Our purpose in this study is determine suitable method to select the laryngeal mask size in Iranian women
Design
In this research, 300 women patients referring to Khatam Hospital in Mashhad University of Medical Sciences and candidate for general anesthesia were chosen purposefully and a code was allocated to each one of them. Then, patients were randomly divided into two control and intervention groups.
Settings and conduct
This is a clinical study that was done in Khatam Hospital of Mashhad University of Medical Sciences in 2017.
Participants/Inclusion and exclusion criteria
In this study the patients who were 18 to 70 years old and had ASA physical status 1 to 3 undergoing general anesthesia, were entered in this study.
Intervention groups
The selection mask in control group was selected based on weight (according to the manufacturer's recommended weight of 30-50 kg: size 3, weight 50-70 kg: size 4, weight 70-90 kg: size 5) and intervention group Intervention was selected based on height ( Height below 160 cm: size 3, height 160 cm: size 4) ,respectively.
Main outcome variables
Determine the appropriate classic LMA; Determine the rate of LMA complications
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170216032604N2
Registration date:2018-04-01, 1397/01/12
Registration timing:retrospective
Last update:2018-04-01, 1397/01/12
Update count:0
Registration date
2018-04-01, 1397/01/12
Registrant information
Name
ZOHREH roohandeh
Name of organization / entity
Mashhad univercity medicin center
Country
Iran (Islamic Republic of)
Phone
+98 51 3606 1939
Email address
rouhandehz931@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
mashhad university of medicine
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2017-05-22, 1396/03/01
Actual recruitment start date
2016-05-21, 1395/03/01
Actual recruitment end date
2017-05-22, 1396/03/01
Trial completion date
empty
Scientific title
Determine the proper size of the laryngeal mask according to the weight and height criteria for women
Public title
Determine the proper size of the laryngeal mask according to the weight and height criteria for women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Female
age of 18 to 70 years
General Anesthesia
Candidate for eye surgery
Exclusion criteria:
BMI>40
mouth opening less than 2.5 cm
symptomatic hiatus hernia
Esophageal reflux diseases
recent infection of upper respiratory track
Sore throat
dysphonia/dysphagia
Age
From 18 years old to 70 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
300
Actual sample size reached:
300
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization is done by using closed envelopes.The researcher and the patient do not know the mask size selection criteria.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study is double-blind study, that patients and researcher are unaware from type of selected mask. A pre-selected mask is given to them.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical committee of Mashhad University of Medical Sciences
Street address
Daneshgah St, Ghoreish Building
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2017-02-08, 1395/11/20
Ethics committee reference number
IR.mums.fm.REC.1395.561
Health conditions studied
1
Description of health condition studied
Selection size of Mask
ICD-10 code
T88.5
ICD-10 code description
Other complications of anesthesia
Primary outcomes
1
Description
Approprate LMA
Timepoint
During LMA insertion, recovery and after 24 hours
Method of measurement
Interview based on incidence of complications
Secondary outcomes
1
Description
Complications of LMA
Timepoint
During the mask insertion
Method of measurement
Sore throat
Intervention groups
1
Description
Interventional group: selection size of LMA is based on height
Category
Treatment - Devices
2
Description
Control group:selection size of LMA is based on weight
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatamolanbia Hospital
Full name of responsible person
Zohreh Roohandeh
Street address
Taghiabad Square , Imam Reza (AS) Hospital, Department of َAnesthesiology
City
Mahshad
Province
Razavi Khorasan
Postal code
00985138022608
Phone
+98 51 3802 2712
Email
Z_roohandeh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Mashhad University of Medical Sciences
Full name of responsible person
Mahyar Mirheidari
Street address
Mashhad University of Medical Sciences; International Offic Administration Center (Qoreishi Building) ; Daneshgah St
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2712
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Mashhad 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
Mashhad University Medical Sciences
Full name of responsible person
Zohreh Roohandeh
Position
Consultant of anesthesia
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Emamat 28 st. p 54
City
Mashhad
Province
Razavi Khorasan
Postal code
9188787361
Phone
+98 51 3606 1939
Fax
+98 51 3606 1939
Email
rouhandehz931@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University Medical Sciences
Full name of responsible person
Alireza Bameshki
Position
Assistant prof
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Reza Hospital, Anesthesia Department
City
Mashhad
Province
Razavi Khorasan
Postal code
9188787361
Phone
+98 51 3802 2711
Fax
Email
bameshkiar@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University Medical Sciences
Full name of responsible person
Zohreh Roohandeh
Position
Assistant
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Emamat 28- p 54
City
Mashhad
Province
Razavi Khorasan
Postal code
9188787361
Phone
+98 51 3606 1939
Fax
Email
rouhandehz931@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is 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
Title and more details about the data/document
Spss file
When the data will become available and for how long
2017-2018
To whom data/document is available
Mashhad University of Medical Sciences
Under which criteria data/document could be used
frequency
From where data/document is obtainable
Zohreh Rohandeh
What processes are involved for a request to access data/document
sent an email to Zohreh Rohandeh
email: Z_roohandeh@yahoo.com