Determine the effect of eucalyptus nebulization on arterial blood gas and physiological indexes of ventilated patients
Design
Single blind randomized clinical trial with control group with 35 patients in each group
Settings and conduct
We performed a randomized single blind clinical trial study in three intensive care units of educational hospital. Seventy intubated patients were selected through purposive sampling and randomly divided into intervention and control groups (35 patients in each group). intervention group inhaled eucalyptus and control group inhaled normal saline. At end of study Glasgow Coma Scale and Arterial blood gases and peak inspiratory pressure and tidal volume of mechanical ventilaton device were assessed in both intervention and control groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
oral intubation; 18-65 years old; No pulmonary infection ; No sepsis ; No pulmonary thromboembolism ; No atelectasis; No gasterointestinal inflammatory disease ; No severe hepatic disease; no allergy to herbal compounds.
Exclusion criteria:
-
Intervention groups
Intervention group:
Four ml of 5% eucalyptus Made by Medicinal herbs department in Arak University 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
Vital signs ;Glasgow Coma Scale ;and Arterial blood gases analysis; Some Ventilator Indicators
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180107038251N2
Registration date:2019-07-20, 1398/04/29
Registration timing:retrospective
Last update:2019-07-20, 1398/04/29
Update count:0
Registration date
2019-07-20, 1398/04/29
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
2014-08-11, 1393/05/20
Expected recruitment end date
2014-12-11, 1393/09/20
Actual recruitment start date
2014-08-11, 1393/05/20
Actual recruitment end date
2014-12-11, 1393/09/20
Trial completion date
2014-12-11, 1393/09/20
Scientific title
Effect of nebulized eucalyptus on arterial blood gas and physiologic indexes of ventilated patients:A Double-Blind Randomized Clinical Trial
Public title
Effect of nebulized eucalyptus on arterial blood gas and physiologic indexes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Oral intubation
18-65 years old
Lack of pulmonary infection
No sepsis
No pulmonary thromboembolism
No atelectasis
No gasterointestinal inflammatory disease
No severe hepatic disease
No allergy to herbal compounds
Exclusion criteria:
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
70
Actual sample size reached:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Simple Randomization with tossing a coin method
we used from this method for creating random sequence, so that we considered one of study groups (intervention) as heads and other group (control) as tails and based on sample size we threw the coin and subjects were randomly assigned to two groups
Blinding (investigator's opinion)
Single blinded
Blinding description
For elimination of the possibility of any probable bias due to the knowledge of study Outcome evaluator about the type of treatment we performed a single blind study. Eucalyptus and placebo (normal saline) had the same appearance on the nebulizer device and This device was delivered vapors directly to patient as a fully enclosed enclosure and the evaluator did not notice the smell of eucalyptus in the room ,so Outcome evaluator did not have any knowledge about the type of treatment.
Placebo
Used
Assignment
Parallel
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, Sardasht, Arak Markazi Province
City
Arak
Province
Markazi
Postal code
3848176341
Approval date
2014-07-14, 1393/04/23
Ethics committee reference number
IR.ARAKMU.REC.1393.165.3
Health conditions studied
1
Description of health condition studied
Arterial blood gases analysis in mechanical ventilated patients
ICD-10 code
Z99.1
ICD-10 code description
Dependence on respirator
Primary outcomes
1
Description
PH
Timepoint
Before intervention, three days after the start of intervention (third day),
Method of measurement
The GEM Premier 3000 device is used
2
Description
Hco3
Timepoint
Before intervention, three days after the start of intervention (third day)
Method of measurement
The GEM Premier 3000 device is used
3
Description
base excess
Timepoint
Before intervention, three days after the start of intervention (third day)
Method of measurement
The GEM Premier 3000 device is used
4
Description
Pao2
Timepoint
Before intervention, three days after the start of intervention (third day)
Method of measurement
The GEM Premier 3000 device is used
5
Description
Sao2
Timepoint
Before intervention, three days after the start of intervention (third day)
Method of measurement
The GEM Premier 3000 device is used
6
Description
Paco2
Timepoint
Before intervention, three days after the start of intervention (third day)
Method of measurement
The GEM Premier 3000 device is used
7
Description
Systolic blood pressure
Timepoint
Before intervention, three days after the start of intervention (third day)
Method of measurement
automatic blood pressure from Cardio set x-110 IEI device was used to measure blood pressure
8
Description
Diastolic blood pressure
Timepoint
Before intervention, three days after the start of intervention (third day)
Method of measurement
automatic blood pressure from Cardio set x-110 IEI device was used to measure blood pressure
9
Description
Temperature
Timepoint
Before intervention, three days after the start of intervention (third day)
Method of measurement
thermometer
10
Description
Respiratory rate
Timepoint
Before intervention, three days after the start of intervention (third day)
Method of measurement
respiratory rate per minute
11
Description
pulse rate
Timepoint
Before intervention, three days after the start of intervention (third day)
Method of measurement
pals oximeter
12
Description
level of consciousness
Timepoint
Before intervention, three days after the start of intervention (third day)
Method of measurement
Glasgow Coma Scale
13
Description
peak inspiratory pressure
Timepoint
Before intervention, three days after the start of intervention (third day)
Method of measurement
Ventilator respiratory parameter
14
Description
Tidal volume
Timepoint
Before intervention, three days after the start of intervention (third day)
Method of measurement
Ventilator respiratory parameter
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Four ml of 5% eucalyptus made by medicinal herbs department in arak university 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
Rehabilitation
2
Description
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.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital in Isfahan medical university
Full name of responsible person
Ahmadreza Yazdannik
Street address
Soffeh Blvd, Isfahan, Iran
City
ESfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3668 5555
Email
alzahra@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Alireza Kamali
Street address
Deputy of research and technology,Arak University of Medical Sciences,Basij Sq, Sardasht, Arak ,Markazi Province ,Iran
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3645
Fax
Email
alikamaliir@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Nazanin Amini
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Anesthesiology
Street address
Arak University of Medical Sciences, Alamoll Huda Street, Railroad Street Arak Markazi Province
City
Arak
Province
Markazi
Postal code
٣٨١٩٦٩٣٣٤٥
Phone
+98 34173507
Email
nazaninamini69@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Korosh Rezaei
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Arak University of Medical Sciences, Alamoll Huda Street, Railroad Street Arak Markazi Province
City
Arak
Province
Markazi
Postal code
٣٨١٩٦٩٣٣٤٥
Phone
+98 86 3417 3507
Email
k.rezaei@arakmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Nazanin Amini
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Anesthesiology
Street address
Arak University of Medical Sciences, Alamoll Huda Street, Railroad Street Arak Markazi Province
City
Arak
Province
Markazi
Postal code
٣٨١٩٦٩٣٣٤٥
Phone
+98 86 3417 3507
Email
nazaninamini69@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Partial information about main outcomes are shared
When the data will become available and for how long
After publishing the results
To whom data/document is available
All people have access
Under which criteria data/document could be used
-
From where data/document is obtainable
nazaninamini69@yahoo.com
What processes are involved for a request to access data/document