Respiratory Therapy in COPD Exacerbations

Not Applicable

Completed

• Conditions: Obstructive Chronic Bronchitis With Acute Exacerbation
• Interventions: Other: No Respiratory Therapy; Other: Respiratory Therapy

• Registration Number: NCT02125747
• Lead Sponsor: Parc de Salut Mar

Brief Summary

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.

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.

Study Timeline

• Study Start: 2011-12
• Primary Completion: 2012-05
• Study Completion: 2012-11
• Study First Submitted: 2014-04-23
• Study First Submitted QC: 2014-04-25
• Study First Posted: 2014-04-29
• Status Verified: 2015-04
• Last Update Submitted: 2017-01-11
• Last Update Posted: 2017-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No Respiratory Therapy	No Respiratory Therapy	Patients with acute exacerbation of chronic obstructive pulmonary disease. Patients received conventional treatment.
Respiratory therapy	Respiratory Therapy	Patients with acute exacerbation of chronic obstructive pulmonary disease. Patients received conventional treatment and Respiratory Therapy

Primary Outcome Measures

Name	Time	Method
Respiratory muscle strength	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

Name	Time	Method
Measure of safety and tolerability	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	One year after hospital discharge	Monitoring of health status and possible complications one year after discharge

Trial Locations

Locations (1)

Departments of Respiratory Medicine and Rehabilitation. Parc de Salut Mar, Hospital del Mar; 🇪🇸 Barcelona, Spain