comparison of the accuracy value of color Doppler epigastric ultrasound and superficial probe Suprasternal Natch sonography in comparison with standard capnography method in diagnose of tracheal tube location after intubation
Diagnostic value of color Doppler epigastric sonography and sonography with surface probe in suprasutral nuch compared to standard capnography method in Detection of endotracheal tube location
Whereas the findings of this study indicate the high accuracy of sonography to detect the exact location of the endotracheal tube after intubation, This method can be used instead of capnography
Design
Diagnostic clinical trial-No control group-Double blind
Settings and conduct
This study will be conducted in Alzahra and Kashani teaching hospitals in Isfahan. Patients will be selected in an easily accessible non-random way. intubation will be performed by emergency medicine assistants And immediately afterwards, Placed by the assistant in charge of implementing the Caller Doppler ultrasound probe plan on Epigastr .By changing the blue and red due to airflow presence or absence of a tube in the esophagus is determined
surface probe is also transversely in front of the neck in the suprasternal notch.and presence or absence of a tube in the trachea is determined At the same time, the nurse determines the tube location by capnography.Emergency Medicine Assistant Unaware of Capnographic Outcome and Nurse Unaware of Ultrasound Outcome. Ultrasound and capnography results are compared by the assistant in charge with chest x-ray
Participants/Inclusion and exclusion criteria
1-Age over 18 years 2-Emergency hospitalization 3-Requires intubation by RSI 4-Absence of abdominal and thoracic trauma 5- hemodynamic changes 6- unable to supine position
Intervention groups
this is a diagnostic study,Diagnostic value of ultrasound to Locate the endotracheal tube In patients requiring intubation Compared to the gold standard (capnography).that done in patients who need intubation in emergency department and meet the inclusion criteria
Main outcome variables
More precise diagnosis of endotracheal tube placement
General information
Reason for update
Acronym
RSI
IRCT registration information
IRCT registration number:IRCT20161004030149N2
Registration date:2019-12-23, 1398/10/02
Registration timing:prospective
Last update:2019-12-23, 1398/10/02
Update count:0
Registration date
2019-12-23, 1398/10/02
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 317726332
Email address
smajidinejad@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-21, 1398/11/01
Expected recruitment end date
2020-09-21, 1399/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of the accuracy value of color Doppler epigastric ultrasound and superficial probe Suprasternal Natch sonography in comparison with standard capnography method in diagnose of tracheal tube location after intubation
Public title
sonography in tracheal tube location
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Emergency hospitalization
Requires intubation by RSI method
Absence of abdominal and thoracic trauma
Exclusion criteria:
occurrence of hemodynamic changes
unable to supine position
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
104
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the patient, which is intubated in the emergency room, location of tracheal tube determined by the emergency medicine assistant immediately with ultrasound device, and the emergency nurse simultaneously determines the accuracy of the endotracheal tube with capnography so that the two results do not match each other. They are informed and the information is given to the analyzer
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committee of isfahan university of medical science
Street address
isfahan university of medical science-hezar jerib blvd-isfahan
City
isfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Approval date
2019-09-29, 1398/07/07
Ethics committee reference number
IR.MUI.MED.REC.1398.246
Health conditions studied
1
Description of health condition studied
intubated patient
ICD-10 code
ICD-10 code description
d
Primary outcomes
1
Description
more precise diagnosis of endotracheal tube placementwith
Timepoint
Immediately after endotracheal intubation
Method of measurement
Compare to the gold standard that is capnography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
alzahra hospital
Full name of responsible person
saeed majidinejad
Street address
Emergency Department - Alzahra Hospital- Sofeh Ave - Isfahan
City
isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2085
Email
alzahra@mui.ac.ir
Web page address
http://alzahra.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
shaghayegh haghjooy javanmard
Street address
Hezar Jarib Street, Isfahan University of Medical Sciences, Staff Building No. 5 - Vice chancellor for research
City
isfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Phone
+98 31 3668 8138
Email
research@mui.ac.ir
Web page address
https://research.mui.ac.ir/fa/contact
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?