Comparison between two methods of emergency rapid sequence intubations (with and without apneic oxygenation) regarding arterial oxygen desaturation during tube placement
To elucidate the possible effect of apneic oxygenation on delaying the arterial oxygen desaturation during laryngoscopy for rapid sequence intubation in the emergency department
Design
Randomised, non-blinded, parallel group without concealment, including two groups with 30 patients in each group.
Settings and conduct
This study will be performed in Bahonar Academic Hospital, an urban level 2 trauma center located in Kerman, Iran. Rapid sequence intubation is performed by the most skilled patient available in the emergency department (senior resident of emergency medicine or the attending physician of emergency medicine), with the researcher observing the condition and documenting the data. Patients who are not assigned to the intervention are intubated using the standard protocol (pre-oxygenation, pre-treatment, induction, ....) and those who are assigned to apneic oxygenation receive oxygen in addition to the standard of care.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Trauma patients over 18 years of age needing emergency orotracheal intubation.
Exclusion criteria: Patients who are not candidates for rapid sequence intubation; Patients who remain hypoxic (arterial oxygen saturation<95%) despite adequate pre-oxygenation; Patients whose arterial oxygen saturation can not be traced using pulse oxymetry for any reason (like hemodynamic shock, etc.)
Intervention groups
Our intervention includes oxygenation via a nasal cannula with oxygen flow rate of 10 L/min during the apneic stage of rapid sequence intubation, during which laryngoscopy is performed and is followed by tube placement. The current standard of rapid sequence intubation does not include apneic oxygenation during laryngoscopy.
Main outcome variables
Arterial oxygen saturation immediately after the tube placement
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131226015941N6
Registration date:2018-07-27, 1397/05/05
Registration timing:registered_while_recruiting
Last update:2018-07-27, 1397/05/05
Update count:0
Registration date
2018-07-27, 1397/05/05
Registrant information
Name
Amirhossein Mirafzal
Name of organization / entity
Kerman University of Medical sceinces
Country
Iran (Islamic Republic of)
Phone
+98 34 1247 4638
Email address
mirafzal@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-11, 1397/04/20
Expected recruitment end date
2018-10-02, 1397/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between two methods of emergency rapid sequence intubations (with and without apneic oxygenation) regarding arterial oxygen desaturation during tube placement
Public title
Oxygenation via nasal cannula during laryngoscopy by the emergency physicians: A comparison between the users and the non-users
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Trauma patients over 18 years of age needing emergency orotracheal intubation in the emergency department
Exclusion criteria:
Patients who are not candidates of rapid sequence intubation (RSI) for any reason
Patients who remain hypoxic (arterial oxygen saturation<95%) despite adequate pre-oxygenation
Patients whose arterial oxygen saturation could not be traced using pulse oxymeter (for any reason like hemodynamic shock, etc.))
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
We use simple randomization using random numbers table. Each individual is a unit for randomization. The even numbers will be assigned to group 1 (no oxygenation during laryngoscopy) and the odd numbers will be assigned to group 2 (oxygenation via nasal cannula during laryngoscopy). There is no allocation cocealment in this study.
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 commitee of Afzalipoor Clinical Reseach Center, Kerman University of Medical Sciences
Street address
Imam Khomeini Rd., next to the Bahonar University, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913911
Approval date
2018-01-20, 1396/10/30
Ethics committee reference number
IR.KMU.AH.REC.1396.2092
Health conditions studied
1
Description of health condition studied
Endotracheal intubation
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Arterial oxygen saturation immediately after the endotracheal tube placement
Timepoint
Once, immediately after endotracheal tube placement
Method of measurement
Reading of pulse oxymetry
Secondary outcomes
1
Description
Time taken (in seconds) for each attempt (laryngoscopy) at intubation
Timepoint
Once at the end of each attempt
Method of measurement
Taking the time by the researcher
2
Description
Number of attempts at intubation
Timepoint
Once at the end of intubation
Method of measurement
Counting by the researcher
Intervention groups
1
Description
Control group: Standard rapid sequence intubation
Category
Treatment - Devices
2
Description
Intervention group: Standard rapid sequence intubation with added oxygenation during the apneic period (laryngoscopy)
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Bahonar Academic Hospital
Full name of responsible person
Amirhossein Mirafzal
Street address
Gharani St., Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
mirafzal@kmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhty
Street address
Soamye cross, Ebne Sina st., Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3226 3855
Email
abpardakhty@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Amirhossein Mirafzal
Position
Assistant professor
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Bahonar Academic Hospital, Gharani St., Kerman
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
mirafzal@kmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Amirhossein Mirafzal
Position
Assistant Professor
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Bahonar Academic Hospital, Gharani St., Kerman
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Fax
Email
mirafzal@kmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Amirhossein Mirafzal
Position
Assistant Professor
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Bahonar Academic Hospital, Gharani St.
City
Kerman
Province
Kerman
Postal code
7611747181
Phone
+98 34 3223 5011
Fax
Email
mirafzal@kmu.ac.ir
Web page address
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All collected deidentified IPD
When the data will become available and for how long
One month after publication
To whom data/document is available
Persons with Academic positions
Under which criteria data/document could be used
Data will be sent until one month after request for the qualified person(s).
From where data/document is obtainable
Request for data can be sent via email. (mirafzal@kmu.ac.ir- a.mirafzal@yahoo.com)
What processes are involved for a request to access data/document
Data will be sent via email until one month after request