Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000038998
Ethics application status
Approved
Date submitted
10/01/2011
Date registered
12/01/2011
Date last updated
12/01/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of endotracheal tube on ventilator associated pneumonia in Intensive Care Unit patients
Scientific title
Effect of EVAC endotracheal tube on decreasing ventilator associated pneumonia in critically ill patients admitted to Intensive Care Units
Secondary ID [1] 253371 0
Trial has not a secondary ID.
Universal Trial Number (UTN)
U1111-1118-9359
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pneumonia 260909 0
Condition category
Condition code
Infection 259047 259047 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intubation of patients with EVAC oral endotracheal tube.(A specific tube with a distal lumen for suctioning of subglottic secretions and very thin cuff with poly urethane material which has not any folds on it after cuff filling). Patients will be intubated minimum 3 days until they will meet extubation criteria.
Intervention code [1] 257809 0
Prevention
Comparator / control treatment
Intubation of patients with standard oral endotracheal tubes(Polyvinyl Chloride portex tubes with high volum and low pressure cuff),and will be intubated minimum 3 days until they will meet extubation criteria.
Control group
Active

Outcomes
Primary outcome [1] 259897 0
Ventilator Associated Pneumonia will be assessed by CIPS(Clinically infectione Pulmonary Score).If the score is more than 6 the patient has VAP.
Timepoint [1] 259897 0
During Intensive Care Unit(ICU) stay
Secondary outcome [1] 268784 0
Mortality
Timepoint [1] 268784 0
During Intensive Care Unit Stay

Eligibility
Key inclusion criteria
Adult patients(more than 18 years old) who will be ventilated for more than 3 days
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
previous history of mechanical ventilation,pregnancy, Human Immunodefficiency Virus infection, malignancy,Immunosuppressive therapy, leukocyte count less than 1000/mm3

Study design
Purpose of the study
Prevention
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)
Permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment outside Australia
Country [1] 3133 0
Iran, Islamic Republic Of
State/province [1] 3133 0

Funding & Sponsors
Funding source category [1] 258287 0
University
Name [1] 258287 0
Tabriz University of Medical Sciences
Country [1] 258287 0
Iran, Islamic Republic Of
Primary sponsor type
University
Name
Tabriz University of Medical Sciences
Address
Golgasht street, Tabriz
5157663114
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 257469 0
None
Name [1] 257469 0
Address [1] 257469 0
Country [1] 257469 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260273 0
Ethics committee of Tabriz Medical University
Ethics committee address [1] 260273 0
University of Tabriz,Daneshgah street, Tabriz
515766114
Ethics committee country [1] 260273 0
Iran, Islamic Republic Of
Date submitted for ethics approval [1] 260273 0
Approval date [1] 260273 0
11/12/2010
Ethics approval number [1] 260273 0
5/04/7376

Summary
Brief summary
Almost 10-28% of patients admitted to intensive Care Units(ICU) suffered from Ventilator Associated Pneumonia(VAP) which leads to increasing mortality,ICU length of stay and mortality. As micro or macroaspiration of subglottic secretions is one of the most important risk factors for developing VAP, adevice that can suction these secretion may help to decreasing VAP. So in this study we want to evaluate the efficacy of EVAC endotracheal tube in decreasing VAP in critical ill patients.
ninty patients will be enrolled in this study. patient will be allocated to two 45 patient groups. One group will be intubated with EVAC endotracheal tube and the other group will be intubated with standard tube. the Vap rate, mortality, ICU length of stay and duration of mechanical ventilation will be noted for each patient.
Trial website
there is not any website for trial
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32066 0
Address 32066 0
Country 32066 0
Phone 32066 0
Fax 32066 0
Email 32066 0
Contact person for public queries
Name 15313 0
ata mahmoodpoor
Address 15313 0
General ICU, Shohada hospital,El-Goli ave, Tabriz
5157663114
Country 15313 0
Iran, Islamic Republic Of
Phone 15313 0
00989141160888
Fax 15313 0
Email 15313 0
[email protected]
Contact person for scientific queries
Name 6241 0
Ata Mahmoodpoor
Address 6241 0
General ICU, Shohada hospital,El-Goli ave, Tabriz
Country 6241 0
Iran, Islamic Republic Of
Phone 6241 0
00989141160888
Fax 6241 0
Email 6241 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
SourceTitleYear of PublicationDOI
EmbaseA prospective randomized trial of tapered-cuff endotracheal tubes with intermittent subglottic suctioning in preventing ventilator-associated pneumonia in critically ill patients.2017https://dx.doi.org/10.1016/j.jcrc.2016.11.007
N.B. These documents automatically identified may not have been verified by the study sponsor.