The success rate of intubation is compared using bougie and stylet guide in patients under general anesthesia.
If the results of the study show the superiority of one method over the other (ease of intubation and absence of complications), that method can be used in cases of hard intubation.
Design
Clinical trial with two intervention groups, parallel groups, double blind, randomized with https://www.sealedenvelope.com/ site, without phase, each group consisting of 67 people
Settings and conduct
Patients are randomly assigned into two equal groups with block randomization. Intubation in the first group is done by the tracheal tube and the stylet guide inside it, and in the second group, we transfer the tracheal tube into the trachea with the guide of a bougie. In each of the two methods, the required time for successful intubation in each patient will be recorded by a stopwatch.
The patients and the investigator responsible for collecting the dat are blinded to the randomization.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
ASA Class 1 and 2
Between 18 and 65 years old
Mallampati Class 3 and 4
Mandibular protrusion test class B & C
Patient satisfaction
Absence Pregnancy
No history of cardiovascular disease
Absence of coagulation disorders
Nondrug use
Exclusion criteria:
Insufficient or no ventilation during induction
Unsuccessful intubation
Intervention groups
The first intervention group: Intubation is performed using a tracheal tube with a stylet guide at an angle of 25 to 35 degrees.
The second intervention group: intubation is performed using a bougie. First, we will place a bogie into the larynx with a laryngoscope, and then we will move the tracheal tube into the trachea on the bougie.
Main outcome variables
Comparison of the required time for successful intubation and the rate of ease of endotracheal intubation in each group
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230508058115N1
Registration date:2023-08-19, 1402/05/28
Registration timing:registered_while_recruiting
Last update:2023-08-19, 1402/05/28
Update count:0
Registration date
2023-08-19, 1402/05/28
Registrant information
Name
Elham Sedghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3526
Email address
esedghi98@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-05, 1401/12/14
Expected recruitment end date
2024-03-18, 1402/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the success rate of intubation using bougie and stylet in patients under general anesthesia
Public title
Comparison of the success rate of intubation using bougie and stylet
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
ASA class 1 & 2
Age between 18- 65 years
Mallampati class 3 & 4
Mandibular protrusion test Class B & C
Patient satisfaction
Not pregnant
No history of cardiovascular disease (Cardiac arrhythmia, ischemia, heart block)
Absence of coagulopathy
No substance abuse
Exclusion criteria:
Insufficient or no ventilation during induction
failed intubation (if intubation is not done after three attempts, intubation is done using a glide scope or LMA and they are excluded from the study.)
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
134
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly divided into two equal groups with block randomization in blocks of 4.
Random sequences are performed using the online application on the https://www.sealedenvelope.com/ site. Random chain hiding is done using matte envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and the investigator responsible for collecting data are blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Arak University of Medical Sciences
Street address
Faculty of medicine, Arak University of Medical Sciences, Great Prophet University Complex, Basij Square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2023-03-05, 1401/12/14
Ethics committee reference number
IR.ARAKMU.REC.1401.344
Health conditions studied
1
Description of health condition studied
Intubation with stylet
ICD-10 code
T88.4
ICD-10 code description
Failed or difficult intubation
2
Description of health condition studied
Intubation with bougie
ICD-10 code
T88.4
ICD-10 code description
Failed or difficult intubation
Primary outcomes
1
Description
The time required for successful intubation with a stylet guide
Timepoint
Measuring the time required for successful intubation of a patient under general anesthesia
Method of measurement
Stopwatch
2
Description
The time required for successful intubation with a bougie
Timepoint
Measuring the time required for successful intubation of a patient under general anesthesia
Method of measurement
Stopwatch
Secondary outcomes
1
Description
Determining the ease of intubation with a stylet guide
Timepoint
Determining the ease of intubation while doing it
Method of measurement
Easy intubation means successful intubation on the first attempt in less than 15 seconds, relatively difficult intubation means successful intubation in 15-30 seconds, and difficult intubation means successful intubation with more than one attempt. (Successful intubation on the second attempt) and failure to perform intubation is called inability to intubate using any of the studied methods.
2
Description
Determining the ease of intubation with a bougie
Timepoint
Determining the ease of intubation while doing it
Method of measurement
Easy intubation means successful intubation on the first attempt in less than 15 seconds, relatively difficult intubation means successful intubation in 15-30 seconds, and difficult intubation means successful intubation with more than one attempt. (Successful intubation on the second attempt) and failure to perform intubation is called inability to intubate using any of the studied methods.
Intervention groups
1
Description
first Intervention group: intubation using a tracheal tube with a stylet guide and recording the time and the number of attempts required for successful intubation.
Category
Treatment - Devices
2
Description
second Intervention group: intubation using a tracheal tube and a bougie and recording the time and the number of attempts required for successful intubation.