Success rate of laryngeal mask placement in children using one-way jaw lifting method on oxygenation status during general anesthesia
Design
This study is a randomized clinical trial with control and intervention groups in which the groups are parallel; In this study, 30 children will be randomly divided into two groups and there will be no blinding in the study.
Settings and conduct
In this study, blindness will not be performed and patients, including children aged 2 to 10 years, in the Children's Hospital (Tabriz) after random assignment to control and intervention groups, will be subjected to LMA implantation in two classic methods and unilateral jaw lift. .
Participants/Inclusion and exclusion criteria
Inclusion criteria include: non-emergency surgery candidate and exclusion criteria include: congenital anomalies, cleft palate, patients in need of emergency surgery, patients with gastrointestinal problems.
Intervention groups
For patients in the control group (classic LMA implantation by classical method) will be performed by a skilled anesthesiologist and for patients in the intervention group (unilateral jaw raising, anesthesiologist with unilateral maneuvering maneuver) will perform LMA implantation.
Main outcome variables
The use of LMA placement for mechanical ventilation of ginseng is anesthesia and in this study, a new method will be introduced to improve ventilation and oxygenation.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190325043107N17
Registration date:2020-08-03, 1399/05/13
Registration timing:prospective
Last update:2020-08-03, 1399/05/13
Update count:0
Registration date
2020-08-03, 1399/05/13
Registrant information
Name
Mehdi Khanbabayi Gol
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 7054
Email address
khanbabayimehdi69@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-20, 1399/05/30
Expected recruitment end date
2021-02-18, 1399/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Success rate of laryngeal mask placement in children using one-way jaw lifting method on oxygenation status during general anesthesia
Public title
Successful placement of laryngeal mask in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate for non-emergency surgery
Exclusion criteria:
Congenital anomalies
Cleft palate
Patients in need of emergency surgery
Patients with digestive problems
Age
From 2 years old to 10 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
All participants will be randomly divided into two modes of intervention and control with the help of online statistical software (www.randomizer.org). In this method, a profile will be designed for the study and the people who will enter the study will be written in the people participating in the study and the software will randomly enter that person in one of the two intervention or control groups.
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 Tabriz University of Medical Sciences
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Approval date
2020-07-20, 1399/04/30
Ethics committee reference number
IR.TBZMED.REC.1399.407
Health conditions studied
1
Description of health condition studied
Intubation
ICD-10 code
T88.4
ICD-10 code description
Failed or difficult intubation
Primary outcomes
1
Description
Oxygenation
Timepoint
Every minute for ten minutes
Method of measurement
Viewed by an anesthesiologist
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After induction of anesthesia and the right time to insert the LMA, the left hand lifts the lower jaw from one side by performing a JT maneuver, then puts the laryngeal mask in the mouth and pushes it down, and after confirming that it is fixed in place. Proves.
Category
Treatment - Devices
2
Description
Control group: Embedding LMA in this group will be a classic method. The anesthetized patient's head is extended with one hand and the proximal part of the LMA is held in the hand and enters the patient's mouth with the slit surface toward the base of the tongue, then pushed down until resistance is felt. Don't be. The dominant hand is then pushed with the finger guide. Before removing the finger from the patient's mouth, remove the non-dominant hand from under the patient's head and hold the LMA so that it does not move, and then we will fix it.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Childrens Hospital
Full name of responsible person
Masoud Patish
Street address
Sheshgelan Ave, Childrens Hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3535 3696
Email
mkhanbabayi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolghasem Jouyban
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Phone
+98 41 3335 7310
Email
Ajouyban@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
50
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
Tabriz University of Medical Sciences
Full name of responsible person
Masoud Parish
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Childrens Hospital, Sheshgelan Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3334 7054
Fax
Email
Khanbabayimehdi69@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Khanbabayi Gol
Position
MSc in Nursing Education
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3334 7054
Fax
Email
Khanbabayimehdi69@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Khanbabayi Gol
Position
MSc in Nursing Education
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3334 7054
Fax
Email
Khanbabayimehdi69@gmail.com
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 no more information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available