Effect of choosing the size of laryngeal mask based on width of tongue on ease of placement, effective ventilation and post-operative sore throat
Design
This study is a randomized clinical trial with control group. In this study, 60 patients according to randomized block design for gender, were selected in two parallel groups (intervention and control). Patients and the persons who collect information are unaware of the type of intervention.
Settings and conduct
This study is carried out in the operating room of the Koosar Hospital in Semnan. Patients are randomly assigned to one of the two groups, intervention (mask selection based on the width of the tongue) and the control (mask size selection based on the patient's weight). Then an experienced person, without being aware of how to choose a laryngeal mask, puts it for the patients and score the ease of placement of it. During surgery the effective ventilation were evaluated. After surgery, the patient's throat irritation score is completed by person who do not know the type of intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age above 18 years, Ability to communicate, ASA class I, II
Exclusion criteria: Weight less than 30 kg, high risk for aspiration, difficult insertion tube with mallampati class IV, Abnormality in larynx
Intervention groups
Intervention group: Choosing the size of the laryngeal mask is based on the patient's tongue width.
Control group: Choosing the size of the laryngeal mask is based on the patient's weight.
Main outcome variables
Ease of placement of laryngeal mask; Effective ventilation; Sore throat
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110514006481N10
Registration date:2019-02-19, 1397/11/30
Registration timing:prospective
Last update:2019-02-19, 1397/11/30
Update count:1
Registration date
2019-02-19, 1397/11/30
Registrant information
Name
Mohsen Soleimani
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4190
Email address
soli257@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-20, 1397/12/01
Expected recruitment end date
2020-05-21, 1399/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of choosing the size of laryngeal mask based on width of tongue on ease of placement, effective ventilation and post-operative sore throat.
Public title
Method of laryngeal mask size selection on post-operative sore throat
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Ability to communicate
Length of surgery less than 2.5 hours
American Society of Anesthesiologists (ASA) class I, II
Exclusion criteria:
Weight less than 30 kg
High risk for aspiration
Difficult insertion tube with mallampati class IV
Abnormality in larynx
Age
From 18 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done using stratified permuted block randomization. Patients are divided into two stratum of women and men. For each stratum, a separate random assignment continues to reach the sample size. For random assignment in each stratum, four blocks of (A, B), which include different states of test and control sequences (AABB, ABAB …), are used. Block selection is done according to a random digits table.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, a person who places a laryngeal mask for patient, as well as the patients and a person who complete the questionnaire are not aware of the type of intervention.
Placebo
Not used
Assignment
Parallel
Other design features
-
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
5th Km Damghan road, Semnan University of Medical Sciences
City
Semnan
Province
Semnan
Postal code
3514753165
Approval date
2018-12-18, 1397/09/27
Ethics committee reference number
IR.SEMUMS.REC.1397.202
Health conditions studied
1
Description of health condition studied
Oedema of larynx
ICD-10 code
J38.4
ICD-10 code description
Oedema of larynx
Primary outcomes
1
Description
Sore throat
Timepoint
After waking up, 1 hour after surgery, 6 hours after surgery
Method of measurement
Numeric Rating Scale
Secondary outcomes
1
Description
Easy insertion of laryngeal mask
Timepoint
After insertion of laryngeal mask
Method of measurement
Visual Analogue Scale
2
Description
Effective ventilation
Timepoint
After insertion of laryngeal mask
Method of measurement
Measurement of expiratory air volume
Intervention groups
1
Description
Intervention group: For these patients, the laryngeal mask selection is performed by matching the largest mask width and the largest portion of the patient's tongue.
Category
Prevention
2
Description
Control group: For these patients, the laryngeal mask selection is performed by the patient's weight.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Koosar Hospital
Full name of responsible person
ِDr Mohsen Soleimani
Street address
Semnan University of Medical Science, 5th Km of Damghan road
City
Semnan
Province
Semnan
Postal code
3514753165
Phone
+98 23 3344 1730
Fax
Email
Soli257@yahoo.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Kookhei
Street address
Semnan University of Medical Sciences, Basij Blvd,
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3344 1730
Email
p_kokha@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Mohsen Soleimani
Position
َAssociate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing Faculty, Semnan University of Medical Sciences, 5th Km of Damghan Road
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3365 4192
Fax
+98 23 1335 4191
Email
soli257@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohsen Soleimani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing faculty, Semnan University of Medical Sciences, 5th Km Damghan road
City
Semnan
Province
Semnan
Postal code
3514753165
Phone
+98 23 3365 4192
Email
Soli257@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohsen Soleimani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing faculty, Semnan University of Medical Sciences, 5th Km of Damghan road
City
Semnan
Province
Semnan
Postal code
3514753165
Phone
+98 23 3365 4192
Email
Soli257@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