Comparing prophylactic effects of polyurethane-Cylindric and Tapered cuffed and Polyvinyl chloride cuffed endotracheal tubes in Prevention of ventilator-associated pneumonia on intubated patients in ICU
Objectives)To compare prophylactic effects of polyurethane-Cylindric and Tapered cuffed and Polyvinyl chloride cuffed endotracheal tubes on preventing ventilator-associated pneumonia in intubated patients admitted in ICU. Design) A prospective randomized clinical trial. Participants and settings) Ninety six internal or surgical patients with age range of 18-65 years that have intubated in ICU for first time will randomly allocated in three groups. Patients with intubation before admission in ICU, prior history of immune compromised conditions or pneumonia will exclude from study. Intervention) Intubation will be by polyurethane-Cylindric cuffed endotracheal tubes in group A, polyurethane tapered cuffed in group B and Polyvinyl chloride cuffed in group C. Outcome) All patients will follow for development of ventilator associated pneumonia (VAP).
General information
Acronym
VAP
IRCT registration information
IRCT registration number:IRCT201112163915N4
Registration date:2011-12-21, 1390/09/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-12-21, 1390/09/30
Registrant information
Name
Manizheh Mostafa Gharehbaghi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1526 2253
Email address
peirovifara@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Tabriz University of Medical Sciences
Expected recruitment start date
2011-06-22, 1390/04/01
Expected recruitment end date
2012-03-20, 1391/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing prophylactic effects of polyurethane-Cylindric and Tapered cuffed and Polyvinyl chloride cuffed endotracheal tubes in Prevention of ventilator-associated pneumonia on intubated patients in ICU
Public title
Comparing prophylactic effects of polyurethane-Cylindric and Tapered cuffed and Polyvinyl chloride cuffed endotracheal tubes in Prevention of ventilator-associated pneumonia on intubated patients in ICU
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: intubation in ICU for first time; age range 18-65 years; internal medicine or surgical cases.
exclusion criteria: intubation prior to ICU admission; history of immune compromised conditions; pneumonia.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Gholghasht Street
City
Tabriz
Postal code
Approval date
2011-08-07, 1390/05/16
Ethics committee reference number
5/4/3862
Health conditions studied
1
Description of health condition studied
Ventilator Associated Pneumonia
ICD-10 code
J95.8
ICD-10 code description
Other postprocedural respiratory disorders
Primary outcomes
1
Description
Ventilator associated pneumonia
Timepoint
During hospitalization in ICU
Method of measurement
Chest x-ray (progressive infiltration and consolidation) with two items of body temperature below 36.5 or above 38.5, leukocyte count less than 1500 or more than 10000, purulent tracheal aspirate, positive culture aspirate
Secondary outcomes
empty
Intervention groups
1
Description
group A : intubation with polyurethane-Cylindric cuffed endotracheal tubes,
Category
Treatment - Devices
2
Description
group B: Intubation with polyurethane-Tapered cuffed endotracheal tubes,
Category
Treatment - Devices
3
Description
group C: intubation with Polyvinyl chloride cuffed endotracheal tubes
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada Hospital
Full name of responsible person
Ali Peirovifar
Street address
Operation room, Emam Reza Hospital, Gholghasht street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Tabriz University of Medical Sciences
Full name of responsible person
Dr Rashidi
Street address
Tabriz university of Medical Sciences, Ghoghasht Street
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ali Peirovifar
Position
Associate Professor of Anesthesiology
Other areas of specialty/work
Street address
Operation Room, Emam Reza Hospital, Gholghasht Street
City
Tabriz
Postal code
Phone
+98 41 1334 7054
Fax
Email
peirovifara@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ali Peirovifar
Position
Associate Professor of Anesthesiology
Other areas of specialty/work
Street address
Operation Room, Emam Reza Hospital, Gholghasht Street
City
Tabriz
Postal code
Phone
+98 41 1334 7054
Fax
Email
Peirovifara@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ali Peirovifar
Position
Associate Professor of Anesthesiology
Other areas of specialty/work
Street address
Operation Room, Emam Reza Hospital, Gholghasht Street
City
Tabriz
Postal code
Phone
+98 41 1334 7054
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)