Evaluation of the diagnostic value of tracheal intubation by two methods of palpation and auscultation compare with chest x-ray in pediatric patients in Chamran Heart Hospital at 2018.
Determination of the diagnostic value of tracheal intubation by two methods of palpation and auscultation compare with chest x-ray in pediatric in Chamran Heart Hospital at 2018
Design
Clinical trial with blank group, simple sampling until completion 80 patients
Settings and conduct
Chamran heart hospital
Participants/Inclusion and exclusion criteria
1- Elective surgery
2- General anesthesia
3- Age under 6 year
Intervention groups
Determine tracheal tube fix number
Main outcome variables
1- Depth of tracheal tube fixation
2- Chest radiographic landmarks
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130430013181N3
Registration date:2020-06-10, 1399/03/21
Registration timing:retrospective
Last update:2020-06-10, 1399/03/21
Update count:0
Registration date
2020-06-10, 1399/03/21
Registrant information
Name
Mojtaba Mansouri
Name of organization / entity
Isfahan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1775 0252
Email address
mansouri@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-21, 1398/01/01
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
2019-04-04, 1398/01/15
Actual recruitment end date
2020-03-10, 1398/12/20
Trial completion date
2020-03-19, 1398/12/29
Scientific title
Evaluation of the diagnostic value of tracheal intubation by two methods of palpation and auscultation compare with chest x-ray in pediatric patients in Chamran Heart Hospital at 2018.
Public title
Pediatric tracheal intubation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. Elective surgery
2. General anesthesia
3. Age under 6 year
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jarib st.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2019-03-03, 1397/12/12
Ethics committee reference number
IR.MUI.MED.REC.1397.288
Health conditions studied
1
Description of health condition studied
Tracheal Intubation
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Fix number of tracheal tube
Timepoint
During tracheal intubation
Method of measurement
Numbers on tracheal tube
Secondary outcomes
1
Description
landmarks of chest x-ray
Timepoint
after surgery
Method of measurement
PACS
Intervention groups
1
Description
Intervention group: All patients anesthetized similarly. They intubated (SOPA Company) by researcher anesthesiologist. For tracheal fixation, physician compress gently suprasternal notch by her recessive hand finger and then pull back tube from trachea by another hand. After palpation of tip of tube, he advanced tube one centimeter in trachea and fixed this against incisors. Number of fixation was recorded in check list. After surgery radiologic landmarks of tracheal tube position were evaluated and recorded.
Category
Treatment - Devices
2
Description
Control group: All patients anesthetized similarly. They intubated (SOPA Company) by researcher anesthesiologist. For tracheal fixation, physician at first auscultate right lung and then during left lung auscultation tracheal tube gently pull back until left lung ventilate too. Then physician further pull back tube 1 centimeter and fixed tracheal tube. Number of fixation was recorded in check list. After surgery radiologic landmarks of tracheal tube position were evaluated and recorded.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Chamran Heart Hospital
Full name of responsible person
Mojtaba Mansouri
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
mansouri@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
sh_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mojtaba Mansouri
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Medical Education
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
8176843555
Phone
+98 31 3775 0252
Email
mansouri@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mojtaba Mansouri
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Medical Education
Street address
Heazar Jarib
City
Isfahan
Province
Isfehan
Postal code
8176843555
Phone
+98 31 3775 0250
Email
mansouri@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mojtaba Mansouri
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Medical Education
Street address
No. 67, Rudaki st. Mahtab build.
City
Isfahan
Province
Isfehan
Postal code
8176843555
Phone
+98 31 3775 0252
Email
mansouri@med.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All of data after patients unrecognizing.
When the data will become available and for how long
One year after print
To whom data/document is available
All of researchers
Under which criteria data/document could be used
Only for medical researchs.
From where data/document is obtainable
Contact with Isfahan medical science research office.
What processes are involved for a request to access data/document
One month after Isfahan medical science research office agreement.