TRESEPOCAS: Respiratory Therapy in COPD Exacerbations
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: 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.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
Eligibility Criteria
Criteria
Hospitalized patients with acute exacerbation of COPD.
Inclusion Criteria:
-
age over 18 years,
-
hospitalized patients and
-
acute exacerbation of COPD.
Exclusion Criteria:
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Previous history of any chronic respiratory disease and
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not to have performed any kind of general or respiratory training in the previous 3 months.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
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- Garrod R, Lasserson T. Role of physiotherapy in the management of chronic lung diseases: an overview of systematic reviews. Respir Med. 2007 Dec;101(12):2429-36. Epub 2007 Sep 17.
- Gulsvik A. The global burden and impact of chronic obstructive pulmonary disease worldwide. Monaldi Arch Chest Dis. 2001 Jun;56(3):261-4. Review.
- Hill K, Patman S, Brooks D. Effect of airway clearance techniques in patients experiencing an acute exacerbation of chronic obstructive pulmonary disease: a systematic review. Chron Respir Dis. 2010;7(1):9-17. doi: 10.1177/1479972309348659. Epub 2009 Oct 9. Review.
- Ides K, Vissers D, De Backer L, Leemans G, De Backer W. Airway clearance in COPD: need for a breath of fresh air? A systematic review. COPD. 2011 Jun;8(3):196-205. doi: 10.3109/15412555.2011.560582. Epub 2011 Apr 22. Review. Erratum in: COPD. 2011 Dec;8(6):468. Vissers, Dick [corrected to Vissers, Dirk].
- Jones AP, Rowe BH. Bronchopulmonary hygiene physical therapy for chronic obstructive pulmonary disease and bronchiectasis. Cochrane Database Syst Rev. 2000;(2):CD000045. Review. Update in: Cochrane Database Syst Rev. 2011;(7):CD000045.
- Lange P, Nyboe J, Appleyard M, Jensen G, Schnohr P. Relation of ventilatory impairment and of chronic mucus hypersecretion to mortality from obstructive lung disease and from all causes. Thorax. 1990 Aug;45(8):579-85.
- Miravitlles M, Ferrer M, Pont A, Zalacain R, Alvarez-Sala JL, Masa F, Verea H, Murio C, Ros F, Vidal R; IMPAC Study Group. Effect of exacerbations on quality of life in patients with chronic obstructive pulmonary disease: a 2 year follow up study. Thorax. 2004 May;59(5):387-95.
- Mohsenifar Z, Rosenberg N, Goldberg HS, Koerner SK. Mechanical vibration and conventional chest physiotherapy in outpatients with stable chronic obstructive lung disease. Chest. 1985 Apr;87(4):483-5.
- Newton DA, Stephenson A. Effect of physiotherapy on pulmonary function. A laboratory study. Lancet. 1978 Jul 29;2(8083):228-9.
- Olséni L, Midgren B, Hörnblad Y, Wollmer P. Chest physiotherapy in chronic obstructive pulmonary disease: forced expiratory technique combined with either postural drainage or positive expiratory pressure breathing. Respir Med. 1994 Jul;88(6):435-40.
- Opdekamp C, Sergysels R. [Respiratory physiotherapy in lung diseases]. Rev Med Brux. 2003 Sep;24(4):A231-5. Review. French.
- Osadnik CR, McDonald CF, Jones AP, Holland AE. Airway clearance techniques for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2012 Mar 14;(3):CD008328. doi: 10.1002/14651858.CD008328.pub2. Review.
- Puhan MA, Scharplatz M, Troosters T, Steurer J. Respiratory rehabilitation after acute exacerbation of COPD may reduce risk for readmission and mortality -- a systematic review. Respir Res. 2005 Jun 8;6:54. Review.
- Sivasothy P, Brown L, Smith IE, Shneerson JM. Effect of manually assisted cough and mechanical insufflation on cough flow of normal subjects, patients with chronic obstructive pulmonary disease (COPD), and patients with respiratory muscle weakness. Thorax. 2001 Jun;56(6):438-44.
- Standards for the diagnosis and care of patients with chronic obstructive pulmonary disease. American Thoracic Society. Am J Respir Crit Care Med. 1995 Nov;152(5 Pt 2):S77-121. Review.
- Tang CY, Taylor NF, Blackstock FC. Chest physiotherapy for patients admitted to hospital with an acute exacerbation of chronic obstructive pulmonary disease (COPD): a systematic review. Physiotherapy. 2010 Mar;96(1):1-13. doi: 10.1016/j.physio.2009.06.008. Epub 2009 Sep 22. Review.
- van der Schans CP. Conventional chest physical therapy for obstructive lung disease. Respir Care. 2007 Sep;52(9):1198-206; discussion 1206-9. Review.
- Wolkove N, Kamel H, Rotaple M, Baltzan MA Jr. Use of a mucus clearance device enhances the bronchodilator response in patients with stable COPD. Chest. 2002 Mar;121(3):702-7.
- PSM/RHB/CR/05