obstructive pulmonary disease (AE-COPD) is defined as an event in the natural course of the disease characterized by a change in the patient's usual symptoms (dyspnea, cough and/or sputum) that may not be explained by the daily variations and requires a change in regular medication.
Because AE-COPD result in impairment of both pulmonary and respiratory muscle functions, as well as an increasing impact on costs, priority should be given to interventions to slow the progression of the disease, prevention of exacerbations and reduce the risk of comorbidity.
Chest physiotherapy is often used in hospitalized patients with AE-COPD with the aim of favoring the removal of secretions and thus to improve the ventilation perfusion (V/Q), and therefore the function lung. The limited scientific evidence has determined that their use is controversial and not routinely recommended in clinical practice guidelines. Current clinical guidelines in the treatment of COPD are unable to rule on the application of respiratory therapy during exacerbations, since there is little scientific evidence of its benefits in the short and long term.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Effectiveness of Respiratory Therapy in Acute Exacerbations of Chronic Obstructive Pulmonary Disease|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||November 2012|
No Respiratory Therapy
Patients with acute exacerbation of chronic obstructive pulmonary disease. Patients received conventional treatment.
Other: No Respiratory Therapy
Patients received conventional treatment.
Experimental: Respiratory therapy
Patients with acute exacerbation of chronic obstructive pulmonary disease. Patients received conventional treatment and Respiratory Therapy
Other: Respiratory Therapy
Respiratory Therapy consists of postural drainage, positive expiratory pressure (PEP) and vibropercussion (it is a postural drainage method, which uses chest clapping with a flexible wrist and cupped hands or a mechanical vibrator to loosen and mobilize retained secretions that can then be expectorated or drained). Postural drainage is an airways clearance technique in which patient's body is positioned so that the trachea is inclined downward and below the affected chest area.
The PEP consists of expiratory cycles through a system generating a positive pressure of 10-20 cc (cubic centimeter) water. Vibropercussion is applied by the use of a mechanical system following rib movement during expiration to enhance clearance of secretions.
Intervention group received 30-minute-sessions twice a day, 7 days per week, during hospitalization period.
- Respiratory muscle strength [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 10 days ]Respiratory muscle strength is assessed through maximal inspiratory pressures (MIP) and maximal expiratory pressures (MEP) using a pressure transducer connected to a digital register system. The MIP is measured at mouth during a maximum effort from residual volume against occluded airway. To determine the MEP, patients performed a maximum expiratory effort from total lung capacity in the face of the occluded airway.
- Measure of safety and tolerability [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 10 days ]Presence of complications and patients' satisfaction
- Adverse events as a measure of safety and tolerability [ Time Frame: One year after hospital discharge ]Monitoring of health status and possible complications one year after discharge
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): NCT02125747
|Departments of Respiratory Medicine and Rehabilitation. Parc de Salut Mar, Hospital del Mar|
|Barcelona, Spain, 08003|
|Study Director:||Mauricio Orozco-Levi, MD, PhD||Biomedical Research Network for Respiratory Diseases (CIBERES), ISCIII, Ministerio de Ciencia y Tecnología, Spain; Respiratory Department, Hospital del Mar, Spain; Respiratory Department, Centro de Investigaciones, Fundación Cardiovascular de Colombia|