The real aim of this study is Comparison of the rate of complication and successful orotracheal intubation performed with a stylet or without a stylet( for probability of stylet deletion in Endotracheal Intubation)
Design
Randomized Clinical Trial, Single blinded with parallel group
Settings and conduct
Endotracheal Intubation with direct Laryingoscopy in Emergency Department
Participants/Inclusion and exclusion criteria
Inclusion criteria;
All patient beyond 18 years old who need endotracheal intubation for medical reason for example: cardiopulmonary arrest, LOC, seltic shoke, seizure, COPD, Asthma, cardiac failure, pneumonia. Traumatic Brain Injeury
Exclusion criteria;
1. under 18 years old 2.history of cervical spine surgery 3.history of upper airway structural problems, laryngeal mass, 4.pregnant women
Intervention groups
one group intubated with stylet and another group intubated without use of stylet
Main outcome variables
Success rate of Intubation
Complication of intubation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191210045684N1
Registration date:2020-01-26, 1398/11/06
Registration timing:registered_while_recruiting
Last update:2020-01-26, 1398/11/06
Update count:0
Registration date
2020-01-26, 1398/11/06
Registrant information
Name
Adel Shokouhi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3231 0352
Email address
adelshokouhi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-23, 1398/06/01
Expected recruitment end date
2020-05-19, 1399/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare the rate of complication and successful orotracheal intubation performed with a stylet or without a stylet
Public title
Compare the rate of complication and successful orotracheal intubation performed with a stylet or without a stylet
History of cervical spine surgery
History of upper airway structural problems, laryngeal mass
Pregnant women
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
190
Randomization (investigator's opinion)
Randomized
Randomization description
Before biginnig of study, Patients devided into two groups by randome numbers table; first group intubated with stylet and second group intubated without use of stylet.
Blinding (investigator's opinion)
Single blinded
Blinding description
The patient has not any awareness oo intubation method
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe of Mazandaran University of Medical Sciences
Street address
Jouybar threeway-Vali Asre avenue
City
Sari
Province
Mazandaran
Postal code
48157-33971
Approval date
2019-08-19, 1398/05/28
Ethics committee reference number
IR.MAZUMS.IMAMHOSPITAL.REC.1398.072
Health conditions studied
1
Description of health condition studied
Endotracheal Intubation
ICD-10 code
T88.4
ICD-10 code description
Failed or difficult intubation
Primary outcomes
1
Description
Succession in Endotracheal Intubation
Timepoint
In the biginnig and immediately after procedure
Method of measurement
Check list
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Endo tracheal Intubation with Stylet that used traditionally for ease of intubation and may be with some complication.
Category
Treatment - Devices
2
Description
Control group: Endo tracheal Intubation without Stylet use for prevention of potentially complication
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam KHomeini Hospital
Full name of responsible person
Dr. Misagh Shafizad
Street address
Razi avenue
City
Sari
Province
Mazandaran
Postal code
48166-33131
Phone
+98 11 3336 1700
Email
ict@mazums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Majid Saeedi
Street address
Jouybar threeway, Valiasre avenue
City
Sari
Province
Mazandaran
Postal code
48157-33971
Phone
+98 11 3336 2569
Email
ict@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sari 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
Mazandaran University of Medical Sciences
Full name of responsible person
Adel Shokouhi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Razi avenue
City
Sari
Province
Mazandaran
Postal code
48166-33131
Phone
0098 11 33361700-4
Email
adelshokouhi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Adel Shokouhi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Razi avenue
City
Sari
Province
Mazandaran
Postal code
48166-33131
Phone
0098 11 33361700-4
Email
adelshokouhi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Adel Shokouhi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Razi avenue
City
Sari
Province
Mazandaran
Postal code
48166-33131
Phone
0098 11 33361700-4
Email
adelshokouhi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Endotracheal Intubation
When the data will become available and for how long
One month after print of rsaults
To whom data/document is available
All of Researchers
Under which criteria data/document could be used
without limitation
From where data/document is obtainable
Sari Imam KHomeini hospital
What processes are involved for a request to access data/document