Comparison of Bactiguard endotracheal tubr to Taperguard endotracheal tube in decreasing ventilator associated pneumonia in critically ill patients admitted to intensive care unit
The aim of this study is to determine and compare the incidence of pneumonia in patients under mechanical ventilation and intubated with Bactiguard versus Taperguard endotracheal tube in intensive care unit. A total of 90 critically ill patients over 18 years wxpected to be intubated patients for more than 72 hours, not transferred from another hospital and without the history of mechanical ventilation, will be recruited. Patients will be randomly divided into two groups. One group will be intubated with Taperguard tracheal tube and the other group will be intubated with Bactiguard endotracheal tube. In both groups, the necessary actions will be done to prevent ventilator-associated pneumonia (VAP). All of these patients will be daily monitored regarding the development of VAP, treated in case of VAP and assessed until discharge from the ICU or death.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201601242582N13
Registration date:2016-02-16, 1394/11/27
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-02-16, 1394/11/27
Registrant information
Name
Ata Mahmoodpoor
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 914 116 0888
Email address
mahmoodpoora@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Research deputy of Tabriz University of Medical Sciences
Expected recruitment start date
2016-04-03, 1395/01/15
Expected recruitment end date
2017-09-06, 1396/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Bactiguard endotracheal tubr to Taperguard endotracheal tube in decreasing ventilator associated pneumonia in critically ill patients admitted to intensive care unit
Public title
Comparison of two types of endotracheal tube in decreasing ventilator associated pneumonia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: All patients older than 18 years old requiring mechanical ventilation for more than three days.
Exclusion criteria: transfer from another hospital with a history of mechanical ventilation, pregnancy, HIV, tumor or malignancy, immunosuppressive therapy and leukocyte counts less than 1000 / mm3
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
Golgasht street
City
Tabriz
Postal code
Approval date
2016-01-04, 1394/10/14
Ethics committee reference number
TBZMED.REC.1394.879
Health conditions studied
1
Description of health condition studied
pneumonia
ICD-10 code
J15.9
ICD-10 code description
Bacterial pneumonia, unspecified
Primary outcomes
1
Description
Ventilator Associated Pneumonia
Timepoint
daily untill ischarge
Method of measurement
clinical signs
Secondary outcomes
1
Description
ICU lenghth of stay
Timepoint
daily
Method of measurement
count
2
Description
Duration of mechanical ventilation
Timepoint
daily
Method of measurement
count
3
Description
Mortality
Timepoint
daily
Method of measurement
count
Intervention groups
1
Description
One group will be intubated with Bactiguard tracheal tube.
Size of the tracheal tube will be chosen by the diagnosis of the anesthesiologist and routinely will be 7-7/5 for women and 8 -8/5 for men.
Category
Treatment - Other
2
Description
One group will be intubated with Taperguard tracheal tube.
Size of the tracheal tube will be chosen by the diagnosis of the anesthesiologist and routinely will be 7-7/5 for women and 8 -8/5 for men.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
ICU of Shohada hospital
Full name of responsible person
Ata Mahmoodpoor
Street address
Shohada Hospital, Elgoli street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research deputy of Tabriz University of Medical Sciences
Full name of responsible person
Afshin Ghlehgolab
Street address
Tabriz University of Medical Sciences, Golgasht street
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research deputy of 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
Sarvin Sanaie
Position
Assisstant professor
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences, Golgasht street
City
Tabriz
Postal code
Phone
+98 41 3337 8093
Fax
Email
sanaies@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ata Mahmoodpoor
Position
Associate professor
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences, Golgasht street
City
Tabriz
Postal code
Phone
00
Fax
Email
mahmoodpoora@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hamidreza nouri
Position
Anesthesiology resident
Other areas of specialty/work
Street address
Imam Reza hospital, Golgasht street
City
Tabriz
Postal code
Phone
00
Fax
Email
dr.hamidreza.n@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)