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Respiratory Therapy in COPD Exacerbations (TRESEPOCAS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Esther Marco Navarro, Parc de Salut Mar
ClinicalTrials.gov Identifier:
NCT02125747
First received: April 23, 2014
Last updated: January 11, 2017
Last verified: April 2015
  Purpose
The purpose of this study is to determine effectiveness, feasibility and safety/tolerance of Respiratory Therapy in hospitalized patients with acute exacerbations of chronic obstructive pulmonary disease.

Condition Intervention
Obstructive Chronic Bronchitis With Acute Exacerbation
Other: No Respiratory Therapy
Other: Respiratory Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Effectiveness of Respiratory Therapy in Acute Exacerbations of Chronic Obstructive Pulmonary Disease

Further study details as provided by Parc de Salut Mar:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 35
Study Start Date: December 2011
Study Completion Date: November 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Hospitalized patients with acute exacerbation of COPD.

Inclusion Criteria:

  • age over 18 years,
  • hospitalized patients and
  • acute exacerbation of COPD.

Exclusion Criteria:

  • Previous history of any chronic respiratory disease and
  • not to have performed any kind of general or respiratory training in the previous 3 months.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02125747

Locations
Spain
Departments of Respiratory Medicine and Rehabilitation. Parc de Salut Mar, Hospital del Mar
Barcelona, Spain, 08003
Sponsors and Collaborators
Parc de Salut Mar
Investigators
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
  More Information

Publications:

Responsible Party: Esther Marco Navarro, PhD, Parc de Salut Mar
ClinicalTrials.gov Identifier: NCT02125747     History of Changes
Other Study ID Numbers: PSM/RHB/CR/05
Study First Received: April 23, 2014
Last Updated: January 11, 2017

Keywords provided by Parc de Salut Mar:
Respiratory muscle training; high-intensity training

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

ClinicalTrials.gov processed this record on March 24, 2017