The effect of the eucalyptus mist on sore throat, cough and hoarseness after extubation of the endotracheal tube in patients after coronary artery bypass grafting surgery
The aim of this study is to evaluate the effect of eucalyptus vapor on post-extubation cough, hoarseness and sore throat in patients undergone coronary artery bypass surgery. This study is randomized clinical tria. The intervention group,in addithon to usual cares eucalyptus vapor will be used.An indible capsul will be dissolved in 150cc distilled water. An one and twelve hours after extubation, the patients of the intervention group will be asked eucalyptus vapor about ten minutes. . The soret hroat, hoarseness and cough Questionnaire will be also filled out1, 6, 12, and 24 hours after endotracheal extubation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201512147494N16
Registration date:2016-04-22, 1395/02/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-04-22, 1395/02/03
Registrant information
Name
Masoumeh Bagheri Nesami
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 7551
Email address
mbagheri@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Mazandaran University of Medical Science
Expected recruitment start date
2016-02-20, 1394/12/01
Expected recruitment end date
2016-05-09, 1395/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of the eucalyptus mist on sore throat, cough and hoarseness after extubation of the endotracheal tube in patients after coronary artery bypass grafting surgery
Public title
The effect of the eucalyptus mist on sore throat, cough and hoarseness in patients after coronary artery bypass grafting surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria included age of 30-70 years , no history of having cold or sore throat during the preceding week, and lack of drug addiction. Exclusion criteria included more than 1 attempt for intubation intubation and more than 30 seconds, Mallampati score of higher than 2, active airway infection, and history of allergy to eucalyptus. Furthermore, patients who kept in the ICU with an endotracheal tube for more than 16 hours, and patients who were unable to communicate due to different reasons, such as dangerous dysrhythmias, bleeding, loss of consciousness, or any other reason, will be excluded from the study.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical
Street address
Mazandaran University of Medical Sciences, Vice chancellor for research, Moalem street, Moalem square, Sari, Mazandaran, Iran.
City
sari
Postal code
4816715793
Approval date
2015-12-27, 1394/10/06
Ethics committee reference number
IR.MAZUMS.REC.94-1886
Health conditions studied
1
Description of health condition studied
Cough
ICD-10 code
R05
ICD-10 code description
psychogenic cough
2
Description of health condition studied
sore throat
ICD-10 code
J02
ICD-10 code description
acute sore throat
Primary outcomes
1
Description
cough
Timepoint
1, 6, 12 and 24 hrs. after extubation
Method of measurement
four-point scale
2
Description
hoarseness
Timepoint
1, 6, 12 and 24 hrs. after extubation
Method of measurement
four-point scale
3
Description
sore throat
Timepoint
1, 6, 12 and 24 hrs. after extubation
Method of measurement
four-point scale
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group participants were asked one and twelve hours after endotracheal extubation were asked eucalyptus vapor for ten minute
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Fateme Zahra hospitale
Full name of responsible person
Dr Masoumeh Bagheri- Nesami
Street address
Mazandaran University of Medical Sciences, three-way Joibar, highway Basij, Imam square, Sari, Mazandaran, Iran
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research Mazandaran University of Medical Sciences
Full name of responsible person
Dr Ahmad Ali Enayeti
Street address
Vice Chancellor for research Mazandaran University of Medical Sciences, Moalem Street, Moalem Square, Sari, Iran
City
Sari
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 Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Masumeh Bagheri Nesami
Position
PHD/ faculty member
Other areas of specialty/work
Street address
Mazandaran University of Medical Sciences, three-way Joibar, highway Basij, Imam square, Sari, Mazandaran
City
Sari
Postal code
4816715793
Phone
+98 113367551
Fax
Email
anna3043@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
update Mazandaran University of Medical Sciences
Full name of responsible person
Dr Masumeh Bagheri Nesami
Position
PHD/ faculty member
Other areas of specialty/work
Street address
Mazandaran University of Medical Sciences, three way Joibar, highway Basij, Imam square, Sari, Mazand
City
Sari
Postal code
4816715793
Phone
+98 113367551
Fax
Email
anna3043@gmai.com; mbagheri@mazums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)