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Trial registered on ANZCTR


Registration number
ACTRN12608000420347
Ethics application status
Approved
Date submitted
24/07/2008
Date registered
25/08/2008
Date last updated
25/08/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Mechanical Ventilator as a physical therapy device to improve airway clearance in critical care patients.
Scientific title
Mechanical ventilator hyperinflation improves sputum production and respiratory mechanics in hypersecretive critical care patients.
Secondary ID [1] 687 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary infection 3458 0
Condition category
Condition code
Physical Medicine / Rehabilitation 3616 3616 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ventilator hyperinflation treatment (VHT). Patients were in side-lying position, so that the more affected lung was upper-most. The ventilatory mode was changed to pressure support ventilation. The pressure support was adjusted above the positive end expiratory pressure to reach 40 cmH2O of peak pressure. The treatment lasted 30 minutes (1 session). All participants received both treatments (intervention and comparator/control) in one day, with a washout period of five hours between them.
Intervention code [1] 3184 0
Treatment: Devices
Comparator / control treatment
Side-lying positioning treatment (SLT). Patients were in side-lying position, so that the more affected lung was upper-most. The treatment consisted of positioning the patient in lateral decubitus for 30 minutes (1 session) without any physiotherapy technique.
Control group
Active

Outcomes
Primary outcome [1] 4508 0
Sputum volume. To the quantification of spuum production, during each treatment, it was collected in a sputum trap collector attached to the closed suction system.
Timepoint [1] 4508 0
At 15 and 30 minutes after interventions commencement.
Secondary outcome [1] 7628 0
Respiratory Mechanics (static compliance of respiratory system and total resistance of respiratory system) were obtained by end inspiratory occlusion method, using respiratory signals from the mechanical ventilator display.
Timepoint [1] 7628 0
At baseline and immediately after interventions.

Eligibility
Key inclusion criteria
Mechanical ventilation, pulmonary infection and hypersecretion.
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Hemodinamic instability, absence of respiratory drive, acute bronchospasm, acute respiratory distress syndrome, atelectasis, immediate postoperative neuro-surgery, untreated pneumothorax, lung hemorrhage, impossibility to keep on lateral decubitus position.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed, opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The random sequence was generated by permuted block randomization.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 1057 0
Brazil
State/province [1] 1057 0

Funding & Sponsors
Funding source category [1] 3639 0
Government body
Name [1] 3639 0
Conselho Nacional de Desenvolvimento Cientifico e Tecnologico (CNPq)/Ministerio da Ciencia e Tecnologia (MCT)
Address [1] 3639 0
SEPN 507, Bloco B, Ed. Sede CNPq
CEP: 70740-901
Brasilia-Distrito Federal
Country [1] 3639 0
Brazil
Funding source category [2] 3640 0
Government body
Name [2] 3640 0
Fundao de Amparo Pesquisa do Estado do Rio de Janeiro (FAPERJ)
Address [2] 3640 0
Avenida Erasmo Braga 118, andar 6
CEP: 20.020-000
Castelo-Rio de Janeiro
Country [2] 3640 0
Brazil
Primary sponsor type
University
Name
Universidade Federal do Rio de Janeiro
Address
Avenida Pedro Calmon 550
Prédio da Reitoria, andar 2
CEP: 21941-90
Cidade Universitária - Rio de Janeiro
Country
Brazil
Secondary sponsor category [1] 3273 0
Hospital
Name [1] 3273 0
Hospital Universitario Clementino Fraga Filho
Address [1] 3273 0
Rua Professor Rodolpho Paulo Rocco 255
Cidade Universitaria - Ilha do Fundao
Rio de Janeiro
CEP: 21941-913
Country [1] 3273 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5693 0
Comite de Etica em Pesquisa (CEP) - Hospital Universitario Clementino Fraga Filho - Universidade Federal do Rio de Janeiro
Ethics committee address [1] 5693 0
Hospital Universitario Clementino Fraga Filho
Rua Professor Rodolpho Paulo Rocco 255
Cidade Universitaria - Ilha do Fundao - Rio de Janeiro
CEP: 21941-913
Ethics committee country [1] 5693 0
Brazil
Date submitted for ethics approval [1] 5693 0
Approval date [1] 5693 0
16/12/2004
Ethics approval number [1] 5693 0
803/04

Summary
Brief summary
The primary purpose of this study was to investigate the effects of a hyperinflation protocol using pressure support ventilation in removing secretions and improving ventilation of hypersecretive critical care patients. We hypothesized that this protocol would improve sputum production and respiratory mechanics, without clinically relevant adverse hemodinamic effects.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28778 0
Address 28778 0
Country 28778 0
Phone 28778 0
Fax 28778 0
Email 28778 0
Contact person for public queries
Name 11935 0
Fernando Guimarães
Address 11935 0
Universidade Federal do Rio de Janeiro
Instituto de Biofísica Carlos Chagas Filho
Ilha do Fundão
CEP: 21941-902
Rio de Janeiro
Country 11935 0
Brazil
Phone 11935 0
+55 21 2562-6557
Fax 11935 0
+55 21 2280-8193
Email 11935 0
fguimaraes@hucff.ufrj.br
Contact person for scientific queries
Name 2863 0
Fernando Guimarães
Address 2863 0
Universidade Federal do Rio de Janeiro
Instituto de Biofísica Carlos Chagas Filho
Ilha do Fundão
CEP: 21941-902
Rio de Janeiro
Country 2863 0
Brazil
Phone 2863 0
+55 21 2562-6557
Fax 2863 0
+55 21 2280-8193
Email 2863 0
fguimaraes@hucff.ufrj.br

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary