An interventional study of No Respiratory Therapy and Respiratory Therapy in Obstructive Chronic Bronchitis With Acute Exacerbation, sponsored by Parc de Salut Mar. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-01-12.
Sponsored by Parc de Salut Mar · Not applicable, Interventional, and Treatment
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.
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.
Parc de Salut Mar is the lead sponsor of 182 studies on the registry; 27 are open to participants now.
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Hospitalized patients with acute exacerbation of COPD.
Inclusion Criteria:
Exclusion Criteria:
Patients with acute exacerbation of chronic obstructive pulmonary disease. Patients received conventional treatment.
Other: No Respiratory Therapy
Patients with acute exacerbation of chronic obstructive pulmonary disease. Patients received conventional treatment and Respiratory Therapy
Other: Respiratory Therapy
Patients received conventional treatment.
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
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.
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 10 days
Measure of safety and tolerability
Presence of complications and patients' satisfaction
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 10 days
Adverse events as a measure of safety and tolerability
Monitoring of health status and possible complications one year after discharge
Time frame: One year after hospital discharge
The record gives a start of Dec 2011, a primary completion of May 2012 and a completion of Nov 2012. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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