Journal of Physiotherapy 61 (2015) 93
Journal of
PHYSIOTHERAPY journal homepage: www.elsevier.com/locate/jphys
Appraisal
Trial Protocol
Efficacy of the addition of positive airway pressure to conventional chest physiotherapy in resolution of pleural effusion after drainage: protocol for a randomised controlled trial Elinaldo da Conceic¸a˜o dos Santos a,b, Adriana Claudia Lunardi a,c a
Master’s and Doctoral Programs in Physical Therapy, Universidade Cidade de Sa˜o Paulo; b Department of Biological and Health Sciences, Universidade Federal do Amapa´; c Department of Physical Therapy of School of Medicine, University of Sa˜o Paulo, Sa˜o Paulo, Brazil
Abstract Introduction: Chest drainage for pleural effusion can cause pain and changes in respiratory function. It can also increase the risk of pulmonary complications and impair functional ability, which may increase length of hospital stay and the associated costs. For these reasons, surgical and clinical strategies have been adopted to reduce the duration of chest drainage. Objectives: To evaluate the efficacy of the addition of intermittent positive airway pressure applied by the Muller reanimator via a rubber facial mask versus conventional physiotherapy on the duration of chest drainage (primary objective), and its effect on the recovery of respiratory function, length of hospital stay and incidence of pulmonary complications (secondary objectives). Design: Randomised, controlled trial. Participants and setting: Inpatients with pleural effusion, aged over 18 years, who have had chest drainage in situ for < 24 hours will be recruited from two university hospitals. Patients will be excluded if they have any contraindication for the use of non-invasive positive airway pressure. Intervention and control groups: After initial assessments of lung function, 156 patients will be randomised into a positive airway pressure group (positive airway pressure at 15 cmH2O plus conventional chest physiotherapy), a conventional chest physiotherapy group (conventional chest physiotherapy plus non-therapeutic positive airway pressure at 4 cmH2O) or a control group (non-therapeutic positive airway pressure at 4 cmH2O). All groups will receive treatment three times per day for 7 consecutive days. Measurements: A blinded assessor will conduct all assessments. Peripheral oxygenation and chest drainage output will be measured over 7 consecutive days. Lung function will be re-assessed on Day 4 and Day 8. The criteria for removal of the chest drain will be a transudate output 200 ml over 24 hours and full lung expansion
on chest radiography, as assessed by a blinded physician. Duration of chest drainage, length of hospital stay, and any pulmonary complications diagnosed during hospitalisation will be recorded. Analysis: Intention to treat using: survival analysis for duration of chest drainage, and length of hospital stay; analysis of variance for chest-tube output, lung function and peripheral oxygen saturation; and chi-square tests for comparing the incidence of pulmonary complications between groups. Discussion: Conventional chest physiotherapy and intermittent positive airway pressure breathing are widely indicated for people with pleural effusion and chest drains; however, no studies have evaluated the real benefit of this type of treatment. Our hypothesis is that optimised lung expansion achieved through the application of intermittent positive airway pressure will accelerate the reabsorption of pleural effusion, decrease the duration of chest drainage and respiratory system impairment, reduce the length of hospital stay, and reduce the incidence of pulmonary complications.
Trial registration: ClinicalTrials.gov. Registration number: NCT02246946. Was this trial prospectively registered: Yes, date: 16 September 2014. Funded by: Conselho Nacional de Desenvolvimento Cientı´fico e Tecnolo´gico-CNPq. Funder approval number: 442709/2014-5. Anticipated completion: September 2016. Correspondence: Dr Adriana Claudia Lunardi, Master’s and Doctoral Programs in Physical Therapy, Universidade Cidade de Sa˜o Paulo, Sa˜o Paulo, Brazil. Email: [email protected] Full protocol: Available on the eAddenda at doi:10.1016/j.jphys. 2014.11.016
http://dx.doi.org/10.1016/j.jphys.2014.11.016 1836-9553/ß 2014 Australian Physiotherapy Association. Published by Elsevier B.V. All rights reserved.
Journal of
PHYSIOTHERAPY journal homepage: www.elsevier.com/locate/jphys
Appraisal
Trial Protocol
Efficacy of the addition of positive airway pressure to conventional chest physiotherapy in resolution of pleural effusion after drainage: protocol for a randomised controlled trial Elinaldo da Conceic¸a˜o dos Santos a,b, Adriana Claudia Lunardi a,c a
Master’s and Doctoral Programs in Physical Therapy, Universidade Cidade de Sa˜o Paulo; b Department of Biological and Health Sciences, Universidade Federal do Amapa´; c Department of Physical Therapy of School of Medicine, University of Sa˜o Paulo, Sa˜o Paulo, Brazil
Abstract Introduction: Chest drainage for pleural effusion can cause pain and changes in respiratory function. It can also increase the risk of pulmonary complications and impair functional ability, which may increase length of hospital stay and the associated costs. For these reasons, surgical and clinical strategies have been adopted to reduce the duration of chest drainage. Objectives: To evaluate the efficacy of the addition of intermittent positive airway pressure applied by the Muller reanimator via a rubber facial mask versus conventional physiotherapy on the duration of chest drainage (primary objective), and its effect on the recovery of respiratory function, length of hospital stay and incidence of pulmonary complications (secondary objectives). Design: Randomised, controlled trial. Participants and setting: Inpatients with pleural effusion, aged over 18 years, who have had chest drainage in situ for < 24 hours will be recruited from two university hospitals. Patients will be excluded if they have any contraindication for the use of non-invasive positive airway pressure. Intervention and control groups: After initial assessments of lung function, 156 patients will be randomised into a positive airway pressure group (positive airway pressure at 15 cmH2O plus conventional chest physiotherapy), a conventional chest physiotherapy group (conventional chest physiotherapy plus non-therapeutic positive airway pressure at 4 cmH2O) or a control group (non-therapeutic positive airway pressure at 4 cmH2O). All groups will receive treatment three times per day for 7 consecutive days. Measurements: A blinded assessor will conduct all assessments. Peripheral oxygenation and chest drainage output will be measured over 7 consecutive days. Lung function will be re-assessed on Day 4 and Day 8. The criteria for removal of the chest drain will be a transudate output 200 ml over 24 hours and full lung expansion
on chest radiography, as assessed by a blinded physician. Duration of chest drainage, length of hospital stay, and any pulmonary complications diagnosed during hospitalisation will be recorded. Analysis: Intention to treat using: survival analysis for duration of chest drainage, and length of hospital stay; analysis of variance for chest-tube output, lung function and peripheral oxygen saturation; and chi-square tests for comparing the incidence of pulmonary complications between groups. Discussion: Conventional chest physiotherapy and intermittent positive airway pressure breathing are widely indicated for people with pleural effusion and chest drains; however, no studies have evaluated the real benefit of this type of treatment. Our hypothesis is that optimised lung expansion achieved through the application of intermittent positive airway pressure will accelerate the reabsorption of pleural effusion, decrease the duration of chest drainage and respiratory system impairment, reduce the length of hospital stay, and reduce the incidence of pulmonary complications.
Trial registration: ClinicalTrials.gov. Registration number: NCT02246946. Was this trial prospectively registered: Yes, date: 16 September 2014. Funded by: Conselho Nacional de Desenvolvimento Cientı´fico e Tecnolo´gico-CNPq. Funder approval number: 442709/2014-5. Anticipated completion: September 2016. Correspondence: Dr Adriana Claudia Lunardi, Master’s and Doctoral Programs in Physical Therapy, Universidade Cidade de Sa˜o Paulo, Sa˜o Paulo, Brazil. Email: [email protected] Full protocol: Available on the eAddenda at doi:10.1016/j.jphys. 2014.11.016
http://dx.doi.org/10.1016/j.jphys.2014.11.016 1836-9553/ß 2014 Australian Physiotherapy Association. Published by Elsevier B.V. All rights reserved.
