Respiratory Therapy in COPD Exacerbations

NCT02125747 | Completed

• 1 other identifier: PSM/RHB/CR/05
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Chronic Bronchitis With Acute Exacerbation

Keywords

Respiratory muscle training; high-intensity training

Outcome Measures

Primary Outcomes (1)

• 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.

  Participants will be followed for the duration of hospital stay, an expected average of 10 days

Secondary Outcomes (2)

• Measure of safety and tolerability

  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

  One year after hospital discharge

Study Arms (2)

No Respiratory Therapy

OTHER

Patients with acute exacerbation of chronic obstructive pulmonary disease. Patients received conventional treatment.

Other: No Respiratory Therapy

Respiratory therapy

EXPERIMENTAL

Patients with acute exacerbation of chronic obstructive pulmonary disease. Patients received conventional treatment and Respiratory Therapy

Other: Respiratory Therapy

Interventions

No Respiratory Therapy OTHER

Patients received conventional treatment.

No Respiratory Therapy

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.

Respiratory therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Previous history of any chronic respiratory disease and
• not to have performed any kind of general or respiratory training in the previous 3 months.

Sponsors & Collaborators

• Parc de Salut Mar: lead

Study Sites (1)

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

Barcelona, Barcelona, 08003, Spain

Location

Related Publications (19)

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MeSH Terms

Interventions

Respiratory Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: April 23, 2014
• First Posted: April 29, 2014
• Study Start: December 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: November 1, 2012
• Last Updated: January 12, 2017

Record last verified: 2015-04

Locations

ES (1)