The object of study is to compare the effect of open and close suction system on prevention of Ventilator Associated Pneumonia. After approval of the ethics committee of the Tabriz university of the medical sciences, 96 patients will be recruited. Written informed consents will be obtained from the patients or their relatives. This project will be conducted in General ICUs of Imam Reza and Shohada Hospitals within 14 months.
Patients will be divided into two groups randomly.
In the Open suction group, suction will be performed using single-use catheter as the routine of the wards for maximum of 15 seconds. In the closed suction group, suction will be performed using TYE VARE system and the suction catheter will be replaced every 48 hours. In both groups, prophylaxis standards against VAP will be followed. The following data will be collected for all patients: Gender, age, number of aspirations per day, number of the days being under ventilator, mortality, APACHE score.
VAP diagnosis will be made based on having CIPS criteria (CLINICALLY INFECTION PULMONARY SCORE) while being under mechanical ventilation for 48 hours.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201203072582N6
Registration date:2012-06-27, 1391/04/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-06-27, 1391/04/07
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 chancellor of Tabriz University of Medical Sciences
Expected recruitment start date
2012-06-01, 1391/03/12
Expected recruitment end date
2013-06-01, 1392/03/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effect of open and close endotracheal suctioning on ventilator associated pneumonia in the patients admitted to intensive care unit unit
Public title
Comparison ofeffect of open and closed suctioning in prevention of pneumonia
Purpose
Prevention
Inclusion/Exclusion criteria
Iinclusion criteria: age>18years old; need of mechanical ventilation for at least 48 hours
Exclusion criteria:no satisfaction of patients family
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
96
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 SIENCE
Street address
DESTINATION OF DANESHGAH AVE.
City
TABRIZ
Postal code
Approval date
2012-05-28, 1391/03/08
Ethics committee reference number
9134
Health conditions studied
1
Description of health condition studied
Pneumonia
ICD-10 code
J17
ICD-10 code description
Pneumonia in diseases classified elsewhere
Primary outcomes
1
Description
ventilator associated pneumonia
Timepoint
Days 1 and 2 , days 3 and 4, days 5 to 9, days 10 to 14, days 15 to 19, and days 20 to 24
Days 1 and 2 , days 3 and 4, days 5 to 9, days 10 to 14, days 15 to 19, and days 20 to 24
Method of measurement
being alive or dead
Intervention groups
1
Description
Control group(open suction): suction will be performed by single use routine catheters every one hour during ICU stay. Duration of suction will be less than 15 seconds.
Category
Prevention
2
Description
Intervention group(Closed Suction): suction will be performed with closed system(Tyecare) every one hour during ICU stay.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
SHOHADA HOSPITAL/ICU WARD
Full name of responsible person
Ata Mahmoodpoor
Street address
ELGOLI AVE.
City
TABRIZ
2
Recruitment center
Name of recruitment center
EMAMREZA HOSPITAL/ICU WARD
Full name of responsible person
Ata Mahmoodpoor
Street address
DESTINATION OFDANESHGAH AVE.
City
TABRIZ
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
TABRIZ UNIVERCITY OF MEDICAL SCIENCE
Full name of responsible person
Alireza Ostad Rahimi
Street address
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
TABRIZ UNIVERCITY OF MEDICAL SCIENCE
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
Ata Mahmoodpoor
Position
Assistant Professor,Director of ICU
Other areas of specialty/work
Street address
General ICU,Shohada Hospital, El-goli street
City
Tabriz
Postal code
Phone
+98 41 1385 1117
Fax
Email
amahmoodpoor@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
DR.ATA MAHMOODPOOR
Position
Assistant Professor
Other areas of specialty/work
Street address
General ICU, Shohada Hospital, El-Goli street
City
TABRIZ
Postal code
Phone
+98 41 1385 1117
Fax
Email
amahmoodpoor@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
TABRIZ UNIVERSITY OF MEDICAL SCIENSE
Full name of responsible person
MAJID TAGIZADEH
Position
ASSISTANT OF ANESTHESIOLOGY
Other areas of specialty/work
Street address
Operative room, Emam Reza hospital, Golgasht street
City
TABRIZ
Postal code
Phone
+98 41 1334 7054
Fax
Email
MAJID_53552@YAHOO.COM
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)