Comparsion the effects of Echinacea and normalsaline mouthwashes on Ventilator Associated Pneumonia in intubated patients in intensive care units. Arak
Objectives: The objective of this study is to compare the effect of Echinacea and normal saline mouthwash solutions on ventilator associated pneumonia.
Design: This is a randomized clinical trial.
Setting and conduct: Method, time and frequency of mouthwash in both groups will be performed the same way. For diagnosing ventilator associated pneumonia, clinical pulmonary infection score (CPIS) will be completed before and in the fifth day of intervention and the incidence rate of pneumonia will be compared in the two groups.
Participants: Participants are 70 intubated patients admitted to intensive care units of Valiasr hospital in Arak city which were randomly allocated into two intervention and control group groups. Inclusion criteria included having a tracheal tube; aged 18-65 years; less than 12 hours of hospitalization in the intensive care unit; and exclusion criteria included patients transferred from the intensive care unit; patients died before completion of the study; any damage caused by endotracheal intubation or any other physical causes; antibiotic use before admission; admission in other units before intensive care unit; pregnancy; history of allergy to herbal substances; and chronic diseases of immune system.
Intervention: Mouthwash in both groups will be performed the same way, two times a day, for 5 days. Mouthwash in intervention and control groups will be performed with Echinacea and normal saline mouthwash solutions, respectively.
Main outcome measures (variables): The main measure is ventilator associated pneumonia.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014080518694N1
Registration date:2014-10-28, 1393/08/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-10-28, 1393/08/06
Registrant information
Name
Maryam Gholami Mehrabadi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3502
Email address
m.gholami@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Deputy of Arak University of Medical Sciences
Expected recruitment start date
2014-06-22, 1393/04/01
Expected recruitment end date
2015-06-22, 1394/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparsion the effects of Echinacea and normalsaline mouthwashes on Ventilator Associated Pneumonia in intubated patients in intensive care units. Arak
Public title
Effects of Echinacea on Ventilator – Associated Pneumonia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: having a tracheal tube; aged 18-65 years; less than 12 hours of hospitalization in the intensive care unit before.
Exclusion criteria: patients transferred from the intensive care unit; patients died before completion of the study; any damage caused by endotracheal intubation; airway or any other physical cause; antibiotic use before admission; admission in other units before intensive care unit; pregnancy; history of allergy to herbal substances; chronic diseases of immune system.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
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
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Arak University of Medical Sciences
Street address
Arak University of Medical Scienes;Sardasht; street;Arak;Iran
City
Arak
Postal code
3848176941
Approval date
2014-05-21, 1393/02/31
Ethics committee reference number
1100
Health conditions studied
1
Description of health condition studied
Ventilator Associated Pneumonia
ICD-10 code
J17.0
ICD-10 code description
Pneumonia in diseases classified elsewhere
Primary outcomes
1
Description
Ventilator Associated Pneumonia
Timepoint
Before intervention and in the fifth day of intervention
Method of measurement
Clinical Pulmonary Infection Score (CPIS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Echinacea
mouthwash 1%, 30cc,two times a day using a toothbrush for fifth days
Category
Treatment - Drugs
2
Description
Control group: normal saline mouthwash using a toothbrush, 30cc,two times a day using a toothbrush for fifth days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr hospital Arak
Full name of responsible person
Maryam Gholami Mehrabadi
Street address
Valiasr hospital; Valiasr street;Arak;Iran
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Arak University of Medical Sciences
Full name of responsible person
Mr. Babai
Street address
Arak University of Medical Scienes;Sardasht street;Arak;Iran
City
Arak
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