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Differents sellick’s maneuvers on laryngosccopiy view

Protocol summary

Summary
This study was performed to compare the different techniques of cricoid pressure (CP) with regarding to the laryngoscopic view in cesarean section. 142 pregnant woman, aged 18-45 years, ASA I,II, and candidates of elective cesarean section were randomly assigned into 4 groups according to Cricoid Pressure type: A) The index finger over the cricoid cartilage with the thumb and middle finger on the either side, B) The index and middle finger over the cricoid cartilage, with the heel of hand over sternum, C) Hand was placed behind the neck, the index finger over the cricoid cartilage with the thumb and middle finger on the either side, and D) The same as technique C while pillow was placed behind the head. Laryngoscopic view was determined after induction of anesthesia, laryngoscopy and CP. Age, weight, Tyromental Distance (TMD), and teeth status (with or without tooth) were also recorded.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138810142405N4
Registration date: 2010-02-16, 1388/11/27
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2010-02-16, 1388/11/27
Registrant information
Name
Mitra Jabalameli
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1668 7472
Email address
jabalameli@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2005-06-13, 1384/03/23
Expected recruitment end date
2007-02-17, 1385/11/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Differents sellick’s maneuvers on laryngosccopiy view
Public title
Evaluation of differents sellick’s maneuvers on laryngosccopiy view in cesarean section
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Pregnancy, age 18-45 years, ASA I-II, candidates of elective cesarean section, undergoing general anesthesia Exclusion criteria: gross anatomical mandibulo-facial abnormality, cardiovascular diseases, HTN, complicated pregnancy
Age
From 18 years old to 45 years old
Gender
Female
Phase
4
Groups that have been masked
No information
Sample size
Target sample size: 140
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Vice-chancellor for Research, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Approval date
2006-10-24, 1385/08/02
Ethics committee reference number
3851509

Health conditions studied

1

Description of health condition studied
Failed or difficult intubation during pregnancy
ICD-10 code
029.6
ICD-10 code description
Failed or difficult intubation during pregnancy

Primary outcomes

1

Description
Laryngoscopic view
Timepoint
After induction of anesthesia immediately after laryngoscopy ( before and after cricoid pressure( sellick’s maneuver)
Method of measurement
visual of laryngoscopic view by a person (Anesthesiologist)

Secondary outcomes

empty

Intervention groups

1

Description
Cricoid pressure equal to 40 N (Force), from loss of consciousness after injection of IV anesthetic drugs until intubation and inflation of cuff of orotracheal tube. Method: pressure on cricoid cartilage with following technique: the index finger over the cricoid cartilage, with the thumb and middle finger either side
Category
Prevention

2

Description
Cricoid pressure equal to 40 N (Force) from loss of consciousness after injection of IV anesthetic drugs until intubation and inflation of cuff of orotracheal tube. Method: pressure on cricoid cartilage with following technique: The index and middle finger over the cricoid cartilage, with the heel of hand over sternum
Category
Prevention

3

Description
Cricoid pressure equal to 40 N (Force), from loss of consciousness after injection of IV anesthetic drugs until intubation and inflation of cuff of orotracheal tube. Method: pressure on cricoid cartilage with following technique: Hand was placed behind the neck ,the index finger over the cricoid cartilage , with the thumb and middle finger either side
Category
Prevention

4

Description
Cricoid pressure equal to 40 N (Force), from loss of consciousness after injection of IV anesthetic drugs until intubation and inflation of cuff of orotracheal tube. Method: pressure on cricoid cartilage with following technique: Hand was placed behind the neck ,the index finger over the cricoid cartilage , with the thumb and middle finger either side) while pillow was placed behind the head
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Beheshti Medical Center, Isfahan University of Medical Scienes
Full name of responsible person
Dr. Mitra Jabalameli
Street address
Pol Fellezi, Beheshti Medical Center
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Isfahan University of Medical Scienes, Medical School
Full name of responsible person
Zahra Jahanbakhsh
Street address
Vice-chancellor for Research, Medical School, Isfahan University of Medical Sciences
City
Isfahan
Grant name
3851509
Grant code / Reference number
3851509
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Scienes, Medical School
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
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Mitra Jabalameli
Position
Specialist and Associate Professor of Anesthesiology
Other areas of specialty/work
Street address
Pol Fellezi, Beheshti Medical Center
City
Isfahan
Postal code
Phone
+98 31 1236 3600
Fax
+98 31 1236 3600
Email
jabalameli@med.mui.ac.ir
Web page address
www.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Mitra Jabalameli
Position
Medical Doctor (specialist)
Other areas of specialty/work
Street address
Pol Fellezi, Beheshti Medical Center
City
Isfahan
Postal code
Phone
+98 31 1236 3600
Fax
+98 31 1627 3397
Email
jabalameli@med.mui.ac.ir
Web page address
www.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Mitra Jabalameli
Position
Specialist and Associate Professor of Anesthesiology
Other areas of specialty/work
Street address
Pol Fellezi, Beheshti Medical Center
City
Isfahan
Postal code
Phone
+98 31 1236 3600
Fax
+98 31 1627 3397
Email
jabalameli@med.mui.ac.ir
Web page address
www.mui.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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