The effect of heating the tip of the endotracheal tube with warm normal saline before intubation in decreasing the prevalence of hoarseness and sore throat after removal of the tube
The effect of heating the tip of the endotracheal tube with warm normal saline before intubation in decreasing the prevalence of hoarseness and sore throat after removal of the tube
Design
A parallel, double-blind clinical trial with parallel groups, randomized by www.randomizer.at website, performed on 58 patients in the two equal groups.
Settings and conduct
This study will be done at Hazrat-e-Rasoul hospital. In the control group (n=29) the normal endotracheal tube will not be heated and in the intervention group (n=29) the endotracheal tube will be heated with normal saline 40 ° C. Eligible patients were randomly divided into two groups of heated endotracheal tube with normal saline 40 degrees Celsius and normal saline using the site https://www.randomizer.at/.
Participants/Inclusion and exclusion criteria
Inclusion criteria were age between 19-63, surgery needed to general anesthesia and lack of cold or throat infections. Exclusion criteria: surgery on the neck and chest, clear hoarseness, previous laryngeal surgery, need for an abnormal position during the operation
Intervention groups
In the control group (n=29) the normal endotracheal tube will not be heated and in the intervention group (n=29) the endotracheal tube will be heated with normal saline 40 ° C.Intervention is not medication and is related to equipment.
Main outcome variables
Sore throat, hoarseness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110213005822N4
Registration date:2021-03-01, 1399/12/11
Registration timing:registered_while_recruiting
Last update:2021-03-01, 1399/12/11
Update count:0
Registration date
2021-03-01, 1399/12/11
Registrant information
Name
Valiollah Hassani
Name of organization / entity
Department of Anesthesiology, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6650 9059
Email address
valiollah_hassani@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-14, 1399/02/25
Expected recruitment end date
2021-06-26, 1400/04/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of heating the tip of the endotracheal tube with warm normal saline before intubation in decreasing the prevalence of hoarseness and sore throat after removal of the tube
Public title
The effect of heating the tip of the endotracheal tube on hoarseness and sore throat
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 19-63
Surgery needed to general anesthesia
Lack of cold or throat infections
Satisfaction to participate in the study
Exclusion criteria:
Surgery on the neck and chest
Clear hoarseness
Previous laryngeal surgery
Need for an abnormal position during the operation
Age
From 19 years old to 63 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
58
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible patients were randomly divided into two groups of heated endotracheal tube with normal saline 40 degrees Celsius and normal saline using the site https://www.randomizer.at/.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients were unaware of being in the intervention groups and remained blind until the end of the study because they are anesthetized , and the statistical analyzer also received the data as a code, not the actual grouping, such as group A for intervention and B for control.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences., next to Milad tower., Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2020-05-09, 1399/02/20
Ethics committee reference number
IR.IUMS.FMD.REC.1399.113
Health conditions studied
1
Description of health condition studied
Sore throat
ICD-10 code
R07.0
ICD-10 code description
Pain in throat
Primary outcomes
1
Description
Sore throat
Timepoint
20 minutes and 24 hours after endotracheal tube removal
Method of measurement
Examination (Yes/no)
2
Description
Hoarseness
Timepoint
20 minutes and 24 hours after endotracheal tube removal
Method of measurement
Examination (Yes/no)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After general anesthesia, in the intervention group (n = 29), the endotracheal tube heated with normal saline 40 ° C (product of Supa company) will be intubated.
Category
Prevention
2
Description
Control group: After general anesthesia, in the control group (n = 29), the normal endotracheal tube (unheated) (product of Supa company) will be intubated.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Rasoul Hospital
Full name of responsible person
Valiollah Hassani
Street address
Niyayesh St, Sattarkhan St.
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6651 5001
Email
valiollah_hassani@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyyed Abas Motavalian
Street address
Fifth floor, Central staff, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1433933111
Phone
+98 21 6650 9059
Email
amotevalian@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Valiollah Hassani
Position
Professor of Anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hazrat Rasoul Medical Center, Niayesh st, Sattarkhan ave
City
Tehran
Province
Tehran
Postal code
1433933111
Phone
+98 21 6650 9059
Fax
+98 21 6650 9059
Email
v-hassani@sina.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Valiollah Hassani
Position
Professor of Anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hazrat Rasoul Medical Center, Niayesh st, Sattarkhan ave
City
Tehran
Province
Tehran
Postal code
1433933111
Phone
+98 21 6650 9059
Fax
+98 21 6650 9059
Email
v-hassani@sina.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Valiollah Hassani
Position
Professor of Anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hazrat Rasoul Medical Center, Niayesh st, Sattarkhan ave
City
Tehran
Province
Tehran
Postal code
1433933111
Phone
+98 21 6650 9059
Fax
+98 21 6650 9059
Email
v-hassani@sina.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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