For more than 50 years,uncuffed tracheal tubes(tt)have been the gold standard for intubation in children under the age of 8 yr,however recently has been intrest in the use of cuffed tubes in pediatric practice. The aim of this study was to compare post-extubation stridor and hemo dynamic changes when using cuffed versus uncuffed tubes in children 4-6years old.
In clusion criteria are: the age 4-6 year old and intubation for elective ortheopedic surgery ,or abdomen surgery. Exclusion criteria are parents discontent,coexist disease and surgery's langer than 2 hours. 200 patients age from 4-6 yr are assigned randomly to receive either a cuffed tube or an un cuffed tube . End points are incidence of post-extubation stridor immidiatly after and 5 minutes after extubation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201205269868N1
Registration date:2012-07-09, 1391/04/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-07-09, 1391/04/19
Registrant information
Name
Mohammad Mehdi Zhand
Name of organization / entity
Medical Sience University Ahwaz
Country
Iran (Islamic Republic of)
Phone
+98 21 8898 2226
Email address
zhand.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
University Of Medical Sciences Ahwaz Jondi Shapur
Expected recruitment start date
2012-03-19, 1390/12/29
Expected recruitment end date
2013-02-18, 1391/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison of prevalence of post-extubation strider in cuffed and uncuffed endotracheal tubes in 4-6 years old children
Public title
A comparison of prevalence of post-extubation strider in cuffed and uncuffed endotracheal tubes in 4-6 years old children
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion craiteria : Age 4-6؛ intubion for orthopedic or abdominal surgeries ؛Tracheal at the end of surgeries ؛Extubation at the end of surgeries in operating room ؛Supin position surgeries ؛Elective surgeries ؛asa classI . Exclusioncraiteria : Parets discontent ؛Air way infection ؛Difficult intubation ؛Full stomach ؛Asriration or regorgitation risk ؛Larynx or air way surgery ؛Lung disease. ؛Mecanical ventilation after surgery ؛Surgerymorethan2houres
Age
From 4 years old to 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
University Of Medical Scinces Ahwaz Jondi Shapur
Street address
Ahwaz, Golstan
City
Ahwaz
Postal code
Approval date
2011-09-23, 1390/07/01
Ethics committee reference number
Eth242
Health conditions studied
1
Description of health condition studied
Stridor
ICD-10 code
Jo4.0
ICD-10 code description
Laryngitis
Primary outcomes
1
Description
Stridor
Timepoint
0-5minute
Method of measurement
Observation
Secondary outcomes
1
Description
Respiratory
Timepoint
0-5 minute
Method of measurement
Count
2
Description
Spo2(oxygen percent saturation)
Timepoint
0-5 minute
Method of measurement
Percent
3
Description
Blood pressure
Timepoint
0-5 minute
Method of measurement
Mmhg
Intervention groups
1
Description
using uncuffed tubes after induction of general anesthesia in secend group.
Category
Other
2
Description
Using cuffed tubes after induction of general anesthesia in on group.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam khomeyni hospital , ahwaz
Full name of responsible person
Dr.fateme javaher foroosh
Street address
Avi. 24 metre
City
Ahwaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University Of Medical Sciencec Ahwaz Jondi shapur
Full name of responsible person
Dr.mostafa feghhi
Street address
Golstan
City
Ahwaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University Of Medical Sciencec Ahwaz Jondi shapur
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
University Of Medical Sciences Ahwaz Jondi Shapur
Full name of responsible person
Dr.fateme javaher foroosh zadeh
Position
Anesthesiologist(m.D)/assistant professor
Other areas of specialty/work
Street address
Razi hospital
City
Ahwaz
Postal code
Phone
+98 61 1333 5937
Fax
Email
f-javaher foroosh@
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
University Of Medical Sciences Ahwaz Jondi Shapur
Full name of responsible person
Dr.fatemeh javaher foroosh
Position
Anesthesiologist(m.D)/assistant professor
Other areas of specialty/work
Street address
Razi hospital
City
Ahwaz
Postal code
Phone
+98 61 1333 5937
Fax
Email
f-javaherforoosh@
Web page address
Person responsible for updating data
Contact
Name of organization / entity
university of medicalscieences ahwaz jondi shapur
Full name of responsible person
dr.fatemeh javaherforoosh zadeh
Position
anesthesiologist(m.D)/assistant professor
Other areas of specialty/work
Street address
golestan
City
ahwaz
Postal code
Phone
+98 61 1333 7681
Fax
Email
f-javaherforoosh@
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)