Comparison of standard and reverse methods of laryngeal mask airway insertion in pediatric airway managment
Design
A concealed, randomized, One-way blinded, controlled clinical trial with a parallel group design of 68 patients, simple randomization took place (Box of numbers)
Settings and conduct
This study was performed in Shahid Motahari Hospital in Urmia to investigate the effect of anesthesia on laryngeal masks on patients undergoing elective inguinal hernia repair surgery.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Children between six months and fifteen years old, weight 5 to 70 kg, candidates for elective inguinal hernia repair surgery with ASA 1 and ASA2 under general anesthesia
Exclusion criteria: ASA3 patients and above, emergency surgery patients at risk of aspiration of gastric contents
Intervention groups
In the first group, the laryngeal mask was standardized and in the second group, it was installed in reverse.
Main outcome variables
Number of attempts to implant a laryngeal mask, Mucosal damage, Airway pressure, Duration of laryngeal mask implantation, Chest movement
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170516033992N3
Registration date:2020-10-28, 1399/08/07
Registration timing:retrospective
Last update:2020-10-28, 1399/08/07
Update count:0
Registration date
2020-10-28, 1399/08/07
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3222 2010
Email address
karami.t@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2020-01-21, 1398/11/01
Actual recruitment start date
2019-07-23, 1398/05/01
Actual recruitment end date
2020-01-20, 1398/10/30
Trial completion date
2020-01-20, 1398/10/30
Scientific title
Comparison of standard and reverse methods of laryngeal mask airway insertion in pediatric airway managment
Public title
Comparison of laryngeal mask insertion in pediatric airway management
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
elective herniorrhaphy candidates with ASA1 and ASA2
Given permission to participate in the study
Exclusion criteria:
ASA3 and higher patients
patients who require urgent surgery required with the risk of aspiration from the stomach fluids
patients with full stomach and therefore with higher risk of aspiration of fluids
Age
From 6 months old to 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
68
Actual sample size reached:
68
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, simple randomization took place in a way that numbers from 1 to 68 were written separately and put inside a blinded box. For each patient a piece of paper was drawn out. If the number drawn for the patient was even it went to group A and if it was an odd number, patients were attributed to group B.
Blinding (investigator's opinion)
Single blinded
Blinding description
The condition of the study was explained to patients but they weren't told which group they were categorized into. Other than our patients everyone in the patient care team including the doctor, research team, and analyzing and supervising team were informed about the intervention of each patient.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Urmia University of Medical Sciences
Street address
No30., Jahad Sq., Resalat St., Urmia University of Medical Sciences, Urmia, Iran
City
Urmia
Province
West Azarbaijan
Postal code
5715833631
Approval date
2019-05-19, 1398/02/29
Ethics committee reference number
IR.UMSU.REC.1398.048
Health conditions studied
1
Description of health condition studied
Inguinal hernia
ICD-10 code
K40
ICD-10 code description
Inguinal hernia
Primary outcomes
1
Description
Chest movement
Timepoint
Through anesthesia procedure in the operation room
Method of measurement
Observation (No movement, Partially good, Adequately good)
2
Description
Airway pressure
Timepoint
Through anesthesia procedure in the operation room
Method of measurement
Adjustable Pressure Limiting results
3
Description
Time of Laryngeal mask insertion
Timepoint
Through anesthesia procedure in the operation room
Method of measurement
Clock
4
Description
Mucous damage
Timepoint
After extracting the mask
Method of measurement
presence of blood on the mask
5
Description
Times tried to put the laryngeal mask on
Timepoint
In time of getting the mask
Method of measurement
Observation
Secondary outcomes
1
Description
Chest movement
Timepoint
Through anesthesia procedure in the operation room
Method of measurement
Observation (no movement, partially good, adequately enough)
Intervention groups
1
Description
Intervention group: Putting the mask upside down (Holding LMA from the proximal part, the mask was put inversely on the hard palate and was lead into the hypopharynx. then with a rotation of 180-degree counterclockwise, it was lead to the pharynx.
Category
Treatment - Devices
2
Description
Control group: standard laryngeal mask insertion (LMA mask was taken out completely and like holding a pen in the hand it was put inside the mouth and with pressing the index finger, it is lead toward the hard palate, pharynx and larynx.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Urmia Shahid Motahari University Hospital
Full name of responsible person
Tohid Karami
Street address
No30., Jahad Sq., Resalat St., Urmia University of Medical Sciences, Urmia, Iran
City
Urmia
Province
West Azarbaijan
Postal code
5715833631
Phone
+98 44 3348 9752
Fax
+98 44 3345 7287
Email
karami.tohid@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Iraj Mohebbi
Street address
No30., Jahad Sq., Resalat St., Uremia University of Medical Sciences, Uremia, Iran
City
Uremia
Province
West Azarbaijan
Postal code
5715833631
Phone
+98 44 3193 7224
Email
mohebbi_iraj@yahoo.co.uk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Tohid Karami
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
No30., Jahad Sq., Resalat st., Uremia University of Medical Sciences, Uremia, Iran
City
Uremia
Province
West Azarbaijan
Postal code
5715833631
Phone
+98 44 3193 7000
Fax
+98 44 3345 7287
Email
karami.tohid@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Tohid Karami
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
No30., Jahad Sq., Resalat st., Uremia University of Medical Sciences, Uremia, Iran
City
Uremia
Province
West Azarbaijan
Postal code
5715833631
Phone
+98 44 3193 7000
Fax
+98 44 3345 7287
Email
karami.tohid@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Tohid Karami
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
No30., Jahad Sq., Resalat st., Uremia University of Medical Sciences, Uremia, Iran
City
Uremia
Province
West Azarbaijan
Postal code
5715833631
Phone
+98 44 3193 7000
Fax
+98 44 3345 7287
Email
karami.tohid@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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