Comparison of the Success Rate of Airway Management by classic laryngeal mask airway( LMAc) and supraglottic gel mask(I-GEL) in elective orthopedic Surgeries
The aim of this study is comparing the success rate of Laryngeal Mask Airway (LMA) and supraglottic gel airway (IGEL) in managing reliable airway in patients scheduled for elective orthopedic surgery under general anesthesia. Sixty 18-60 years old, ASA I,II patients scheduled for elective surgery, completed NPO time, with time of operation less than 1 hour and acceptable airway characteristics will be included. Morbid obese patients, history of GE reflux with any contraindication for general anesthesia and muscle relaxant injection will be excluded from the study. Patients will be divided in 2 groups. After standard monitoring, the same general anesthesia will be induced in all of them. Three minutes after injection of muscle relaxant LMA or IGEL will be inserted in each group based on the patients' weight. Successful insertion time is expressed from the time of reaching the instrument to lips until the first ventilation of patient with peak airway pressure equal to 15 cm H2O without any air leak (will be recorded in seconds). In the situations of failure in the first attempt, the instrument will be removed and try again, this stages will be done until 3 times. The main outcomes of the study are the number of attempts and the time spent until favorable ventilation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201307284969N7
Registration date:2014-05-11, 1393/02/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-05-11, 1393/02/21
Registrant information
Name
Alireza Pournajafian
Name of organization / entity
Tehran University of Medical Sciense
Country
Iran (Islamic Republic of)
Phone
+98 21 8894 6762
Email address
drpournajafian@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Firoozgar Hospital- Iran University of Medical Sciences
Expected recruitment start date
2012-07-22, 1391/05/01
Expected recruitment end date
2013-07-23, 1392/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Success Rate of Airway Management by classic laryngeal mask airway( LMAc) and supraglottic gel mask(I-GEL) in elective orthopedic Surgeries
Public title
Airway Management by classic laryngeal mask airway( LMAc) or supraglottic gel mask(I-GEL)
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: age between 18 and 60 years, ASA I,II patients scheduled for elective surgery, complete NPO time,time of operation less than 1 hour, airway characteristics: TMD>6 cm, mallampati I,II, mouth opening>2 finger width. Exclusion criteria: NPO time<8 hours, morbid obesity, BMI>30, history of GE reflux, no contraindication for general anesthesia and muscle relaxant injection
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single 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 Iran University of Medical Sciences
Street address
Next to Milad tower, Hemmat highway
City
Tehran
Postal code
Approval date
2014-04-26, 1393/02/06
Ethics committee reference number
374/105/د/93
Health conditions studied
1
Description of health condition studied
maintain reliable airway with different instruments in leg fractures
ICD-10 code
s82.9
ICD-10 code description
Fracture of lower leg, part unspecified
Primary outcomes
1
Description
success in patient ventilation without air leak
Timepoint
after instrument insertion
Method of measurement
Questionnaire
2
Description
Time spent to maintain reliable airway
Timepoint
after instrument insertion
Method of measurement
Questionnaire
Secondary outcomes
1
Description
post surgical sore throat
Timepoint
after the operation in recovery room
Method of measurement
recording by questionnaire
2
Description
hoarseness
Timepoint
after the operation in recovery room
Method of measurement
recording by questionnaire
Intervention groups
1
Description
Insertion of supraglottic gel airway (IGEL) for maintaining airway(intervention2) made by Intersurgical company, united kingdom
Category
Treatment - Other
2
Description
insertion of Laryngeal Mask Airway for maintaining airway(intervention1) made by Huiyan company, china
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Foroozgar Hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor of research,Iran University of Medical Sciences
Full name of responsible person
Dr. Morteza Naserbakht
Street address
Iran University of Medical Sciences- Hemmat Highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor of research,Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences- Firoozgar Hospital