Respiratory Therapy in COPD Exacerbations

Obstructive Chronic Bronchitis With Acute Exacerbation Clinical Trial

— TRESEPOCAS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02125747
• Other study ID #: PSM/RHB/CR/05
• Status: Completed
• Phase: N/A
• First received: April 23, 2014
• Last updated: January 11, 2017
• Start date: December 2011
• Est. completion date: November 2012

Study information

• Verified date: April 2015
• Source: Parc de Salut Mar
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: November 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bronchitis
• Bronchitis, Chronic
• Obstructive Chronic Bronchitis With Acute Exacerbation

Intervention

Other:
• No Respiratory Therapy
Patients received conventional treatment.
• 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.

Locations

Country	Name	City	State
Spain	Departments of Respiratory Medicine and Rehabilitation. Parc de Salut Mar, Hospital del Mar	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Parc de Salut Mar

Country where clinical trial is conducted

Spain, 

References & Publications (19)

Elkins MR, Jones A, van der Schans C. Positive expiratory pressure physiotherapy for airway clearance in people with cystic fibrosis. Cochrane Database Syst Rev. 2006 Apr 19;(2):CD003147. Review. Update in: Cochrane Database Syst Rev. 2015;6:CD003147. — View Citation

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. — View Citation

Gulsvik A. The global burden and impact of chronic obstructive pulmonary disease worldwide. Monaldi Arch Chest Dis. 2001 Jun;56(3):261-4. Review. — View Citation

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. Review. — View Citation

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. Review. Erratum in: COPD. 2011 Dec;8(6):468. Vissers, Dick [corrected to Vissers, Dirk]. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Newton DA, Stephenson A. Effect of physiotherapy on pulmonary function. A laboratory study. Lancet. 1978 Jul 29;2(8083):228-9. — View Citation

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. — View Citation

Opdekamp C, Sergysels R. [Respiratory physiotherapy in lung diseases]. Rev Med Brux. 2003 Sep;24(4):A231-5. Review. French. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

van der Schans CP. Conventional chest physical therapy for obstructive lung disease. Respir Care. 2007 Sep;52(9):1198-206; discussion 1206-9. Review. — View Citation

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. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Measure of safety and tolerability	Presence of complications and patients' satisfaction	Participants will be followed for the duration of hospital stay, an expected average of 10 days	Yes
Secondary	Adverse events as a measure of safety and tolerability	Monitoring of health status and possible complications one year after discharge	One year after hospital discharge	Yes