Comparison of the hemodynamic changes following tracheal intubation with direct laryngoscopy and fiberoptic bronchoscopy and glidescope in patients with ASA Class I-II elective surgery candidates
Comparison of hemodynamic changes following tracheal intubation by three direct laryngoscopy instruments, fibropetic bronchoscope, and glidescope
Design
Clinical intervention trial with parallel, blind, randomized groups
Settings and conduct
This study, which is a randomized clinical trial, is started by a random sampling of 195 patients in three groups. The choice of these individuals is randomized using a random number table and all patients selected are in the age group of 15 to 65 years old who are admitted to the surgical department of Baqiyatallah Hospital and have ASA class I and II. Patients and researchers are blinded, but the supervisor knows how each patient has been treated. Blindness is a two-way blind.
Participants/Inclusion and exclusion criteria
Patients with difficult intubation, obesity, systemic disease such as uncontrolled hypertension, heart disease, DM, uncontrolled hyperthyroidism, hypothyroidism and patients candidate for cesarean section
Intervention groups
Group 1: Patients whose intubations are performed by direct laryngoscopy
Group 2: Patients whose intubation was performed by a fibropetic bronchoscope
Group three: Patients whose intubation was done by a glidescope
Main outcome variables
Determination of reduction of hemodynamic changes after intubation by fibropetic bronchoscopy in comparison with direct laryngoscopy and glideoscope
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151031024799N4
Registration date:2019-05-05, 1398/02/15
Registration timing:registered_while_recruiting
Last update:2019-05-05, 1398/02/15
Update count:0
Registration date
2019-05-05, 1398/02/15
Registrant information
Name
Masoud Saghafinia
Name of organization / entity
Baqiyatallah university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8126 3207
Email address
dr_saghafi@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2019-05-22, 1398/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the hemodynamic changes following tracheal intubation with direct laryngoscopy and fiberoptic bronchoscopy and glidescope in patients with ASA Class I-II elective surgery candidates
Public title
Comparison of the hemodynamic changes following tracheal intubation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with ASA class I, II candidates for elective surgery
Exclusion criteria:
Patients with difficult intubation
obesity
uncontrolled hypertension
heart disease
DM
uncontrolled hyperthyroidism, hypothyroidism
patients candidate for cesarean section
Age
From 15 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:
196
Randomization (investigator's opinion)
Randomized
Randomization description
After entering the study and obtaining informed consent, patients will be randomly assigned to the random numbers table in three groups of 65.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient does not know which method of intubation receives; the researcher like the patient does not know which patient is in what group and which method he receives. The supervisor knows which patient gets what method.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of the Baqiyatallah University of Medical Sciences
Street address
Baqiyatallah University of Medical Sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1435915371
Approval date
2017-03-05, 1395/12/15
Ethics committee reference number
ir.BMSU.REC.1395.247
Health conditions studied
1
Description of health condition studied
Intubation
ICD-10 code
O29.6
ICD-10 code description
Failed or difficult intubation for anesthesia during pregnancy
Primary outcomes
1
Description
Blood pressure
Timepoint
Before and after induction and during intubation and one, three and five minutes after intubation
Method of measurement
Barometer cuff
2
Description
heart rate
Timepoint
Before and after induction and during intubation and one, three and five minutes after intubation
Method of measurement
Heart Rate Monitor
3
Description
Arterial oxygen saturation level
Timepoint
Before and after induction and during intubation and one, three and five minutes after intubation
Method of measurement
Pulse Oximeter
Secondary outcomes
1
Description
Incidence of myocardial infarction
Timepoint
At one year after surgery
Method of measurement
electrocardiogram
Intervention groups
1
Description
Intervention group1 : Patients whose intubation will be performed by a fiberopetic bronchoscope. Systolic and diastolic blood pressure and heart rate of patients are measured noninvasively, before and after induction, during intubation, and minutes after 1, 3, and 5 minutes after intubation.
Category
Treatment - Devices
2
Description
Intervention group: Patients whose intubation will be performed by a glidescope. Systolic and diastolic blood pressure and heart rate of patients are measured noninvasively, before and after induction, during intubation, and minutes after 1, 3, and 5 minutes after intubation.
Category
Treatment - Devices
3
Description
Control group: Patients whose intubation will be performed by a direct Laryngoscope . Systolic and diastolic blood pressure and heart rate of patients are measured noninvasively, before and after induction, during intubation, and minutes after 1, 3, and 5 minutes after intubation.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Baghiyyatollah al-Azam Hospital
Full name of responsible person
Masoud Saghafinia
Street address
Molla Sadra St, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8805 0435
Email
masoud.saghafinia1@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Dr Masoud Saghafinia
Street address
Molla Sadra St, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1435915372
Phone
+98 21 8805 0435
Email
masoud.saghafinia1@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah 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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Masoud Saghafinia
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Baghiyyatollah al-Azam Hospital, Molla Sadra St, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8805 0435
Email
masoud.saghafinia1@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Masoud Saghafinia
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Baghiyyatollah al-Azam Hospital, Molla Sadra St, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8805 0435
Email
masoud.saghafinia1@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Masoud Saghafinia
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Baghiyyatollah al-Azam Hospital, Molla Sadra St, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
14359115371
Phone
+98 21 8805 0435
Email
masoud.saghafinia1@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
The total data of the participants in the study after the unidentifiable individuals can be shared.
When the data will become available and for how long
The beginning of the access period is 6 months after the publication of the results.
To whom data/document is available
Data is only available to researchers working in scientific institutions.
Under which criteria data/document could be used
Authorized people can do all the analysesمت they need on the data.
From where data/document is obtainable
People can contact us by email:
masoud.saghafinia1@gmail.com
What processes are involved for a request to access data/document
Individuals can receive data within one day after emailing us.