The Comparison of three methods of endotracheal tube cuff pressure regulation in patients with mechanical ventilation on incidence of ventilator-associated pneumonia
Purpose of this study is the comparison of three methods of regulation in endotracheal tube cuff pressure on incidence of ventilator-associated pneumonia. Design of study: This is a randomized, single blind trial with three groups. Inclusion criteria: patients aged 18-65 years, orotracheal tube, and expectation for mechanical ventilation more than 72 hours. Exclusion criteria: tracheostomy tube, death or disconnection from mechanical ventilation during the study, suppression of immune system, approved pneumonia before the study, massive aspiration, patients with malignancy, reintubation, and changing of cuff pressure out of the design of study. In this study 60 patients will be divided to three groups and will be homogenized about APACHE number and level of consciousness with randomized block design. In group 1 endotracheal tube cuff pressure will be regulated with estimating method by experienced person. In group 2 this regulation will be performed with minimal leak during inspiration and in group 3 endotracheal tube cuff pressure will be regulated with manometer in 25 cmH2o. These interventions are performed twice a day for 4 days. In the first day and fourth day scores of clinical pneumonia are compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201111256481N2
Registration date:2011-12-12, 1390/09/21
Registration timing:prospective
Last update:
Update count:0
Registration date
2011-12-12, 1390/09/21
Registrant information
Name
Mohsen Soleimani
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4190
Email address
soli257@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Semnan University of Medical Sciences
Expected recruitment start date
2012-02-10, 1390/11/21
Expected recruitment end date
2013-06-10, 1392/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison of three methods of endotracheal tube cuff pressure regulation in patients with mechanical ventilation on incidence of ventilator-associated pneumonia
Public title
The Comparison of three methods of endotracheal tube cuff pressure regulation on ventilator-associated pneumonia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Age 18-65 years; Orotracheal tube; Expectation for mechanical ventilation for more than 72 hours. Exclusion criteria: Patients with tracheostomy tube; dying or disconnection from mechanical ventilation before completing study; Immune system suppression; approved pneumonia before start of study; massive aspiration; malignancy; reintubation; change in cuff pressure out of study.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
randomized block design for some features in groups
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences
City
Semnan
Postal code
3513138111
Approval date
2011-11-14, 1390/08/23
Ethics committee reference number
A-10-18-2
Health conditions studied
1
Description of health condition studied
patients with mechanical ventilation
ICD-10 code
J69.0
ICD-10 code description
Pneumonitis due to food and vomit
Primary outcomes
1
Description
Ventilator Associated Pneumonia
Timepoint
Before intervention and 4 days later
Method of measurement
Clinical pneumonia index
Secondary outcomes
1
Description
Administration time in ICU
Timepoint
From administration to discharge
Method of measurement
Counting
Intervention groups
1
Description
Group1: regulation of edotracheal tube cuff pressure with estimation method.
Category
Prevention
2
Description
Group2: regulation of edotracheal tube cuff pressure with minimal leak method.
Category
Prevention
3
Description
Group3: regulation of edotracheal tube cuff pressure with manometer method.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hospital
Full name of responsible person
Dr. Mohsen Soleimani
Street address
Fatemieh Hospital, 17 shahrivar avenue
City
Semnan
2
Recruitment center
Name of recruitment center
Rasool Akram Hospital
Full name of responsible person
Dr. Mohsen Soleimani
Street address
Rasool akram Hospital, Satarkhan avenue
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Raheb Ghorbani
Street address
Semnan University of Medical Sciences, Basij avenue
City
Semnan
Grant name
-
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Dr. Mohsen Soleimani
Position
PhD of nursing
Other areas of specialty/work
Street address
Nursing Faculty, Semnan University of Medical Sciences
City
Semnan
Postal code
3513138111
Phone
+98 23 1335 4190
Fax
Email
soli257@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Mohsen Soleimani
Position
PhD of nursing
Other areas of specialty/work
Street address
Nursing Faculty, Semnan University of Medical Sciences
City
Semnan
Postal code
3513138111
Phone
+98 23 1335 4190
Fax
Email
soli257@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)