Protocol summary
-
Study aim
-
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:
IRCT20110514006481N11
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
-
-
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
-
-
Ethics committees
1
-
Ethics committee
-
-
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
1
-
Sponsor
-
-
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
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
-
There is not more information
-
Study Protocol
-
No - There is not a plan to make this available
-
Statistical Analysis Plan
-
No - There is not a plan to make this available
-
Informed Consent Form
-
No - There is not a plan to make this available
-
Clinical Study Report
-
No - There is not a plan to make this available
-
Analytic Code
-
No - There is not a plan to make this available
-
Data Dictionary
-
No - There is not a plan to make this available