Comparison of the glotic view and ease of endotracheal intubation with direct laryngoscopy and Wi-Fi video laryngoscope in adults patients during induction of anesthesia
Determining the time required for tracheal intubation and grading the laryngeal view with Wi-Fi video laryngoscope during induction of general anesthesia
Design
A single-blind randomized clinical trial with control group, and parallel groups, on 102 patients. Random generator software was used to randomize.
Settings and conduct
A single-blind clinical trial study is performed on patients undergoing general anesthesia that need laryngoscopy and tracheal intubation at Sina Hospital
Participants/Inclusion and exclusion criteria
Inclusion criteria: All patients undergoing surgery under general anesthesia, ages 18-80 years who need endotracheal intubation
Exclusion criteria:Patients who have an airway pathology Patients with a history of neck fixation surgery Patients with a body mass index greater than 40
Intervention groups
Intervention group: Patients who are candidates for general anesthesia and endotracheal intubation after monitoring and 4 minutes after injection of anesthetic drugs, laryngoscopy is performed with Wi-Fi video laryngoscope. Degree of laryngeal view, the time spent for intubation and the number of attempts, blood pressure and heart rate before and after laryngoscopy and the occurrence of sore throat after surgery are evaluated.
Control group: Laryngoscopy is performed with direct laryngoscopy with Macintosh blade and degree of laryngeal view, the time spent for intubation and the number of attempts, blood pressure and heart rate before and after laryngoscopy and the occurrence of sore throat after surgery are evaluated.
Main outcome variables
Duration of intubation, degree of larynx view, changes in blood pressure and heart rate during laryngoscopy, incidence of sore throat
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130304012695N8
Registration date:2020-11-27, 1399/09/07
Registration timing:registered_while_recruiting
Last update:2020-11-27, 1399/09/07
Update count:0
Registration date
2020-11-27, 1399/09/07
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
2020-10-21, 1399/07/30
Expected recruitment end date
2021-04-19, 1400/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the glotic view and ease of endotracheal intubation with direct laryngoscopy and Wi-Fi video laryngoscope in adults patients during induction of anesthesia
Public title
Evaluate the performance of WiFi laryngoscope video
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients who need an endotracheal intubation for general anesthesia
Exclusion criteria:
Patients who have an airway pathology
Patients with a history of neck fixation surgery
Patients with a body mass index greater than 40
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
102
Randomization (investigator's opinion)
Randomized
Randomization description
To randomize patients with inclusion criteria
Block balanced randomization is used.Before studying, one of the person who is not a member of the research team performs the randomization process by using Random generator software, forms blocks with size of 4 for the intervention and control group.
The complete cards of blocks are given to the head of the operating room, who is unaware of the study, in an envelope. A card is given to the patient after patient entrance to operating room.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients participating in the study are not aware of the type of laryngoscope for intubation
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of 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
2020-10-21, 1399/07/30
Ethics committee reference number
IR.TUMS.SINAHOSPITAL.REC.1399.060
Health conditions studied
1
Description of health condition studied
intra tracheal intubation
ICD-10 code
T88.4
ICD-10 code description
Failed or difficult intubation
Primary outcomes
1
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
Secondary outcomes
1
Description
blood pressure
Timepoint
before and after intubation
Method of measurement
Non invasive blood pressure/ mmhg
2
Description
Glotic view
Timepoint
At the time of laryngoscopy
Method of measurement
According to Cormac criteria
3
Description
Heart Rate
Timepoint
Before and after intubation
Method of measurement
with manitoring
4
Description
sore throate
Timepoint
After surgery
Method of measurement
Patient report of presence or absence
Intervention groups
1
Description
Intervention group: Intubation is done with a Wi-Fi 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
Email
khajavim@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
محمدعلی صحراییان
Street address
Keshavarz Blvd., Ghods St., Central Organization of the University, Sixth Department of Research and Technology
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
50
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Tehran University of Medical Sciences
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Sina Hospital Hassan Abad sq, Emmem Khomini st
City
Tehra
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8555
Email
khajavim@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Reza Khajavi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Sina Hospital ,Hassan abad sq, Emmam Khomine st
City
: Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8555
Email
khajavim@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Reza Khajavi
Position
Professor,
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Sina Hospital ,Hassan abad sq, Emmam Khomine st
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8555
Email
khajavim@tums.ac.ir
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
No - There is not 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
No - There is not a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The results of the main study data
When the data will become available and for how long
6 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
Dr. Khajavi e-mail address
khajavim@tums.ac.ir
What processes are involved for a request to access data/document