Comparison of the view of the larynx, the time spent for intubation and the success rate of tracheal intubation with a gladoscope and Sanyar video laryngoscope in adults patients with difficult airway during induction of anesthesia
Determining the time required for tracheal intubation and with Sanyar video laryngoscope success rate of intubation among patients with difficult airway
Design
A single-blind randomized clinical trial with control group, and parallel groups, on 70 patients. Computer-generated random table method was used for randomization
Settings and conduct
A single-blind clinical trial study is performed on patients with difficult airway who candidate for surgery , and need laryngoscopy and tracheal intubation at Sina Hospita
Blinding is the person who collects the data and the analyst.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All patients who are candidates for surgery; Ages 18-70 who need tracheal intubation and have difficult airway criteria. Non-inclusion criteria: Patients with a history of an easy documented tracheal intubation (first attempt success); history of unsuccessful intubation and failed ventilation mask; known unstable cervical spine injury; age less than 18 years; or patients who have an emergency surgery
Intervention groups
Intervention group: Patients who are candidates for surgery and need tracheal intubation in the operating room, after monitoring and injecting anesthetic drugs, laryngoscopy is performed with a Sanyar video laryngoscope. Control group: Laryngoscopy is performed with GlideScope laryngoscopy.
Main outcome variables
View of the larynx, duration of intubation, success rate of intubation in the first attempt, during laryngoscopy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130304012695N15
Registration date:2023-01-25, 1401/11/05
Registration timing:prospective
Last update:2023-01-25, 1401/11/05
Update count:0
Registration date
2023-01-25, 1401/11/05
Registrant information
Name
mohammadreza khajavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6312 1220
Email address
khajavim@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-04, 1402/01/15
Expected recruitment end date
2024-06-19, 1403/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the view of the larynx, the time spent for intubation and the success rate of tracheal intubation with a gladoscope and Sanyar video laryngoscope in adults patients with difficult airway during induction of anesthesia
Public title
Evaluation of the speed and accuracy of laryngoscopy with the Sanyar video laryngoscope in patients with airway problems
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 18-70 years old
Candidates for elective surgeries need tracheal intubation
Having difficult airway criteria
Exclusion criteria:
Patients with a history of easy documented tracheal intubation
History of failed intubation and failed ventilation mask
Known unstable cervical spine injury
Patients having an emergency surgery.
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
For the randomization of patients who meet the inclusion criteria, the method of four blocks including intervention and control groups will be used.The preparation of randomization sequences will be done using the Random Generator software and the created sequences will be given to a trained staff member of the operating room who is not a member of the research group.The researchers of this study will not be aware of the existing sequences and arrangement of the blocks.After the patient enters the operating room, the trained person removes the first sequence from the special box of this study and according to the predetermined protocol, if it is S, it will be transferred to the intervention group, and if it is G, it will be transferred to the control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients participating in the study are not aware of the type of laryngoscope for intubation. The name of the person collecting the research information is not on the list of researchers.
The analyzer is not involved in the research process.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the School of Medicine, Tehran University of Medical Sciences
Street address
Sina hospital, Hasan Abad Sq., Emam Khomeni st.
City
Tehran
Province
Tehran
Postal code
1136746911
Approval date
2023-01-24, 1401/11/04
Ethics committee reference number
IR.TUMS.SINAHOSPITAL.REC.1401.099
Health conditions studied
1
Description of health condition studied
intra tracheal intubation
ICD-10 code
T88.4XXA
ICD-10 code description
Failed or difficult intubation, initial encounter
Primary outcomes
1
Description
Glotic view
Timepoint
At the time of laryngoscopy
Method of measurement
According to Cormac criteria
2
Description
Duration of intubation
Timepoint
From the moment the laryngoscope enters the mouth to observe the expiratory wave of the capnograph
Method of measurement
With stopwatch and in seconds
3
Description
Successes rate in first try
Timepoint
During laryngoscopy and intubation
Method of measurement
Divide the number of successful intubation attempts by the total number of attempts
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intubation is done with a Sanyar video laryngoscope
Category
Treatment - Devices
2
Description
Control group: Tracheal Intubation is performed by direct laryngoscopy
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Mohammad Reza khajavi
Street address
Sina Hospital Hassan Abad sq, Emmam Khomini st.
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8555
Fax
+98 21 6634 8551
Email
khajavim@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotouhi
Street address
Central building of Tehran University of Medical sciences, Ghods st., Keshavarz blv.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Reza Khajavi
Position
Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Imam khomeni St, Hasan Abad Sq, Sina hospital
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6312 0000
Fax
+98 21 6634 8553
Email
khajavim@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Reza Khajavi
Position
Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Imam khomeni St, Hasan Abad Sq, Sina hospital
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6312 0000
Fax
+98 21 6634 8553
Email
khajavim@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Reza Khajavi
Position
Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Imam khomeni St, Hasan Abad Sq, Sina hospital
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6312 0000
Fax
+98 21 6634 8553
Email
khajavim@tums.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
Main study outcome data
When the data will become available and for how long
Six months after the end of the study
To whom data/document is available
University and industry researchers
Under which criteria data/document could be used
Share experiences to increase the use of video laryngoscope
From where data/document is obtainable
khajavim@tums.ac.ir Dr.khajavi
What processes are involved for a request to access data/document
Through Dr. Khajavi e-mail address: khajavim@tums.ac.ir