Determine the effect of nebulized eucalyptus on ventilator associated pneumonia in ventilated patients
Design
Double blind clinical trial with randomized control group with Phase 3
Settings and conduct
This is a double blind clinical trial to evaluate effect of nebulized eucalyptus on ventilator associated pneumonia in ventilated patients in Isfahan Alzahra Hospital. 70 intubated patients are selected according to inclusion and exclusion criteria and randomly with Flip the coin method are assigned to intervention (eucalyptus inhalation) and control groups (normal saline inhalation). Once patients intubated,receive aerosolized eucalyptus or normal saline (as placebo) every 8 hours until removal the endotracheal tube. pneumonia are measured ,by MCPIS checklist. diagnosis of VAP is in association with anesthesiologist. The demographic data (age, sex) and baseline data are recorded in the checklist at the beginning of the study. The followers and evaluators are not aware of the allocation of the groups.
Participants/Inclusion and 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.
Intervention groups
Intevention group:Four ml of 5% 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.
Control group:Ten ml normal saline will be nebulized in about 20 minutes through mechanical ventilator. This work will be performed every 8 hours until extubation.
Main outcome variables
Ventilator associated pneumonia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180107038251N3
Registration date:2019-08-09, 1398/05/18
Registration timing:retrospective
Last update:2019-08-09, 1398/05/18
Update count:0
Registration date
2019-08-09, 1398/05/18
Registrant information
Name
Nazanin Amini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3366 1308
Email address
nazaninamini69@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2014-07-23, 1393/05/01
Expected recruitment end date
2014-11-22, 1393/09/01
Actual recruitment start date
2014-07-23, 1393/05/01
Actual recruitment end date
2014-11-22, 1393/09/01
Trial completion date
2014-11-22, 1393/09/01
Scientific title
Effect of nebulized eucalyptus on ventilator associated pneumonia in ventilated patients
Public title
Effect of nebulized eucalyptus on ventilator associated pneumonia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
18-65 years old
oral intubation
Under ventilation for at least 3 days and up to 14 days
lack of pulmonary infection, sepsis, pulmonary thromboembolism, atelectasis, Gastrointestinal inflammatory disease and severe hepatic disease.
no allergy to herbal compounds
Exclusion criteria:
nasal intubation
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
70
Actual sample size reached:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Simple Randomization with Flip the coin method
we used from this method for creating random sequence, that way we considered one of study groups as milk and other group as line and based on sample size we threw the coin and randomly assigned subjects to two groups
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, participants and evaluators of outcomes of the study are not aware of the allocation of groups
Placebo
Used
Assignment
Other
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
Arak University of Medical Sciences, Alamoll Huda Street, Railroad Street Arak Markazi Province
City
Arak
Province
Markazi
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
Ventilator associated pneumonia
ICD-10 code
J15.9
ICD-10 code description
Unspecified bacterial pneumonia
Primary outcomes
1
Description
Ventilator associated pneumonia
Timepoint
Ventilator associated pneumonia are measured on fifth, ninth day and before extubation.
Method of measurement
Measurement of variables is based on Modified Clinical Pulmonary Infection Score (MCPIS) checklist. The instrument includes five criteria including temperature, white blood cell count, tracheal secretion , oxygenation, chest radiography, each score is 0 to 2, and total score is 10. If total score is equal to or greater than 6, pneumonia is detected
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Four ml of 5% eucalyptus are diluted in 10 ml normal saline and are nebulized in about 20 minutes through mechanical ventilator. This work is performed every 8 hours until extubation
Category
Prevention
2
Description
Control group: Ten ml normal saline are nebulized in about 20 minutes through mechanical ventilator. This work is performed every 8 hours until extubation.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital, Isfahan University of Medical Sciences