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 Conceição dos Santos a,b, Adriana Claudia Lunardi a,c
a
Master’s and Doctoral Programs in Physical Therapy, Universidade Cidade de São Paulo; b Department of Biological and Health Sciences, Universidade Federal do Amapá;
c
Department of Physical Therapy of School of Medicine, University of São Paulo, São 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, con-
trolled 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. Measure-
ments: 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 Desenvolvi-
mento Cientı́fico e Tecnológico-CNPq. Funder approval number:
442709/2014-5. Anticipated completion: September 2016. Corre-
spondence: Dr Adriana Claudia Lunardi, Master’s and Doctoral Pro-
grams in Physical Therapy, Universidade Cidade de São Paulo, São
Paulo, Brazil. Email: adriana.lunardi@unicid.edu.br
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.