Objectives: This study is aimed to compare the laryngoscopic view by cricoid pressure and without cricoid pressure in patients aged 18-80 years under general anesthesia.
Design: Prospective crossover clinical trial.
Setting and conduct : Tertiary regional and teaching hospital.
Participants including major eligibility criteria: ASA Class I- II, undergoing general anesthesia in Farabi Hospital during 2011-2013,were included .
Intervention: Each patient serving as his or her own control, and received cricoid pressure and without cricoid pressure.
Main outcome measures (variables): Cormack and Lehane grading, Laryngoscopic view change.
Type of maneuver are coded and delivered to the patients by and individual not aware of the research process.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201304188435N4
Registration date:2013-05-06, 1392/02/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-05-06, 1392/02/16
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 by cricoid pressure and without cricoid pressure in patients aged 18-80 years under general anesthesia
Public title
comparison of the laryngoscopic view by cricoid pressure and without cricoid pressure
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: ASA Class I- II; signing consent to participate in the study
Exclusion criteria: Anatomic maxillofacial abnormality; Thyromegaly
Age
From 18 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
84
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
Ethics committee of Tehran University of Medical Sciences and Health Services
Street address
Poorsina Ave.
City
Tehran
Postal code
Approval date
2010-06-10, 1389/03/20
Ethics committee reference number
p/20-3-89
Health conditions studied
1
Description of health condition studied
Laryngoscopic view
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
View of laryngeal inlet
Timepoint
Before and after the cricoid pressure
Method of measurement
Cormack & lehane grading
2
Description
change of laryngeal view
Timepoint
Before and after the cricoid pressure
Method of measurement
Cormack & lehane grading
Secondary outcomes
empty
Intervention groups
1
Description
In the study group : Cricoid pressure
Category
Prevention
2
Description
In the control group: Without the cricoid pressure
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Anesthesia department , Farabi Hospital
Full name of responsible person
Anahid Maleki
Street address
Qazvin Sq.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
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
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
Farabi Hospital
Full name of responsible person
Anahid Maleki
Position
Assistant Professor
Other areas of specialty/work
Street address
Qazvin Sq.
City
Tehran
Postal code
Phone
+98 21 5541 9855
Fax
Email
anahidm54@yahoo.com ; a_maleki@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Farabi Hospital
Full name of responsible person
Anahid Maleki
Position
Anesthesiologist
Other areas of specialty/work
Street address
Qazvin Sq.
City
Tehran
Postal code
Phone
+98 21 5541 9855
Fax
Email
a_maleki@tums.ac.ir ; anahidm54@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Farabi Hospital
Full name of responsible person
Anahid Maleki
Position
Assistant Professor
Other areas of specialty/work
Street address
Qazvin Sq.
City
Tehran
Postal code
Phone
+98 21 5541 9855
Fax
Email
a_maleki@tums.ac.ir ; anahidm54@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)