Effect of using Covid۱۹ intubation box on success rate and time of tracheal intubation in patients undergoing surgery under general anesthesia
Design
This study is a double-blind clinical trial with parallel, randomized, phase 3 groups per 100 patients. Block randomization method is used for randomization
Settings and conduct
After obtaining informed consent, patients are randomly selected into two groups. In both groups, preoperative clinical examinations are performed. For patients, complete monitoring is performed and fluid therapy is performed, then anesthesia drugs are injected in both groups to initiate anesthesia and airway intubation is given as follows: midazolam 0.02 mg by weight, fentanyl 3 micrograms by weight , propofol 2 mg by weight and atracurium 0.5 mg by weight. Then airway intubation is performed in both groups and the time of entry of the endotracheal tube into the mouth to enter the glottis is recorded and measured. Success in intubation is also recorded in both groups. Covid box intubation consists of a simple transparent cubic chamber that has two inlets for the hands of the anesthesiologist to enter the airway intubation.This study is performed in Firoozgar Hospital in Tehran.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patient with ASA1,2 , Patient with Malampati scale1,2 Patients aged between 20 and 60 years
Intervention groups
Intervention group: patients candidate for surgery under general anesthesia with airway intubation using Covid۱۹ intubation box
Control group: patients candidate for surgery under general anesthesia with normal airway intubation
Main outcome variables
Airway intubation time, success rate of airway intubation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140109016151N10
Registration date:2021-11-27, 1400/09/06
Registration timing:prospective
Last update:2021-11-27, 1400/09/06
Update count:0
Registration date
2021-11-27, 1400/09/06
Registrant information
Name
Alireza Pournajafian
Name of organization / entity
Iran University of Medical Siences
Country
Iran (Islamic Republic of)
Phone
+98 21 8894 6762
Email address
a-pournajafian@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-21, 1400/09/30
Expected recruitment end date
2022-12-21, 1401/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of using Covid۱۹ intubation box on success rate and time of tracheal intubation in patients undergoing surgery under general anesthesia
Public title
Effect of using Covid۱۹ intubation box on success rate and time of tracheal intubation in patients undergoing surgery under general anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient with ASA 1 , 2
Patient with Malampati scale 1 , 2
Patients aged between 20 and 60 years
Exclusion criteria:
Failure to airway intubation after two attempts with Covid۱۹ intubation box
Defective airway intubation tools
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Care provider
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we use the block randomization method. to randomize the two treatment methods, we create 4 blocks in six different states, then select a number using the table of numbers, and determine the study groups by matching the numbers with the blocks.
For example, if the first digit of our number is 1 to 6, select a block and the division is done, but if, for example, our number is 94071, the digit 9 is not valid and we select the next digit.
Here, based on the block, we divide 4 people into groups.
1. TTCC 2. TCTC 3. TCCT
4. CCTT 5. CTCT 6. CTTC
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, people who are responsible for patient care and analysis of statistical data do not know about the treatment process and study groups, and information is provided to them in groups A and B
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Tehran, Hemmat Highway next to Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
8874113911
Approval date
2021-03-02, 1399/12/12
Ethics committee reference number
IR.IUMS.FMD.REC.1399.780
Health conditions studied
1
Description of health condition studied
General surgery
ICD-10 code
Y81.1
ICD-10 code description
Therapeutic (nonsurgical) and rehabilitative general- and plastic-surgery devices associated with adverse incidents
Primary outcomes
1
Description
Airway intubation time
Timepoint
Beginning of induction of anesthesia
Method of measurement
The watch
Secondary outcomes
1
Description
Success rate of airway intubation
Timepoint
Beginning of induction of anesthesia
Method of measurement
Observation
Intervention groups
1
Description
Intervention group: Intervention group: After obtaining informed consent, patients are randomly selected into two groups. In the first group, preoperative clinical examinations are performed. For patients, complete monitoring is performed and fluid therapy is performed, then anesthesia drugs to initiate anesthesia and airway intubation are injected as follows: midazolam 0.02 mg by weight, fentanyl 3 micrograms by weight, propofol 2 Mg by weight and atracurium 0.5 mg by weight.Then, for the patients in the intervention group, Covid 19 Box intubation consists of a clear, cubic-shaped clear acrylic chamber with two inlets for the anesthesiologist to insert into the airway. airway intubation is then performed and the time it takes for the endotracheal tube to enter the mouth to enter the glottis is recorded and measured. Success in airway intubation is also recorded.
Category
Treatment - Devices
2
Description
Control group: Control group: After obtaining informed consent, patients are randomly selected into two groups. In the control group, preoperative clinical examinations are performed. For patients, complete monitoring is performed and fluid therapy is performed, then anesthesia drugs to initiate anesthesia and airway intubation are injected as follows: midazolam 0.02 mg by weight, fentanyl 3 micrograms by weight, propofol 2 Mg by weight and atracurium 0.5 mg by weight. Then, for the patients in the control group, airway intubation is performed normally using a laryngoscope and Macintosh blade No. 4. Then airway intubation is performed and the time of endotracheal tube entry into the mouth to enter the glottis is recorded and measured. Be. Success rates for airway intubation are also recorded.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Firoozgar hospital
Full name of responsible person
Alireza Pournajafian
Street address
Anesthesia Department, Firouzgar Hospital ,Beh-afarin street
City
Tehran
Province
Tehran
Postal code
8874113911
Phone
+98 21 8894 6762
Email
a-pournajafian@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hosein Keyvani
Street address
Hemmat Highway next to Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
8874113911
Phone
+98 21 8670 5503
Email
research-m@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Alireza Pournajafian
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesia Department, Firouzgar Hospital ,Beh-afarin street
City
Tehran
Province
Tehran
Postal code
8874113911
Phone
+98 21 8894 6762
Email
a-pournajafian@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Alireza Pournajafian
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesia Department, Firouzgar Hospital ,Beh-afarin street
City
Tehran
Province
Tehran
Postal code
8874113911
Phone
+98 21 8894 6762
Email
a-pournajafian@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Alireza Pournajafian
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesia Department, Firouzgar Hospital ,Beh-afarin street
City
Tehran
Province
Tehran
Postal code
8874113911
Phone
+98 21 8894 6762
Email
a-pournajafian@tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available