Protocol summary

Study aim
Comparison of two methods of LMA insertion,Classic method and using a Laryngoscope.
Design
Clinical trial with parallel groups, including two groups by stratified random method and a total of four strata, in each stratum random permutation block method is used. Randomization tool: table of random numbers. Blinding: not used. Sample size: 106 people.
Settings and conduct
Patients are included in the study based on the inclusion criteria and are divided into two groups of 53 people with stratified random technique. Classes are made based on age group and gender (four classes in total). Within each class, the method of random permutations is used to assign patients to two groups. The randomization tool will be a table of random numbers. In the first group, LMA is implanted in the classical way, in the second group, LMA is implanted using a laryngoscope. In the research, it is done in Ashair hospital of Khorramabad.blinding was not used.
Participants/Inclusion and exclusion criteria
Conditions for entering the study:1.Elective surgery patients in Khorramabad Ashayer Hospital ,in 2023 2.Patients with ASA class 1 and 2. 3.Patients with minor surgery. 4.Patients aged 18 to 65 years 5.Informed patients with written consent Conditions of not entering the study: 1.Patients with head and face injuries and head and neck abnormalities 2.Patients who have contraindications for LMA placement: such as high risk of aspiration, not fasting, pregnancy 3.Patients with difficult Airway
Intervention groups
1. Classic method, 2.using a laryngoscope.
Main outcome variables
comparison of the complications of LMA placement: presence of blood on the LMA, presence of air in the stomach, tooth damage, severity of sore throat( VAS criterion); comparison of LMA insertion time; The number of attempts to successfully insert LMA; level of doctor's satisfaction

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230716058802N1
Registration date: 2023-07-29, 1402/05/07
Registration timing: prospective

Last update: 2023-07-29, 1402/05/07
Update count: 0
Registration date
2023-07-29, 1402/05/07
Registrant information
Name
Aram Azizi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3321 5410
Email address
aram.azizi0212@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-05, 1402/05/14
Expected recruitment end date
2023-09-05, 1402/06/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two methods of LMA insertion,Classic method and using a Laryngoscope.
Public title
Comparison of two methods of Laryngeal Mask Airway insertion,Classic method and using a Laryngoscope.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Elective surgery patients in Khorramabad Ashayer Hospital ,in 1402, Patients with ASA class 1 and 2. Patients with minor surgery. Patients aged 18 to 65 years Informed patients with written consent
Exclusion criteria:
Patients with head and face injuries and head and neck abnormalities Patients who have contraindications for LMA placement: such as high risk of aspiration, not fasting, pregnancy Patients with difficult Airway
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 106
Randomization (investigator's opinion)
Randomized
Randomization description
Based on consecutive non-probability sampling, based on the order of hospitalization, eligible patients are sampled. In this way, the classes are made based on the age groups and gender of the patient (four classes in total). Within each class, random permutation block method is used to assign to two groups. The random tool will also be a table of random numbers. Due to the nature of the anesthesia technique, it was not used in this research. The initial sample size was 44 people in each group using the variable of pain severity and based on the statistical formula, and finally, taking into account the probability of 20% dropout, the final sample size was 53 people in each group (106 in total).
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
Ethic committee of Lorestan University of Medical Sciences
Street address
Dorud Khorramabad highway,Kmalvand,Lorestan University of Medical Sciences
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Approval date
2023-07-11, 1402/04/20
Ethics committee reference number
IR.LUMS.REC.1402.127

Health conditions studied

1

Description of health condition studied
Comparison of two methods of LMA insertion,Classic method and using a Laryngoscope.
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Number of attempts to successfully insert LMA
Timepoint
After LMA placement
Method of measurement
Observe

2

Description
Duration of placement of LMA
Timepoint
After LMA placement
Method of measurement
Observe

3

Description
Presence of blood on the LMA
Timepoint
After removing the LMA
Method of measurement
Observe

4

Description
Presence of air in the stomach
Timepoint
After removing the LMA
Method of measurement
Abdominal examination

5

Description
Severity of sore throat after surgery based on the VAS criterion
Timepoint
After the surgery is completed and the patient becomes conscious
Method of measurement
interview

6

Description
Tooth damage
Timepoint
After LMA placement
Method of measurement
Observe

7

Description
Doctor's satisfaction rate
Timepoint
After LMA placement
Method of measurement
Interview

Secondary outcomes

empty

Intervention groups

1

Description
Control group: Placing the LMA mask in the classic way: In this method, the LMA mask is inserted into the patient's mouth by the doctor's index finger, and then it is sent to the patient's throat in the hypopharynx area in the form of a midline while in direct contact with the patient's mouth and tongue. so that the tip of the mask is in contact with the esophagus, until it finally reaches a real resistance.
Category
Treatment - Devices

2

Description
Intervention group: placement of LMA using laryngoscope: in this method, first we extend the patient's head back, after opening the patient's mouth, we insert the laryngoscope from the right side of the patient's mouth and open the oral space and after accessing the vision Appropriately, we fix the LMA in its anatomical position in the hypopharynx area. In this method, the patient does not undergo a laryngoscopy and the laryngoscope is used only to open the oral space and have a better view.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Ashayer hospital
Full name of responsible person
Aram Azizi Yousefvand
Street address
No 36, Saba street,Keyo squre
City
Khorramabad
Province
Lorestan
Postal code
6817744491
Phone
+98 66 3321 5410
Email
aram.azizi0212@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Dr Behrooz Farzan
Street address
Lorestan University of Medical Sciences,Kmalvand
City
Khorramabad,
Province
Lorestan
Postal code
6813833946
Phone
+98 66 3312 0133
Email
aram.azizi0212@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Khoram-Abad 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
Khoram-Abad University of Medical Sciences
Full name of responsible person
Aram Azizi
Position
Medical Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No36,Saba street,Keyo squre
City
Khorramabad
Province
Lorestan
Postal code
6817744491
Phone
+98 66 3321 5410
Fax
Email
aram.azizi0212@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Aram Azizi
Position
Medical Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No36, Saba street,Keyo square
City
Khorramabad
Province
Lorestan
Postal code
6817744491
Phone
+98 66 3321 5410
Fax
Email
aram.azizi0212@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Aram Azizi
Position
Medical Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No36, Saba street,Keyo square
City
Khorramabad
Province
Lorestan
Postal code
6817744491
Phone
+98 66 3321 5410
Fax
Email
aram.azizi0212@yahoo.com

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 de-identifying individuals.
When the data will become available and for how long
6 months after the results are published
To whom data/document is available
University researchers
Under which criteria data/document could be used
Scientific use
From where data/document is obtainable
Lorestan University of Medical Sciences website
What processes are involved for a request to access data/document
Clear request of the applicant on the website of Lorestan University of Medical Sciences to access the data and then review the request by the research assistant within 2 weeks and then allow access to the data.
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