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Trial registered on ANZCTR
Registration number
ACTRN12608000089336
Ethics application status
Approved
Date submitted
3/02/2008
Date registered
15/02/2008
Date last updated
15/02/2008
Type of registration
Retrospectively registered
Titles & IDs
Public title
An observational study in patients undergoing mechanical ventilation to assess the influence of the adjustments made in the artificial ventilation on the agreement level of pulmonary auscultation (The Kappa analysis)
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Scientific title
An observational study in patients undergoing mechanical ventilation to assess the influence of the adjustments made in the artificial ventilation on the agreement level of pulmonary auscultation (The Kappa analysis)
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
The study was developed with the intention of evaluating the influence of the adjustments made in the artificial ventilation in the intraobserver and interobserver agreement of pulmonary auscultation in patients submitted to artificial ventilation.
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Condition category
Condition code
Respiratory
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0
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Methods: twenty-three patients submitted to artificial ventilation were investigated in the Intensive Care Unit. Three Respiratory Physiotherapists performed the auscultation at three distinct times , regarding the ventilator adjustment (tidal volume 8ml/k8 and 20ml/kg and flow 40l/mim and 80l/mim ), however in a row in the same moment.
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Intervention code [1]
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Not applicable
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Comparator / control treatment
no treatment
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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The interobserver agreement at the best moment of adjustment of the artificial ventilation presented kappa = 0.65 for rhonchi, 0.59 for fine crackles, 0.57 for coarse crackles and 0.36 for bronchial sound.
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Assessment method [1]
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Timepoint [1]
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at 1 year
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Secondary outcome [1]
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The intraobserver agreement level, at the best moment, presented kappa average of 0.62 for rhonchi, 0.82 for coarse crackles, 0.54 for bronchial sound and 0.39 for fine crackles.
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Assessment method [1]
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Timepoint [1]
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at 1 year
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Eligibility
Key inclusion criteria
Older than 18, undergo mechanical ventilation,
positive end expiratory pressure (PEEP) level in mechanical ventilation <6cmH2O
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
barotrauma History and barotrauma Risk
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Study design
Purpose
Natural history
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Duration
Cross-sectional
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Selection
Convenience sample
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
2/02/2008
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
25
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
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Brazil
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State/province [1]
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Bahia
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Funding & Sponsors
Funding source category [1]
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Hospital
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Name [1]
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Paulo Eugenio Oliveira de Souza e Silva
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Address [1]
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Princesa Leopoldina Av, number 404 ed Suzana Ap 304 Cep: 40150080
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Country [1]
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Brazil
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Funding source category [2]
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Hospital
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Name [2]
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Hospital Portugues
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Address [2]
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Princesa Isabel Av, neighborhood: Graca
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Country [2]
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Brazil
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Primary sponsor type
Individual
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Name
Paulo Eugênio Oliveira de Souza e Silva
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Address
Princesa Leopoldina Av, n° 404 ed Suzana Ap 304 Cep: 40150080
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Country
Brazil
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
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Secondary sponsor category [2]
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Individual
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Name [2]
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Antonio Carlos Magualhaes Duarte
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Address [2]
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Vitoria Av, ed Sol Nascente
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Country [2]
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Brazil
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Ethics approval
Ethics application status
Approved
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Summary
Brief summary
Pulmonary auscultation is a important assessment tool in respiratory care. To assess the level of agreement is necessery. The hypothesis is that the way that the ventilator is setting can interfere in the result.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Paulo Eugênio Silva
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Address
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Pincesa Leopoldina Av, n° 407 Ed Suzana
POstal cod 4015080
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Country
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Brazil
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Phone
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7199774907
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Paulo Eugênio Silva
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Address
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Pincesa Leopoldina Av, n° 407 Ed Suzana
POstal cod 4015080
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Country
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Brazil
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Phone
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71 99774907
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Fax
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Email
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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