Comparison of the success rate of semi-sitting position compared with the supine position in emergency intubation
Design
Controlled clinical trial, Non blinded, Randomized
Settings and conduct
In this study, 54 patients in each intervention groups and control group, a total of 162 patients candidate for emergency tracheal intubation at Isfahan Alzahra hospital enter in the study. The intervention is tracheal intubation in semi-setting positions at 25 ° and 35 ° angle. Then, the number of examinations for tracheal intubation, the Cormack-Lehane scale, heart rate, systolic and diastolic blood pressure compare between the three groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patient consent for participant; Exclusion criteria: Need to surgery for tracheal intubation
Intervention groups
Intervention groups include patients candidate for emergency tracheal intubation that are located in semi-setting position at 25 degree or 35 degrees angle. The control group consists of patients who are candidate for emergency tracheal intubation that are located in the supine position.
Main outcome variables
Number of examinations for tracheal intubation; Carmack-Lehane scale; Heart rate; Systolic blood pressure; Diastolic blood pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181203041838N1
Registration date:2019-07-23, 1398/05/01
Registration timing:retrospective
Last update:2019-07-23, 1398/05/01
Update count:0
Registration date
2019-07-23, 1398/05/01
Registrant information
Name
Mohammad Nasr-Esfahani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3620 2085
Email address
m_nasr@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-20, 1396/12/01
Expected recruitment end date
2019-02-20, 1397/12/01
Actual recruitment start date
2018-03-03, 1396/12/12
Actual recruitment end date
2019-03-03, 1397/12/12
Trial completion date
2019-03-03, 1397/12/12
Scientific title
Comparison of the success rate of semi-sitting position in comparison with the resting position in emergency intubation
Public title
Comparison of the success rate of semi-sitting position in comparison with the resting position in emergency intubation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent of patient
Exclusion criteria:
Need to surgery for intubation
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
162
Actual sample size reached:
162
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezarjarib Street
City
اصفهان
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Approval date
2018-01-31, 1396/11/11
Ethics committee reference number
RI.MUI.REC.1396.3.864
Health conditions studied
1
Description of health condition studied
Emergency intubation
ICD-10 code
T88.4
ICD-10 code description
Failed or difficult intubation
Primary outcomes
1
Description
Number of examinations for tracheal intubation
Timepoint
After intervention
Method of measurement
Direct observation
2
Description
Cormack-Lehane score
Timepoint
During intervention
Method of measurement
Direct observation
3
Description
Heart rate
Timepoint
During intervention
Method of measurement
Pulse meter
4
Description
Sistolic blood pressure
Timepoint
During intervention
Method of measurement
Blood pressure monitor
5
Description
Diastolic blood pressure
Timepoint
During intervention
Method of measurement
Blood pressure monitor
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Tracheal intubation in semi-setting position at 25-degree angle
Category
Treatment - Other
2
Description
Intervention group: Tracheal intubation in semi-setting position at 35-degree angle
Category
Treatment - Other
3
Description
Control group: Tracheal intubation in supine position
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Alzahra hospital
Full name of responsible person
Amir Reza Hoshmand
Street address
Alzahra hospital, Sofeh Blvd
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
alzahra@mui.ac.ir
Web page address
http://alzahra.mui.ac.ir/undefined
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
شقایق حق جوی جوانمرد
Street address
Isfahan University of Medical Sciences, Hezarjarib street
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Phone
+98 31 3668 0048
Email
research@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
Amir Reza Hoshmand
Position
Resident of emergency medicine
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Isfahan University of medical Sciences, Hzarjarib Street
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Phone
+98 31 3668 8138
Email
amir.hm88@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Hossein Nasr Isfahani
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Isfahan University of Mdical Sciences, Hezarjarib street
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Phone
+98 31 3668 8138
Email
amir.hm88@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Amir Reza Hoshmand
Position
Resident of emergency medicene
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Isfahan University of Medical Sciences, Hezarjarib street
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Phone
+98 31 3668 8138
Email
amir.hm88@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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