Determining and comparing the success rate of intubation using SANYAR video laryngoscope and GlideScope in patients who are candidates for bariatric surgery.
Design
A clinical trial with a control group, with parallel groups, randomized using block randomization, phase 2-3 in 150 patients. www.sealedenvelope.com is used for randomization.
Settings and conduct
This randomized clinical trial study will be conducted on 150 patients undergoing bariatric surgery in three groups at Sina Hospital in Tehran. Random allocation of samples is done by block method. The variables and success status of intubation will be recorded by the research team during the operation and at the designated times.
Participants/Inclusion and exclusion criteria
Patients older than 18 years who were candidate for bariatric surgery will enroll to study, also patients with previous history of difficult intubation and history of cervical vertebra surgery were excluded from study.
Intervention groups
SANYAR group: patients who are candidates for Bariatric surgery, and SANYAR video Laryngoscope is used for their intubation.
GlideScope group: Patients who are candidates for Bariatric surgery, and GlideScope is used for their intubation.
Control group: Patients who are candidates for Bariatric surgery, and direct laryngoscopy with macintosh blade is used for their intubation.
Main outcome variables
Intubation success rate at first try
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220513054842N2
Registration date:2023-04-18, 1402/01/29
Registration timing:prospective
Last update:2023-04-18, 1402/01/29
Update count:0
Registration date
2023-04-18, 1402/01/29
Registrant information
Name
Mohamadreza Neishaboury
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4427 2306
Email address
mrneishaboury@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-05, 1402/02/15
Expected recruitment end date
2023-08-06, 1402/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating and comparing the success rate of intubation using SANYAR video laryngoscope and GlideScope in patients undergoing bariatric surgery
Public title
Investigating the success rate of intubation using SANYAR video laryngoscope and GlideScope
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients older than 18 years
Candidate for bariatric surgery
Exclusion criteria:
Previous history of difficult intubation
Previous history of cervical vertebra surgery
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
The block randomization method with block size of 6 will be used for the random allocation of patients. The website "www.sealedenvelope.com" will be used to create random blocks. It creates blocks randomly (keeping in mind that the number of study groups in each block is equal) and the total number of generated blocks will be 30. The randomization sequence then will be handed to a nurse anesthetist.
Blinding (investigator's opinion)
Single blinded
Blinding description
Following patients admission to operating room, patients' group or method for intubation (direct laryngoscopy, Glidescope, SANYAR) will be decided according to randomization sequences. The patients will not be notified about the allocation.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Sina Hospital, Tehran University of Medical Sciences
Street address
Sina Hospital, Imam Khomeini Street
City
Tehran
Province
Tehran
Postal code
1136746911
Approval date
2022-08-02, 1401/05/11
Ethics committee reference number
IR.TUMS.SINAHOSPITAL.REC.1400.126
Health conditions studied
1
Description of health condition studied
Bariatric surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Intubation success rate at first try
Timepoint
After intubation
Method of measurement
Based on observation
Secondary outcomes
1
Description
time of intubation
Timepoint
during intervention
Method of measurement
Time of intubation was defined as the duration from the laryngoscope blade enters the patient's mouth until the first capnography wave is observed on the monitor. This time will be recorded by a nurse anesthetist
Intervention groups
1
Description
SANYAR group: Patients who are candidates for Bariatric surgery and are going to be intubated with SANYAR videolaryngoscope.
Category
Treatment - Devices
2
Description
Glidescope group: Patients who are candidates for Bariatric surgery and are going to be intubated with GlideScope.
Category
Treatment - Devices
3
Description
Control group: Patients who are candidates for Bariatric surgery and are going to be intubated with direct laryngoscopy.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Dr. Mohammad Reza Neishaburi
Street address
Sina Hospital, Imam Khomeini St
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8550
Email
mrneneishabury@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fatuhi
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 3686
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
Mohamadreza Neishaboury
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Sinai Hospital, Imam Khomeini St
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8550
Fax
Email
mrneishaboury@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohamadreza Neishaboury
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Sinai Hospital, Imam Khomeini St
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8550
Fax
Email
mrneishaboury@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 Neishaboury
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Sinai Hospital,Imam Khomeini Street
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8550
Email
mrneishaboury@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
Yes - There is 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
Not applicable
Title and more details about the data/document
Main outcome data of the study
When the data will become available and for how long
6 months after completing the study
To whom data/document is available
University researchers
Under which criteria data/document could be used
Sharing scientific findings to increase the production of science
From where data/document is obtainable
Email address of Dr. Nishaboury: mrnishaboury@tums.ac.ir
What processes are involved for a request to access data/document
The request should be made by email and the answer will be given within two months