Trial Review

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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)
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)
Universal Trial Number (UTN)
Trial acronym
Linked study record

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. 2787 0
Condition category
Condition code
Respiratory 2923 2923 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 2526 0
Not applicable
Comparator / control treatment
no treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3802 0
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.
Timepoint [1] 3802 0
at 1 year
Secondary outcome [1] 6413 0
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.
Timepoint [1] 6413 0
at 1 year

Eligibility
Key inclusion criteria
Older than 18, undergo mechanical ventilation,
positive end expiratory pressure (PEEP) level in mechanical ventilation <6cmH2O
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
barotrauma History and barotrauma Risk

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/02/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment outside Australia
Country [1] 777 0
Brazil
State/province [1] 777 0
Bahia

Funding & Sponsors
Funding source category [1] 3049 0
Hospital
Name [1] 3049 0
Paulo Eugenio Oliveira de Souza e Silva
Country [1] 3049 0
Brazil
Funding source category [2] 3065 0
Hospital
Name [2] 3065 0
Hospital Portugues
Country [2] 3065 0
Brazil
Primary sponsor type
Individual
Name
Paulo Eugênio Oliveira de Souza e Silva
Address
Princesa Leopoldina Av, n° 404 ed Suzana Ap 304 Cep: 40150080
Country
Brazil
Secondary sponsor category [1] 2761 0
None
Name [1] 2761 0
Address [1] 2761 0
Country [1] 2761 0
Secondary sponsor category [2] 2762 0
Individual
Name [2] 2762 0
Antonio Carlos Magualhaes Duarte
Address [2] 2762 0
Vitoria Av, ed Sol Nascente
Country [2] 2762 0
Brazil

Ethics approval
Ethics application status
Approved

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28347 0
Address 28347 0
Country 28347 0
Phone 28347 0
Fax 28347 0
Email 28347 0
Contact person for public queries
Name 11504 0
Paulo Eugênio Silva
Address 11504 0
Pincesa Leopoldina Av, n° 407 Ed Suzana
POstal cod 4015080
Country 11504 0
Brazil
Phone 11504 0
7199774907
Fax 11504 0
Email 11504 0
[email protected]
Contact person for scientific queries
Name 2432 0
Paulo Eugênio Silva
Address 2432 0
Pincesa Leopoldina Av, n° 407 Ed Suzana
POstal cod 4015080
Country 2432 0
Brazil
Phone 2432 0
71 99774907
Fax 2432 0
Email 2432 0
[email protected]

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.