Comparison of the effects of various pressures of the cuff of the tracheal tube on sore throat and voice violence after general anesthesia
Design
Clinical trials without control group , with parallel groups, one-way blind, random allocation
Settings and conduct
In this clinical trial, the number of patients based on the sample size that was placed in the Gonabad Hospital in 2018-2019 under a general anesthetic under identical conditions was randomly assigned (randomly) into three groups A (cuff pressure of 23 to 20 cm Water), group B (cuff pressure 26-23 cm water) and group c (30-26 cm water). All patients will undergo anesthesia in the same way.
After the patients get the recovery clearance criteria, they are transferred to the department, and the presence and severity of sore throats and post-surgical violence are fixed by one person (nurse section) who are not aware of the grouping of samples at 1, 12 and It will be measured 24 hours after the patient's intelligence and marked in the checklist of the researcher.
Participants/Inclusion and exclusion criteria
1. Patient's complete satisfaction
2. patients under general anesthesia without surgery on the mouth, head and neck.
3. No problems such as airway anomalies , sore throats or violent voice (with the approval of the ENT specialist)
4. 1 or 2 class ASA
5. No Smoking
6.Age is16-65 years old
7. No respiratory and laryngeal diseases
8. Duration of anesthesia between half and two hours
9. Non-use of medicines affecting sore throat and voice violence
Intervention groups
In three groups, the effect of different pressures of the cuff of the tracheal tube on the sore throat and sound violence will be investigated
Main outcome variables
Prevention of two complications of sore throat and voice violence in patients undergoing general anesthesia with a tracheal tube
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190204042616N1
Registration date:2019-03-09, 1397/12/18
Registration timing:registered_while_recruiting
Last update:2019-03-09, 1397/12/18
Update count:0
Registration date
2019-03-09, 1397/12/18
Registrant information
Name
Zahra Sadeghi noghabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5725 2918
Email address
sadeghi.z.stu@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-06, 1397/12/15
Expected recruitment end date
2019-09-06, 1398/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of different cuff pressures of the tracheal tube on sore throat and hoarseness after general anesthesia
Public title
Comparison of the effect of different cuff pressures of the tracheal tube on sore throat and hoarseness after general anesthesia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patient's complete satisfaction
patients under general anesthesia without surgery on the mouth, head and neck
No problems such as airway anomalies , sore throat or violent voice (with the approval of the ENT specialist)
Class 1 or 2 anesthetics according to the ASA
No Smoking
Age is16-65 years old
No respiratory and laryngeal diseases
Duration of anesthesia between half and two hours
Non-use of medicines affecting sore throat and voice violence
Exclusion criteria:
difficult intubation (more than once trying to intubate)
Need for mechanical ventilation after surgery in the intensive care unit
Age
From 16 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
in the form of Permuted block randomization , individuals will be placed in three groups A (cuff pressure 24-20 cm water), group B (cuff pressure 29-25 cm water) and group C (30-34 cm water).
Blinding (investigator's opinion)
Single blinded
Blinding description
Health care personnel (nurses) that responsible for patient care, as well as sore throat and voice assessment after anesthesia, will not be aware of the groups
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Gonabad university of Medical Sciences
Street address
No.5, Taleghani , 12 Taleghani
City
Gonabad
Province
Razavi Khorasan
Postal code
9691639663
Approval date
2019-01-07, 1397/10/17
Ethics committee reference number
IR.GMU.REC.1397.100
Health conditions studied
1
Description of health condition studied
sore throat and voice violence
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Sore throat
Timepoint
1, 12 and 24 hours after surgery
Method of measurement
Visual Analogue Scale
2
Description
Degree of voice violence
Timepoint
1, 12 and 24 hours after surgery
Method of measurement
Researcher checklist made
Secondary outcomes
1
Description
Age
Timepoint
Beginning of study
Method of measurement
Researcher checklist made
2
Description
Sex
Timepoint
Beginning of study
Method of measurement
Researcher checklist made
3
Description
American Society of Anesthesiologists
Timepoint
Beginning of study
Method of measurement
Researcher checklist made
4
Description
Weight
Timepoint
Beginning of study
Method of measurement
Researcher checklist made
5
Description
Intubation time
Timepoint
After intubation
Method of measurement
Researcher checklist made
6
Description
Duration of anesthesia
Timepoint
End of surgery
Method of measurement
Researcher checklist made
Intervention groups
1
Description
Intervention group A:Pressure the cuff tube between 20 to 24 cm of water
Category
Prevention
2
Description
Intervention group B:Pressure the cuff of the trachea tube between 25 to 29 centimeters of water
Category
Prevention
3
Description
Intervention group C: Pressure the cuff of the trachea tube between 30 to 34 centimeters of water
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Bohlool hospital
Full name of responsible person
Zahra sadeghi noghabi
Street address
Saadi Ave , Vahdat Blvd
City
Gonabad
Province
Razavi Khorasan
Postal code
9691639663
Phone
+98 51 5722 5027
Email
sadeghi.noghabi1997@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Ali sagadi
Street address
saadi Ave, Vahdat Blvd, Gonabad university of mddical sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
9691639663
Phone
+98 51 5722 5027
Email
sadeghi.noghabi1997@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Zahra sadeghi noghabi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Anesthesiology
Street address
saadi Ave, Vahdat Blvd, Gonabad university medical sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
9691639663
Phone
+98 51 5722 5027
Email
sadeghi.noghabi1997@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Zahra sadeghi noghabi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Anesthesiology
Street address
Saadi Ave, Vahdat Blvd, Gonabad university medical sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
9691639663
Phone
+98 51 5722 5027
Email
sadeghi.noghabi1997@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Zahra Sadeghi noghabi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Anesthesiology
Street address
No.5 , Taleghani 12, Talaghani Ave
City
Gonabad
Province
Razavi Khorasan
Postal code
9691639663
Phone
+98 51 5725 2918
Fax
Email
sadeghi.z.stu@gmu.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