Protocol summary

Summary
The main side effects for intubated patients who hospitalized is ventilator associated pneumonia. The main objective of this study is to find the incidence of ventilator associated pneumonia after using three different devices that are Simple endotracheal tube, Evac tube and bactiguard tube. In this study,180 intubed patients without being diagnosed with pneumonia will choose randomly in emergency department in Loghman hospital. We will divide intubated patients into three groups.We will use simple endotracheal tube for the first one, bactiguard endotracheal tube for second one and Evac endotracheal tube for the third one, for all groups under the study, we will aspirate sub glottal parts each 3 hours , 3 days after starting the intubation ,we will send samples to laboratory for getting culture .All three groups will examine daily for finding pneumonia .If it needs further investigation ,we will order chest x ray then we will categorized patients based on the clinical pulmonary infection score .Finally results those of three groups will be compared for analyzing.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016111430895N1
Registration date: 2016-12-15, 1395/09/25
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-12-15, 1395/09/25
Registrant information
Name
Siamak Moghadam zadeh
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2665 1843
Email address
hajar.dehghan84@gmail.com
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2016-11-21, 1395/09/01
Expected recruitment end date
2017-05-22, 1396/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of intubation with simple endotracheal tube, evac tube and bactiguard tube on incidence of Ventilator-Associated Pneumonia
Public title
Comparision of three types of endotrracheal tubes on incidence of pneumonia
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria: all intubated patients that stay more than 48 hours at Loghman Hakim Hospital exclusion criteria: expiered or extubated patients before 48 hours
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 180
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shahid Beheshty Univercity of Medical Sciences
Street address
Shahid Beheshty Univercity of Medical Sciences, Velenjak
City
Tehran
Postal code
Approval date
2010-05-22, 1389/03/01
Ethics committee reference number
26653785

Health conditions studied

1

Description of health condition studied
pneumonia
ICD-10 code
J67-J70
ICD-10 code description
pneumonitis, due to external agents

Primary outcomes

1

Description
pneumonia
Timepoint
every 6 hours
Method of measurement
clinical and labratory exams

Secondary outcomes

empty

Intervention groups

1

Description
simple endotracheal tubes in control group
Category
Prevention

2

Description
bactiguard endotracheal tubes in first prevention group
Category
Prevention

3

Description
Evac endotracheal tubes in second prevention group
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Loghman Hakim Hospital
Full name of responsible person
Siamak Moghadamzadeh
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Siamak Moghadamzadeh
Street address
Loghman Hakim Hospital
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Siamak Moghadamzadeh
Position
Residense of Emergency Medicine
Other areas of specialty/work
Street address
Loghman Hakim Hospital
City
Tehran
Postal code
Phone
+98 21 5541 9005
Fax
Email
siamak6355@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shaid Beheshti University of Medical Sciences
Full name of responsible person
Mehrdad Taghizadeh
Position
Assisstance professor
Other areas of specialty/work
Street address
Loghman Hakim Hospital, Lashkar Squre, Makhsus Street
City
Tehran
Postal code
Phone
+98 21 5541 9005
Fax
Email
siamak19822012@gamil.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Siamak Moghadamzadeh
Position
Residence of Emergency Medicine
Other areas of specialty/work
Street address
Loghman Hakim Hospital
City
Tehran
Postal code
Phone
00
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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