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Completed

NCT Number: NCT02125747

Respiratory Therapy in COPD Exacerbations

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Departments of Respiratory Medicine and Rehabilitation. Parc de Salut Mar, Hospital del Mar

Barcelona, 08003, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No Respiratory Therapy

Other

Patients received conventional treatment.

Respiratory therapy

Other

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.

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Parc de Salut Mar

Other

Registry information

Official study title

Effectiveness of Respiratory Therapy in Acute Exacerbations of Chronic Obstructive Pulmonary Disease

Acronym: TRESEPOCAS

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Apr 29, 2014
Registry last updated
Jan 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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