Protocol summary

Study aim
The aim of the study is to compare simple laryngoscopy versus stylet with a camera in terms of time and number of times required for intubation of patients requiring general anesthesia in the operating room of Sina Hospital.
Design
A clinical trial with a control group, with a parallel group, three blind strains, randomized, phase 3 on 90 patients, random block method was used to randomly assign people.
Settings and conduct
In this plan, patients in need of general anesthesia are randomly divided into two groups, one group is intubated by simple laryngoscopy and the other group is intubated by laryngoscopy and intubation with a camera stylet. The camera stylet includes a camera with a maximum diameter of 5.5 mm, at the tip of a rigid and flexible wire or a flexible metal rod. Entered patients and data analyzers do not know in which group they are placed.
Participants/Inclusion and exclusion criteria
The inclusion criteria of patients includes all patients who have been under general anesthesia and need a tracheal tube number 7 and above. Exclusion criteria include patients who need an endotracheal tube smaller than 7, and also patients who need awake intubation due to their clinical status and history of previous diseases, cannot be included in this study.
Intervention groups
Patients who were randomly included in the study and in addition to simple laryngoscopy are intubated with a Macintosh laryngoscope by a stylet with a camera that is placed inside the tracheal tube.
Main outcome variables
The success rate of the first intubation attempt; overall success rate; view of the larynx; Intubation time

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191023045213N2
Registration date: 2024-07-11, 1403/04/21
Registration timing: prospective

Last update: 2024-07-11, 1403/04/21
Update count: 0
Registration date
2024-07-11, 1403/04/21
Registrant information
Name
Amir Sadrinia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4472 1657
Email address
sadriamir73@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-22, 1403/06/01
Expected recruitment end date
2025-01-19, 1403/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of simple laryngoscopy with and without camera stylet for intubation
Public title
Laryngoscopy and intubation with camera stylet
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
All patients who have been under general anesthesia and need a tracheal tube number 7 and above.
Exclusion criteria:
Patients who require tracheal tubes smaller than number 7. Patients who need awake intubation due to their clinical condition and history of previous diseases.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 180
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, random block method is used for random allocation of people. In order to be able to compare people and maintain balance, the samples are divided into two equal groups by block randomization method. In this method, the size of the blocks is used randomly (blocks 2, 4, 8) with an equal number of each group in each block. For example, in the block of 4 people, 2 treatments and 2 controls are placed. or in the block of 8, 4 treatments and 4 controls are placed. To avoid revealing the last allocation in each block, the blocks themselves are also randomly selected. For example, the selected block is 4, for each person in the study, one sheet is removed from the block of 4, which is randomly assigned to one of the intervention or control groups, and this process continues until the sheets are finished. Again, the block of 4 is returned to the table drawer, and to determine the group of other people, a block is randomly selected again, which may be 8 or 4, etc., and this process continues until the sample size is exhausted.
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
Research Ethics Committee of Sina Hospital - Tehran University of Medical Sciences
Street address
Building 6, Sina Hospital, Imam Khomeini Ave
City
Tehran
Province
Tehran
Postal code
1136746911
Approval date
2023-06-27, 1402/04/06
Ethics committee reference number
IR.TUMS.SINAHOSPITAL.REC.1402.043

Health conditions studied

1

Description of health condition studied
Simple laryngoscopy versus camera stylet
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Successful intubation
Timepoint
Immediately after intubation
Method of measurement
Observation of capnograph or bilateral auscultation of the lungs

2

Description
intubation time
Timepoint
Time from start of laryngoscopy to observation of capnograph
Method of measurement
Stopwatch

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients are entered randomly and in addition to simple laryngoscopy, they are intubated with a Macintosh laryngoscope by a stylet with a camera that is placed inside the tracheal tube and the time of intubation until the endotracheal tube is connected to capnography and EtCO2 is observed and the number of times that intubation is performed is measured. The stylet with a camera includes a camera with a diameter of up to 5.5 mm, around which small LEDs are installed to illuminate the path, and at the tip of a hard and flexible wire or a flexible metal rod with a diameter of up to 5 .5 mm is placed. The installed camera is connected to the laryngoscopy person's mobile phone via Wi-Fi. Tracheal tube number 7 and above is mounted on a rod to be placed inside the trachea, and after raising the tongue with a simple laryngoscope or any other tool that can hold the patient's tongue up, it is possible to see the bottom of the pharynx and find the epiglottis and trachea, and simultaneously insert the tube.
Category
Treatment - Devices

2

Description
Control group: Patients are intubated according to the standard intubation method after receiving induction or sedation under direct laryngoscopy.The time of intubation is measured until the endotracheal tube is connected to capnography and EtCO2 is observed, and the number of times that intubation is performed is measured.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Dr Pezhman Purfakhr
Street address
Imam khomeini Ave
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 912 200 8857
Email
POURFAKHR@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Farhad E'tezadi
Street address
Enghelab Ave
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3102
Email
stat@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
10
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
Dr Pezhman Purfakhr
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Imam khomeini Ave
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8500
Email
POURFAKHR@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Mohamadreza Neyshabury
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Imam khomeini Ave
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8500
Email
sadriamir73@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Amir Sadrinia
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Imam khomeini Ave
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8500
Email
sadriamir73@gmail.com

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
Yes - There is 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
After the final analysis, the information is published in the form of graphs and tables.
When the data will become available and for how long
The access period starts one year after the results are published.
To whom data/document is available
محققین شاغل در موسسات دانشگاهی و علمی
Under which criteria data/document could be used
In order to obtain additional information to use the studied method
From where data/document is obtainable
Tehran university of medical science
What processes are involved for a request to access data/document
Send the request to the project manager's email (Amir Sadrinia) Then receiving information from Tehran University of Medical Sciences The maximum time required is 2 working days
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