Almost 10-28% of ICU patients suffer from Ventilatory Associated Pnuemonia (VAP) which increases mortality two times and increases length of stay in hospital and cost. As macro or microaspiration of gastric or oropharynx secretions to lower airway due to bacterial colonization of aerodigestive tract is one of the risk factors for VAP, a device that aspirates these secretions can help us. EVAC is a newly designed endotracheal tube which has a dorsal lumen above the cuff for suction of subglottic secretions. As there is not enough evidence about the effect of EVAC tube on reducing VAP, we decided to evaluate the effect of EVAC tube on reducing VAP compared to routine tubes in critically ill patients. After approval of the study in ethics commitee of Tabriz Medical University, 90 patients aging more than 18 year-old which will be intubated more than 72 hours will be entered in this study. Patients will randomly allocated to two 45-patient groups: EVAC group and Standard group. All standard and routine care will be done in patients and all patients will be monitored for VAP and will receive the therapeutic options. Age, sex, APACHE score, Pao2/Fio2, Duration of mechanical ventilation, tracheostomy, reintubation, cuff pressure, number of tube cuff suctioning per day and mortality will be recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201012272582N3
Registration date:2011-01-10, 1389/10/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-01-10, 1389/10/20
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
Tabriz University of Medical Sciences
Expected recruitment start date
2011-01-10, 1389/10/20
Expected recruitment end date
2012-01-10, 1390/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of EVAC tracheal tube in reducing ventilator associated pneumonia in critically patients of intensive care unit
Public title
The effect of endotracheal tube on pneumonia in ICU patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: ICU patients with age more than 18 y. old who will be intubted for more than 72 hours. Exclusion criteria: Previous history of HIV, pregnancy, mechanical ventilation, malignancy, immunosuppresion or leucopenia with leukocyte count less than 1000/mm3.
Age
From 18 years old to 90 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)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz Medical University
Street address
Golgasht street
City
Tabriz
Postal code
Approval date
2012-01-10, 1390/10/20
Ethics committee reference number
5/4/7376
Health conditions studied
1
Description of health condition studied
Pneumonia
ICD-10 code
J09, J10,
ICD-10 code description
Influenza and pneumonia
Primary outcomes
1
Description
ventilatory associated pneumonia
Timepoint
During ICU stay
Method of measurement
CIPS (Clinicaly infectious pulmonary score)
Secondary outcomes
1
Description
Length of ICU stay
Timepoint
During ICU stay
Method of measurement
days of ICU stay
2
Description
mortality
Timepoint
During ICU stay
Method of measurement
being alive or death
Intervention groups
1
Description
Intervention group: patient will be intubated with EVAC endotracheal tubes
Category
Other
2
Description
Control group: patients will be intubated with routin endotracheasl tubes
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
General ICU of Shohada hospital
Full name of responsible person
Ata Mahmoodpoor
Street address
El-goli street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of medical sciences
Full name of responsible person
Alireza Ostad Rahimi
Street address
Faculty of Health and Nutrition
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Alireza Ostadrahimi
Position
Assistant Professor,PhD of Nutrition
Other areas of specialty/work
Street address
Health and Nutrition faculty
City
Tabriz
Postal code
Phone
+98 41 1335 7311
Fax
Email
aostadrahimi@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
Ata Mahmoodpoor
Position
Director of ICU/ Assistant professor/Fellowship of Critical Care Medicine