The effect of usual endotracheal tube replacement with endotracheal tube with capability of subglottic suction on
reduction of ventilator associated pneumonia in patients admitted in adults intensive care units
medical sciences
Objective: To evaluate the effect of usual endotracheal tube replacement with endotracheal tube with capability of subglottic suction on reduction of ventilator associated pneumonia in patients admitted in adults intensive care units.
Study Design: a randomized, double-blind study.
Intervention: 128 patients under mechanical ventilation in the ICU are divided into two groups.
Patients in the control group are under mechanical ventilation with conventional endotracheal tube (7 or 7.5 mm internal diameter for women and 8 or 8.5 mm for men)
In the case group patients' previous tracheal tube to be replaced with tracheal tube with capability of subglottic suction (inner diameter of 7 or 5.7 mm for women or 8 or 8.5 mm for men).
If patients require tracheostomy tube, at the controls we use conventional tracheostomy tube while tracheostomy with capability of subglottic suction in cases.
Inclusion criteria: age over 18; patients with endotracheal tube in the ICU, mechanical ventilation for more than 48 hours, pneumonia before intubation and mechanical ventilation, cardiac disease.
Exclusion criteria: immune deficiency, using immune system inhibitor drugs (cytotoxic chemotherapy or corticosteroids more than 160 mg hydrocortisone, prednisone 40 mg, 6 mg of dexamethasone or its equivalent; extubation less than 48 hours after intubation; death less than 48 hours after intubation, difficult intubation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201509266651N1
Registration date:2016-04-25, 1395/02/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-04-25, 1395/02/06
Registrant information
Name
Mohsen Savaie
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36474270
Email address
savaie@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shiraz University of Medical Science
Expected recruitment start date
2015-10-23, 1394/08/01
Expected recruitment end date
2016-08-22, 1395/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of usual endotracheal tube replacement with endotracheal tube with capability of subglottic suction on
reduction of ventilator associated pneumonia in patients admitted in adults intensive care units
medical sciences
Public title
The effect of usual endotracheal tube replacement with endotracheal tube with capability of subglottic suction on
reduction of ventilator associated pneumonia in patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age over 18; patients with endotracheal tube in the ICU, mechanical ventilation for more than 48 hours, pneumonia before intubation and mechanical ventilation, cardiac disease.
Exclusion criteria: immune deficiency, using immune system inhibitor drugs (cytotoxic chemotherapy or corticosteroids more than 160 mg hydrocortisone, prednisone 40 mg, 6 mg of dexamethasone or its equivalent; extubation less than 48 hours after intubation; death less than 48 hours after intubation, difficult intubation.
Age
From 18 years old to 139 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
128
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
Ethics committee of Shiraz University of Medical Sciences
Street address
Vice Chancellor of research, Shiaz University of Medical Sciences, 7th floor, central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Postal code
Approval date
2015-12-01, 1394/09/10
Ethics committee reference number
IR.SUMS.Med.RED.1394.135
Health conditions studied
1
Description of health condition studied
Pneumonia
ICD-10 code
J15
ICD-10 code description
Bacterial pneumonia, not elsewhere classified
Primary outcomes
1
Description
ventilator associated pneumonia
Timepoint
DAILY
Method of measurement
2015 GUIDLINE ,Centers for Disease Control(CDC)
Secondary outcomes
empty
Intervention groups
1
Description
Patients in the control group are under mechanical ventilation with conventional endotracheal tube (7 or 7.5 mm internal diameter for women and 8 or 8.5 mm for men)
Category
Prevention
2
Description
In the case group patients' previous tracheal tube to be replaced with tracheal tube with capability of subglottic suction (inner diameter of 7 or 5.7 mm for women or 8 or 8.5 mm for men).
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi Hospital
Full name of responsible person
Dr Mohsen Savaie
Street address
Namazi squer, Namazi Hospital
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Shiaz University of Medical Sciences
Full name of responsible person
Dr Seed Basir Hashemi
Street address
Vice chancellor of research,7th floor of central building of Shiraz University of Medical Sciences ,Zand streetl
City
Shiraz
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, Shiaz 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
Shiraz University of Medical Sciences
Full name of responsible person
Mohsen Savaie
Position
Anesthesiologist
Other areas of specialty/work
Street address
Anesthesiology Department- Faghihi Hospital- Zand Street
City
Shiraz
Postal code
Phone
+98 71 3647 4270
Fax
Email
savaie@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University Of Medical Sciences
Full name of responsible person
Dr Farid Zand
Position
Anesthesilogist, ICU fellow ship
Other areas of specialty/work
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Postal code
Phone
+98 71 3647 4270
Fax
Email
zandfarid@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohsen Savaie
Position
Anesthesiologist/ICU fellow ship
Other areas of specialty/work
Street address
General ICU, Namazi squer, Namazi hospital, Zand street
City
Shiraz
Postal code
Phone
+98 71 3647 4270
Fax
Email
savaie@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)