This is a single blind clinical trial to evaluate the effect of eucalyptus nebulized on microbial contamination of endotracheal tube plaque in ventilated patients in Isfahan Alzahra Hospital. Seventy intubated patients will be selected according to inclusion and exclusion criteria with purposive sampling and will be randomly divided into intervention (eucalyptus inhalation) and control groups (normal saline inhalation). Once patients intubated, they will receive aerosolized eucalyptus or normal saline (as placebo) every 8 hours through a standard nebulizer until removal the endotracheal tube. Following extubation, a sample will be taken from the end of endotracheal tube lumen by laboratory expert for identification of respiratory pathogens.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014060217955N1
Registration date:2014-08-31, 1393/06/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-08-31, 1393/06/09
Registrant information
Name
Nazanin Amini
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3451 5672
Email address
n.amini@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Deputy of Arak University of Medical Sciences
Expected recruitment start date
2014-08-06, 1393/05/15
Expected recruitment end date
2014-12-06, 1393/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of nebulized Eucalyptus on microbial contamination of endotracheal tube plaque in ventilated patients
Public title
The Effect of Nebulized Eucalyptus on Contamination of Microbial Plaque of Endotracheal Tube
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:oral intubation;18-65 years old; lack of pulmonary infection; allergy to herbal compounds; sepsis;
pulmonary thromboembolism; Atelectasis; GI inflammatory disease; and severe hepatic disease.
Exclusion criteria: discharge or transport from ICU; death; extubation before 72 hours; withdrew from study; Any sudden change in the patient's clinical condition.
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:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization is Simple
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Arak University of Medical Sciences
Street address
Arak University of Medical Sciences, Alamoll Huda Street, Railroad Street
City
Arak
Postal code
Approval date
2014-07-14, 1393/04/23
Ethics committee reference number
93-165-3
Health conditions studied
1
Description of health condition studied
Relation of Microbial Contamination of Plaque of Endotracheal Tube with Respiratory Pathogens
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Type of Microorganisms
Timepoint
End of Intervention
Method of measurement
Sample Culture by Laboratory Expert
2
Description
Microorganisms Count
Timepoint
End of Intervention
Method of measurement
Samples culture by laboratory expert
Secondary outcomes
empty
Intervention groups
1
Description
Four ml of5% eucalyptus will be diluted in 10 ml normal saline and will be nebulized in about 20 minutes through mechanical ventilator. This work will be performed every 8 hours until extubation.
Category
Prevention
2
Description
Ten ml normal saline will be nebulized in about 20 minutes through mechanical ventilator. This work will be performed every 8 hours until extubation.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan University of Medical Sciences
Full name of responsible person
DrAhmadrezaYazdannik
Street address
Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Azadi Square, Hezar-Jerib street, Isfahan
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Deputy of Arak University of Medical Sciences
Full name of responsible person
Mr.Babaie
Street address
Faculty of Nursing and Midwifery, Arak University of Medical Sciences,Sardasht,
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy of Arak 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
Arak University of Medical Sciences
Full name of responsible person
Nazanin Amini
Position
Bachelor of Anesthetic
Other areas of specialty/work
Street address
Arak University of Medical Sciences,Alamoll Huda Street,Railroad Street
City
Arak
Postal code
Phone
+98 86 3313 6055
Fax
Email
n.amini@arakmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Korosh Rezaei
Position
Msc in Nursing
Other areas of specialty/work
Street address
Arak University of Medical Sciences,Alamoll Huda Street, Railroad Street
City
Arak
Postal code
Phone
+98 86 3417 3524
Fax
Email
k.rezaei@arakmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Nazanin Amini
Position
Bsc in Anesthetic
Other areas of specialty/work
Street address
Arak University of Medical Sciences, Alamoll Huda Street, Railroad Street,
City
Arak
Postal code
Phone
+98 86 3313 6055
Fax
Email
n.amini@arakmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)