Effect of bactiguard infection protection endotracheal tube on ventilator-associated pneumonia occurrence in patients admitted to intensive care unit
Design
This study is clinical trial and double blind.108 patients with ventilator-associated pneumonia in ICU in Valiasr Hospital in Arak will inter this study.We will divide patients in 2 groups by simple randomization.Groups are parallel.
Settings and conduct
This study is clinical trial and double blind.108 patients with ventilator-associated pneumonia in ICU part in Valiasr Hospital in Arak will enter this study.Outcome assessor and analyzer don't aware from grouping.We record leukocytosis, volume of discharge, decrease in oxygen saturation, fever and illness severity.
Participants/Inclusion and exclusion criteria
Inclusion criteria:18 to 60 years; a level of consciousness less than 10
Exclusion criteria: Dissatisfaction
Intervention groups
Patients who enter the first group will receive a bactiguard infection protection endotracheal tube.Patients entering the second group will receive a conventional ordinary endotracheal tube.
Main outcome variables
Leukocytosis, volume of discharge, decrease in oxygen saturation, fever and illness severity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020258N132
Registration date:2020-01-29, 1398/11/09
Registration timing:retrospective
Last update:2020-01-29, 1398/11/09
Update count:0
Registration date
2020-01-29, 1398/11/09
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2019-10-23, 1398/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of bactiguard infection protection endotracheal tube on ventilator-associated pneumonia occurrence in patients admitted to intensive care unit
Public title
Effect of respiratory tube on pneumonia occurrence in patients admitted to intensive care unit
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18 to 60 years
A level of consciousness less than 10
Exclusion criteria:
No history of pulmonary disease
No pulmonary involvement
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
108
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization with randomization with envelopes in two groups A and B .
In this method, we selected a number of cards or letters as an intervention group and the same number of cards for the control group, then the cards were merged. One card was taken out and its allocation was registered and the card was returned to the other cards after leaving. Then the cards are merged again and we remove another card. This process continues to reach a random sequence according to sample size.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double blind. Researcher who complete questionnaire and analyzer and participant are blind (double blind). Outcome assessor and analyzer don't aware from grouping.The person evaluating the outcome is unaware of the grouping. Groups A and B are available to analyzer and outcome assessor.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Of Arak University Of Medical Sciences
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2018-04-29, 1397/02/09
Ethics committee reference number
IR.ARAKMU.REC.1397.024
Health conditions studied
1
Description of health condition studied
ventilator-associated pneumonia
ICD-10 code
J95.851
ICD-10 code description
Ventilator associated pneumonia
Primary outcomes
1
Description
Volume of discharge
Timepoint
Before start intervention and first and second days after intervention
Method of measurement
Milliliter
2
Description
Leukocytosis
Timepoint
Before start intervention and first and second days after intervention
Method of measurement
Blood test
3
Description
Decrease in oxygen saturation
Timepoint
Before start intervention and first and second days after intervention
Method of measurement
Pulse Oximeter
4
Description
Fever
Timepoint
Before start intervention and first and second days after intervention
Method of measurement
Thermometer
5
Description
Illness severity
Timepoint
Before start intervention and first and second days after intervention
Method of measurement
APACHE II score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1:Patients who enter the first group will receive a BIP endotracheal tube (Nova tex Co). The endotracheal tube is inserted into the section from the beginning.The endotracheal tube is made of silver.Bacterial colonization and pneumonia symptoms can be effective. Patients are provided with tracheal tube upon arrival.
Category
Treatment - Devices
2
Description
Intervention group: Patients entering the second group will receive a conventional ordinary endotracheal tube( Nova tex).The endotracheal tube is inserted into the section from the beginning.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Dr Behnam Mahmodie
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Email
mahmodie@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Arak University Of Medical Sciences
Full name of responsible person
Dr Mohammad Arjmandzadegan
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
arjmandzadegan@arakmu.ac.ir
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, Arak University Of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Alireza Kamali
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 68 3222 2003
Fax
+98 86 3222 2003
Email
alikamaliir@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Behnam Mahmodie
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street