Comparison of the laryngoscopic view without the maneuver, Sellick's maneuver and Sellick's maneuver combined with the backward, upward, and rightward pressure on the larynx under general anesthesia during orotracheal intubation in pediatrics aged 2-8 years
Objectives: This study is aimed to compare the laryngoscopic view without maneuver , Sellick's maneuver and Sellick's maneuver combined with the backward, upward, and rightward pressure on the larynx in patients under general anesthesia during orotracheal intubation in pediatrics aged 2-8 years.
Design: Prospective crossover clinical trial.
Setting and conduct : Tertiary regional and teaching hospital.
Participants including major eligibility criteria: One hundred fifty patients candidate for general anesthesia and orotracheal intubation with ASA Class I- II, in Children Medical Center Hospital during 2011-2013,were included .
Intervention: Each patient serving as his or her own control ( without maneuver), Sellick's maneuver, and backward, upward, and rightward pressure.
Main outcome measures (variables): Cormack and Lehane grading, Laryngoscopic view change. Type of maneuver are coded and delivered to the patients by individual not aware of the research process
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201303098435N3
Registration date:2013-03-13, 1391/12/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-03-13, 1391/12/23
Registrant information
Name
Seyed Masoud Hashemi
Name of organization / entity
Department of Anesthesiology and Pain
Country
Iran (Islamic Republic of)
Phone
+98 21 2261 2252
Email address
mohammadinasab@alumnus.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Sciences and Health Services
Expected recruitment start date
2011-04-21, 1390/02/01
Expected recruitment end date
2013-02-19, 1391/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the laryngoscopic view without the maneuver, Sellick's maneuver and Sellick's maneuver combined with the backward, upward, and rightward pressure on the larynx under general anesthesia during orotracheal intubation in pediatrics aged 2-8 years
Public title
Comparison of the laryngoscopic view with Sellick's maneuver and Sellick's maneuver combined with the backward, upward, and rightward pressure on the larynx during orotracheal intubation patients under general anesthesia in pediatrics aged 2-8 years
Purpose
Prevention
Inclusion/Exclusion criteria
Main inclusion criteria: ASA Class I- II; signing consent to parents participate in the study
Main exclusion criteria: Fracture or instability of the cervical spine; Active vomiting; Lesions of the trachea and cricoid; Foreign bodies in the upper airways; Emergency Surgery; History of difficult intubation or airway problems; Morbid obesity; Gastrointestinal obstruction or gastrointestinal disease; Renal failure,uremic, uncontrolled diabetes, and other conditions predisposing to aspiration; Trauma; Anomalies of the head and neck; Cleft lip and palate; Macroglossia
Age
From 2 years old to 8 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Tehran University of Medical Sciences and Health Services
Street address
Poorsina Ave.
City
Tehran
Postal code
Approval date
2011-06-06, 1390/03/16
Ethics committee reference number
p/730
Health conditions studied
1
Description of health condition studied
Cormack and Lehane grade
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
View of laryngeal inlet
Timepoint
Before the maneuver, Sellick's maneuver, Sellick's maneuver combined with the backward, upward, and rightward pressure on the larynx
Method of measurement
Cormack & lehane grading
2
Description
change of laryngeal view
Timepoint
During sellick's maneuver and Sellick's maneuver combined with the backward, upward, and rightward pressure on the larynx
Method of measurement
Cormack & lehane grading
Secondary outcomes
empty
Intervention groups
1
Description
In the study group : Sellick's maneuver and Sellick's maneuver combined with the backward, upward, and rightward pressure on the larynx
Category
Prevention
2
Description
In the control group, Without the maneuver
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Children Medical Center– Hospital
Full name of responsible person
Alireza Ebrahim Soltani
Street address
Keshavarz Blvd, Gharib St.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences and Health Services
Full name of responsible person
Shahin Akhunzadeh MD.
Street address
Poursina St.
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 for research, Tehran University of Medical Sciences and Health Services
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
Children Medical Center– Hospital
Full name of responsible person
Alireza Ebrahim Soltani
Position
Associated Professor
Other areas of specialty/work
Street address
Keshavarz Blvd, Gharib St.
City
Tehran
Postal code
Phone
+98 21 6691 1030
Fax
Email
esoltani@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Children Medical Center– Hospital
Full name of responsible person
Alireza Ebrahim Soltani
Position
Anesthesiologist
Other areas of specialty/work
Street address
Keshavarz Blvd, Gharib St.
City
Tehran
Postal code
Phone
+98 21 6691 1030
Fax
Email
esoltani@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Children Medical Center– Hospital
Full name of responsible person
Alireza Ebrahim Soltani
Position
Associated Professor
Other areas of specialty/work
Street address
Keshavarz Blvd, Gharib St.
City
Tehran
Postal code
Phone
+98 21 6691 1030
Fax
Email
esoltani@sina.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)