Achieving the most effective and least complicated method among four insertion techniques of laryngeal mask airway: standard, 90-degree rotation, 180-degree rotation, and insertion with thumb finger.
Design
Study of a double-blind randomized clinical trial (statistician and patient) on patients undergoing elective surgery requiring anesthesia divided into four groups of at least 63 patients, a total of 252 patients, and randomization with random allocation software
Settings and conduct
A double-blind, randomized, double-blind clinical trial will be performed on 252 patients aged 18 to 80 years with II and ASA I who are candidates for elective surgery. Random allocation will be done using Block Randomization method and Allocation Random software.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 18-80 years; Physical status of the American Society of Anesthesiologists Level I and II.
Exclusion Criteria:
People with difficult airway with mouth opening less than 2.5 cm; People at high risk for aspiration, including non-fasting people with gastroesophageal reflux disease and pregnancy; Patients with a history of sore throat in last month; Colds during the last 10 days; History of head, neck, and stomach surgery; Difficult intubation (mallampati> 3, TMD> 6.5); Coagulopathy
8. BMI> 30
Intervention groups
1. Standard method group
2. 90 degree rotation
3. Rotate 180 degrees
4. Placement with the thumb
Main outcome variables
Evaluation of hemodynamic changes, the success rate in mask placement and complications (laryngospasm, presence of blood on the mask, and sore throat)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190127042511N2
Registration date:2021-11-29, 1400/09/08
Registration timing:registered_while_recruiting
Last update:2021-11-29, 1400/09/08
Update count:0
Registration date
2021-11-29, 1400/09/08
Registrant information
Name
Alireza Babaeizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3669 4561
Email address
alirezabbz@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-11, 1400/08/20
Expected recruitment end date
2021-12-22, 1400/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of four insertion techniques of laryngeal mask airway: standard, 90-degree rotation, 180-degree rotation and insertion with thumb finger
Public title
Comparison of four insertion techniques of laryngeal mask airway: standard, 90-degree rotation, 180-degree rotation and insertion with thumb finger
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
ASA 1 or 2
Age 18 to 80 years
Exclusion criteria:
People with difficult airway with mouth openin less than 2.5 cm
People at high risk for aspiration include non-fasting people with gastroesophageal reflux disease and pregnancy
Patients with a history of sore throat in a recent month
History of head, neck and stomach surgery
Colds in the last 10 days
Difficult intubation (mallampati> 3, TMD> 6.5)
Coagulopathy
BMI>30
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
252
Randomization (investigator's opinion)
Randomized
Randomization description
For the block randomization method, the letter A is used to place patients in the "standard" group, the letter B is used for the "90 degree rotation" group, the letter C is used for the "180 degree rotation" group, and the number D is used for the "thumb placement" group. The size of all blocks is equal and in this four-group experiment, we use 4 blocks (including one person in group A, one person in group B and one person in group C, and one person in group D) that use soft Random sequence generation software will be obtained. Also, in order to hide the random sequence on the participants, opaque sealed envelopes sealed with random sequences are used and each sequence is recorded on a card, and the cards are placed in the envelopes respectively. Based on the order of entry of eligible participants in the research, the envelopes are opened in order and the assigned group of the participant is determined.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients are not aware of being in groups. LMA insertion and data entry is performed by an experienced anesthesiologist. The information analyzer does not know about individuals (coding)
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezar Jerib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-11-02, 1400/08/11
Ethics committee reference number
IR.MUI.MED.REC.1400.611
Health conditions studied
1
Description of health condition studied
Insertion of LMA
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
First try attempt success rate of LMA insertion
Timepoint
After LMA insertion
Method of measurement
Observation
2
Description
Mean arterial pressure
Timepoint
1min before LMA insertion and 1 , 5 min after interion
Method of measurement
NIBP
3
Description
End tidal CO2
Timepoint
After insertion
Method of measurement
Capnography
4
Description
Spo2
Timepoint
Base time (at rest),1min before LMA insertion and 1,5 min after insertion
Method of measurement
Puls oximeter
5
Description
Heart rate
Timepoint
Base time (at rest),1min before LMA insertion and 1,5 min after insertion
Method of measurement
Monitoring
6
Description
Side effects of masking include laryngospasm; blood on the mask; sore throat
Timepoint
When LMA removed
Method of measurement
Observation
7
Description
Calf air pressure need to prevent leakage
Timepoint
After insertion of LMA
Method of measurement
barometer
8
Description
Need for repositioning
Timepoint
At time of insertion
Method of measurement
Observation
9
Description
Attempts for insertion (1,2 or 3 times)
Timepoint
At time of insertion
Method of measurement
Observation
10
Description
Total successful rate of LMA intertion
Timepoint
At time of insertion
Method of measurement
Observation
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Standard method of LMA insertion ; In this method, the LMA mask is inserted using the index finger and advanced to the palatopharyngeal flexion to reach the hypopharynx to finally reach a real resistance.
Category
Treatment - Devices
2
Description
Intervention group: 90 degree rotation method of LMA insertion ؛ In this method, the LMA mask is inserted into the mouth in such a way that its inner layer is towards the buccal mucus and the corner of the mouth. Here the mask is pushed forward to finally hit the resistance.
Category
Treatment - Devices
3
Description
Intervention group: 180 degree rotation method of LMA insertion ؛ In this method, the LMA mask is inserted into the mouth while the inner layer is placed towards the hard palate (contrary to the standard method) and is pushed forward until it encounters resistance. The LMA mask is then rotated 180 degrees and the cuff is inflated.
Category
Treatment - Devices
4
Description
Intervention group: LMA insertion with thumb finger ؛In this method, the anesthesiologist first places the patient on the patient's face in front of the patient's chest and right arm. After partially inflating the cuff (equivalent to half the air recommended for inflating the mask), the posterior surface of the cuff will be lubricated with a blue water-based gel.The patient's head is supported by a tight ring while the patient's neck is flex and the patient's head is extended. The tubular part of the laryngeal mask is held in an automatic manner, and unlike the standard method, the part connected to the tube is taken with the thumb. After opening the patient's mouth, the head of the mask is placed opposite the inner surface of the upper canines, while its opening is towards the front. The mask is then pressed against the hard palate to reach the hypopharyngeal area and resist. In this method, the thumb will be used to apply pressure against the hard palate and push the LMA mask forward
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani hospital
Full name of responsible person
Seyed Jala Hashemi
Street address
Kashani Ave
City
Isfahan
Province
Isfehan
Postal code
۸۳۴۳۴۸۱۸۳۹
Phone
+98 31 3233 0091
Email
Kashanihos@mui.ac.ir
2
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Seyed Jalal Hashemi
Street address
Shohadaye Sofe Ave
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3668 5555
Email
Alzahra@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Seyed Jalal Hashemi
Street address
Hezar Jerib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
Research@mui.ac.ir
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
Seyed Jalal Hashemi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hezarjerib Ave
City
Isfahan
Province
Isfehan
Postal code
8118132554
Phone
+98 31 3224 3652
Email
J_hashemi@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Seyed Jalal Hashemi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hezarjerib Ave
City
Isfahan
Province
Isfehan
Postal code
8118132554
Phone
+98 31 3224 3652
Email
J_hashemi@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Seyed Jalal Hashemi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hezarjerib Ave
City
Isfahan
Province
Isfehan
Postal code
8118132554
Phone
+98 31 3224 3652
Email
J_hashemi@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 is potentially shareable after unidentified individuals
When the data will become available and for how long
Six months after the results were published
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 for access to data by the individual and then review the request by the research assistant within 2 weeks and then permission to access the data.