Comparative study of complications during and after intubation in patients undergoing surgery by direct and video laryngoscopy in Fatemi hospital in 1397 and 1398
Determine the complications during and after intubation in patients undergoing surgery by direct and video laryngoscopy in Fatemi hospital in 1397 and 1398
Design
Two arm parallel group randomised trial with blinded intra operative and post operative complications of Classic intubation and Video Laryngoscope Intubation
Settings and conduct
In this study, patients were devided into two groups of Classic Intubation and Video Laryngoscopy Intubation. Before dividing, for the first year residents of the anesthesiology, theoretical and practical classes on the mannequin are formed by the laryngoscope in the skill lab. Then by the anesthesiologist done direct laryngoscopy by three patients(Classic) and done video laryngoscopy by three patients. After completing the training and obtaining the minimum necessary skills for larangoscopy, the residents are under the supervison of a senior resident or anesthesiologist intubation by General anesthesia in the same induction. For residents of each group, the number of succesful intubations and the time of each intubation was recorded. If the time lasts more than 25 seconds or with the aproval of the senior resident or anesthesiologist the tube is not in the trachea failure is recorded.
Participants/Inclusion and exclusion criteria
Patients aged 18 to 70 years old with ASA 1 or 2 which conditions are General Anesthesia by Intubation ; Emergency patients with anatomical disorders of the face or cardio pulmonary disease
Intervention groups
In this study, patients were randomly selected according to the criteria for entering the study and randomly divided to two groups of Classic Intubation and Video Laryngoscope Intubation
Main outcome variables
Hemodynamic status
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190614043888N1
Registration date:2019-11-08, 1398/08/17
Registration timing:prospective
Last update:2019-11-08, 1398/08/17
Update count:0
Registration date
2019-11-08, 1398/08/17
Registrant information
Name
Pedram Golestaneh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3662 8970
Email address
g.golestaneh@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-06, 1398/09/15
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of complications during and after intubation in patients undergoing surgery by direct and video laryngoscopy in Fatemi hospital in 1397 and 1398
Public title
Comparative study of complications during and after intubation in patients undergoing surgery by direct and video laryngoscopy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The patient with condition of General Anesthesia by Intubation
Patient satisfaction for participate in the study
The patient ASA is 1 and 2
Candidate for Elective Surgery
Age of patients between 18 till 70 years old
Exclusion criteria:
Change in Intubation for example Rapid Sequence Intubation
Emergent patient
Anatomical disorders of mouth or tounge or face
The patient has a Cardio pulmonary disease
The patient has a Cold
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
132
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, people will be divided into two groups by random number table. According to this table, people in the couple's home will fall into the videolaryngoscope group and those in the individual home will be in the laryngoscopic group.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients entered the study after obtaining satisfaction without the methodological knowledge of Intubation, divided into two groups of Classic Intubation and Video Laryngoscope Intubation
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Ardabil University of Medical Sciences
Street address
Daneshghah Ave, Ardabil University of Medical Sciences
City
Ardabil
Province
Ardabil
Postal code
5618985991
Approval date
2018-05-05, 1397/02/15
Ethics committee reference number
IR.ARUMS.REC.1398.041
Health conditions studied
1
Description of health condition studied
In the study of Lyon et al., A randomized study between two groups of Direct laryngoscope and Video laryngoscope in emergent patients was done.Two groups of trained students, one group of Video laryngoscope and the others of Direct laryngoscope used.85 patients who needed emergency intubation were included in the study. Finally, in terms of the duration of intubation, the mean intake in Direct laryngoscopy who had the mean time 25.9 second and the other group was 30.4 second. Regarding the shorter time in Direct layngoscopy, but no statistically significant difference.(P value>0.05) Regarding the success rate of intubation in the above two methods, the success rate of intubation was in the Video laryngoscope 94.7% and in the Direct laryngoscope 86.1% but that was not statistically significant.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Duration of Intubation and its success rate
Timepoint
Intra intubation
Method of measurement
Stopwatch, Seeing
Secondary outcomes
1
Description
Hemodynamic status
Timepoint
Intra Intubation and 4 and 12 hours after operation
Method of measurement
Barometer, Questionnaire
Intervention groups
1
Description
Intervention group: Patients who need surgery under video Laryngoscopy are intubated. Laryngoscope for first year anesthesia assistants Theorical and practical classes in the classroom and training on mannequins in skill lab. After the training is over, Students are divided into two groups randomly assigned to Video laryngoscope intubation by general anesthesia under the supervision of their assistant.
Category
Prevention
2
Description
Control group: Patients who need surgery under Direct Laryngoscopy are intubated. After the training is over, Students are divided into two groups randomly assigned to Direct laryngoscope intubation by general anesthesia under the supervision of their assistant.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
ّFatemi Hospital
Full name of responsible person
Pedram Golestaneh
Street address
No. 20, Omid Alley (17th Alley), Valli St.
City
Ardabil
Province
Ardabil
Postal code
56196-43941
Phone
+98 31 3662 8970
Email
g.golestaneh@arums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Mohsen Sagha
Street address
Student Research Committee, Ardabil University of Medical Sciences, University St., Ardabil
City
Ardabil
Province
Ardabil
Postal code
۵۶۱۸۹-۵۳۱۴۱
Phone
+98 45 3351 3419
Fax
+98 45 3351 3419
Email
src@arums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil 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
Ardabil University of Medical Sciences
Full name of responsible person
Pedram Golestaneh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
No20, Omid Alley., Valli St.
City
Ardabil
Province
Ardabil
Postal code
56196-43941
Phone
+98 913 027 2048
Email
g.golestaneh@arums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Ali Mohammadian Ardi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Fatemi hospital, Shariati Ave.
City
Ardabil
Province
Ardabil
Postal code
56147-33775
Phone
+98 45 3326 1600
Email
mohammadian.a.e@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Pedram Golestaneh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
No. 20, Omid Alley., Vally St.
City
Ardabil
Province
Ardabil
Postal code
56196-43941
Phone
+98 913 027 2048
Email
g.golestaneh@arums.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
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Information on how the study is performed and the results of the study are shared
When the data will become available and for how long
Start of access period 12 months after the results are published
To whom data/document is available
All students and researchers working in academic institutes and universuties
Under which criteria data/document could be used
Using of the method and results of the study
From where data/document is obtainable
Student Research Committee of Ardabil University of Medical Sciences
What processes are involved for a request to access data/document
With a visit of Ardabil University of Medical Science, Refer to the Student Research Committee, then the student research projects registration system is accessible