Purpose: Determine the proper length of pediatric endotracheal tube
Design: children under 12 years,sample Size 345,randomze, double blind, placebo-controlled unchecked,single center,with out phase
setting and conduct: At the end of surgery before Extubation fiberoptic bronchoscopy performed to measure karina distance to the upper canine teeth and then extubation and measure vocal cord distance to the upper canine teeth
Inclusion criteria: children under 12 years need orotracheal intubation
Exclusion criteria: children with Anatomic problems in face,neck, airway, lungs
intervention:Choose one of three common formula to estimate the depth of the endotracheal tube in the airway
Primary outcome: depth of endotracheal tube
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015100722309N2
Registration date:2015-12-08, 1394/09/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-12-08, 1394/09/17
Registrant information
Name
Behzad Aliakbari Sharabiani
Name of organization / entity
Tabriz University of Medical Sciences, Faculty of Medicine
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 1994
Email address
aliakbarib@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
investigator
Expected recruitment start date
2015-09-21, 1394/06/30
Expected recruitment end date
2015-11-21, 1394/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Estimation of Proper Length of Orotracheal Intubation tube in children-
Comparison of three common formula with fiberoptic bronchoscope
Public title
The entry level of tube inside the lungs during anesthesia in children
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: children under 12 years old, with ASA class 1 and 2, need to orotracheal intubation
Exclusion criteria: children with Anatomic congenital or acquired problems in face, neck, airway, lungs
Age
From 1 day old to 11 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
345
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization of samples has done with the table of random numbers.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Golgasht st., University of Medical Sciences,Faculty of Medicine
City
Tabriz
Postal code
5136735886
Approval date
2015-11-19, 1394/08/28
Ethics committee reference number
Tbzmed.rec.1394.699
Health conditions studied
1
Description of health condition studied
orotracheal intubation
ICD-10 code
-
ICD-10 code description
-
Primary outcomes
1
Description
depth of endotracheal tube
Timepoint
During intervention
Method of measurement
fiberoptic bronchoscope-centimeter
Secondary outcomes
empty
Intervention groups
1
Description
Choose one of three common formula to estimate the depth of the endotracheal tube in the airway.
in this study depth of the orotracheal tube was calculated by one of three common formula and then intubated.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Children's Hospital
Full name of responsible person
Behzad Aliakbari Sharabiani-Assistant Professor of anesthesiology
Street address
Sheshgilan street- Children Hospital
City
tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
abootorab shahmohammadi
Full name of responsible person
abootorab shahmohammadi
Street address
Sheshgilan street - Children Hospital
City
tabriz
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
abootorab shahmohammadi
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
Tabriz Medical University -Faculty of Medicine
Full name of responsible person
abootorab shahmohammadi
Position
medical student
Other areas of specialty/work
Street address
Sheshgilan street - Children Hospital
City
tabriz
Postal code
5136735886
Phone
+98 41 3526 2250
Fax
+98 335262279
Email
Dr.shahmohammadie@gmail.com
Web page address
http://childrenhospital.tbzmed.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz Medical University -Faculty of Medicine
Full name of responsible person
behzad aliakbari sharabiani
Position
Assistant Professor of anesthesiology
Other areas of specialty/work
Street address
Sheshgilan- Children Hospital
City
tabriz
Postal code
5136735886
Phone
+98 41 3526 2250
Fax
+98 335262279
Email
sharabiani48@gmail.com
Web page address
http://childrenhospital.tbzmed.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Tabriz Medical University -Faculty of Medicine
Full name of responsible person
abootorab shahmohammadi
Position
Medical Student
Other areas of specialty/work
Street address
Children Hospital
City
tabriz
Postal code
5136735886
Phone
+98 41 3526 2250
Fax
+98 335262279
Email
Dr.shahmohammadie@gmail.com
Web page address
http://childrenhospital.tbzmed.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)