Evaluation and comparison of success rate in laryngeal mask implantation with three anterior airway maneuvers and classical method
Design
Clinical trial with control group with parallel groups, phase 3 on 110 patients
Settings and conduct
This study is performed in Feyz Hospital in Isfahan. Patients are intubated in two ways and the success rate and complications in both groups will be evaluated and compared with each other.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age between 20 to 80 years, ASA class one and two, weight 40-80 kg, body mass index less than 35, mouth opening at least 25 mm. Exclusion criteria: mouth opening less than 25 mm, pregnancy, supraglottic anatomical abnormalities, neck extension limitation, cervical spine abnormality, dysphagia, sore throat
Intervention groups
Intervention group 1: In this group, patients undergo intubation through the laryngeal mask using three airway maneuvers from the front. After intubation, the success rate of intubation in patients as well as its complications such as laryngospasm are examined by an anesthesiologist. Intervention group 2: In this group, patients undergo intubation through the classic method. After intubation, the success rate of intubation in patients as well as its complications such as laryngospasm are examined by an anesthesiologist.
Main outcome variables
Success rate, complications of intubation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200217046523N15
Registration date:2021-05-05, 1400/02/15
Registration timing:prospective
Last update:2021-05-05, 1400/02/15
Update count:0
Registration date
2021-05-05, 1400/02/15
Registrant information
Name
Aryan Rafiee Zadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3837 1582
Email address
rafieezadeh.a@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-09, 1400/02/19
Expected recruitment end date
2021-06-09, 1400/03/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation and comparison of success rate in laryngeal mask implantation with three anterior airway maneuvers and classical method
Public title
laryngeal mask implantation with three anterior airway maneuvers and classical method
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 20 to 80 years
ASA classification I or II
Weight 40-80 kg
Body mass index less than 35
Mouth opening at least 25 mm
Exclusion criteria:
Mouth opening less than 25 mm
Pregnancy
Supraglottic anatomical abnormalities
Neck extension restrictions
Cervical spine deformity
Dysphagia
Existence of sore throat
Age
From 20 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
110
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of IsfahanUniversity of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jarib Ave., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-04-27, 1400/02/07
Ethics committee reference number
IR.MUI.MED.REC.1400.074
Health conditions studied
1
Description of health condition studied
Anesthesia with laryngeal mask
ICD-10 code
T88.4
ICD-10 code description
Failed or difficult intubation
Primary outcomes
1
Description
Success rate in intubation
Timepoint
After trying to intubate
Method of measurement
Examination
2
Description
Complications of intubation
Timepoint
After trying to intubate
Method of measurement
Examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: In this group, patients undergo intubation through the laryngeal mask using three airway maneuvers from the front. After intubation, the success rate of intubation in patients as well as its complications such as laryngospasm are examined by an anesthesiologist.
Category
Treatment - Other
2
Description
Intervention group 2: In this group, patients undergo intubation through the classic method. After intubation, the success rate of intubation in patients as well as its complications such as laryngospasm are examined by an anesthesiologist.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Feyz hospital
Full name of responsible person
Hamidreza Shetai
Street address
Feyz hospial, Feyz Ave,. Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673118
Phone
+98 31 3668 0048
Email
hamidshetabi@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
Isfahan University of Medical Sciences, Hezar Jarib Ave,. Daneshgah Blvd, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673118
Phone
+98 31 3668 0048
Email
haghjoo.sh@med.mui.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Hamidreza Shetai
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Feyz hospial, Feyz Ave,. Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673118
Phone
+98 31 3668 0048
Email
hamidshetabi@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hamidreza Shetai
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Feyz hospial, Feyz Ave,. Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673118
Phone
+98 31 3668 0048
Email
hamidshetabi@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hamidreza Shetai
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Feyz hospial, Feyz Ave,. Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673118
Phone
+98 31 3668 0048
Email
hamidshetabi@med.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared after people have requested.
When the data will become available and for how long
Six months after publishing the results.
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
Scientific uses
From where data/document is obtainable
Isfahan University of Medical Sciences website
What processes are involved for a request to access data/document
Clear request on the site to access the data by the individual and then review the request by the research assistant within 2 weeks and then allow access to the data.