Determination effect of warm Normal saline gargle on sore throat after extubation in open heart surgery patients
Design
In this clinical trial study 60 patients who undergoing open heart surgery will be randomly assigned to intervention and control groups.
Settings and conduct
After transfer to the intensive care unit, if the patient's hemodynamic status will be stable and physician orders for remove the endotracheal tube, patients will be extubated. All patients will be extubated in the same way. For both groups, the numerical pain scale will be filled one hour after extubation. Then, intervention group will be gargle 3۰ cc saline normal solution 40 ° C every 3 hours. There will no intervention for control group.Then, the numerical pain scale will be completed again at 1, 6, 12 and 24 hours after the intervention, for both groups.
Participants/Inclusion and exclusion criteria
Patients undergoing open heart surgery who have the following conditions:
Age 30 to 65 years
Not having a sore throat and a cold in the last week
Ability to communicate
Intubation under 30 seconds
Malapathy score below 2
No use of cricoid pressure method during anesthesia
Intervention groups
In the first hour after extubation and if patient's condition will be instable in the intensive care unit, the numerical scale of pain for both intervention and control groups would be filled. Then, intervention group will be gargle 3۰ cc saline normal solution 40 ° C every 3 hours. There will no intervention for control group.
Main outcome variables
sore throat
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190311043014N1
Registration date:2019-09-13, 1398/06/22
Registration timing:prospective
Last update:2019-09-13, 1398/06/22
Update count:0
Registration date
2019-09-13, 1398/06/22
Registrant information
Name
Golbahar Iri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3461 2575
Email address
golbahar.iri@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2020-03-20, 1399/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of warm Normal saline gargle on sore throat after extubation in open heart surgery patients
Public title
The effect of warm Normal saline gargle on sore throat after extubation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 30-65 years
Not having a sore throat and a cold in the last week
Ability to communicate
Mallampaty score below 2
Don not use of pressure method on cirrhosis during anesthesia
Intubation under 30 seconds
Exclusion criteria:
any attempt to reinstall it
respiratory infection
intubation lasts more than 16 hours in icu
bleeding
dysrhythmia
decreased concsiosness
Age
From 30 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly divided into quadruple groups
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Golestan University of Medical Sciences
Street address
Booyeh Nursing and Midwifery Faculty, Falsafi educational Campus, Beginning of Shast Kola Road, Gorgan
City
Gorgan
Province
Golestan
Postal code
4934174515
Approval date
2019-08-11, 1398/05/20
Ethics committee reference number
IR.GOUMS.RES.1398.177
Health conditions studied
1
Description of health condition studied
sore throat after the CABG
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Sore throat
ICD-10 code
J02.9
ICD-10 code description
Sore throat
Primary outcomes
1
Description
Sore throat
Timepoint
Pre intervention; 1,6,12,24 hours after intervention
Method of measurement
Pain Numerical scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: intervention group will be gargle 3۰ cc saline normal solution 40 ° C every 3 hours. There will no intervention for control group.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralmomenin hospital in the kordkoy
Full name of responsible person
Golbahar iri
Street address
Jangal street, Above the water supply
City
Kordkoy
Province
Golestan
Postal code
4934174515
Phone
+98 17 3245 6900
Email
golbahar.iri@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Mohammad Reza Honarvar
Street address
Shast Kola road, Falsafi campus, Deputy of research and technology
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3245 1660
Email
golbahar.iri@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan 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
Gorgan University of Medical Sciences
Full name of responsible person
Yazdi Khadijeh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shast Kola road, Falsafi Campus, booyeh Nursing and Midwifery school
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3245 6900
Email
yazdi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Yazdi Khadijeh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shast Kola road, Falsafi Campus, booyeh Nursing and Midwifery school
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3245 6900
Email
yazdikh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Golbahar iri
Position
MSN studen
Latest degree
Bachelor
Other areas of specialty/work
Anesthesiology
Street address
Sast Kola road, Falsafi educational campus, Nursing and Midwifery Faculty
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3245 6900
Email
golbahar.iri@gmail.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
The information is confidential for the privacy of the participants
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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be 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
The protocol and analyzing method and the results will be published in the form of a report of the project and the scientific paper
When the data will become available and for how long
3 months after submitting the results to the relevant organization
To whom data/document is available
Academic researchers and for nurses who are working in critical care units
Under which criteria data/document could be used
Just to improve the provision of patient care and research work
From where data/document is obtainable
Khadijeh Yazdi
What processes are involved for a request to access data/document
The request is sent by email to be answered by the research team as soon as possible after review