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Comparative evaluation direct laryngoscopy versus Glidescope for the purpose of laryngoscopy management and intubation in candidates of caesarean delivery with general anesthesia

Protocol summary

Study aim
Determining and comparing the direct laryngoscopy versus Glidescope for the purpose of laryngoscopy management and intubation in candidates of caesarean delivery with general anesthesia
Design
A randomized, double-blinding clinical trial, with the parallel groups, Phase 2 on 90 patients
Settings and conduct
In this randomized double-blind clinical trial, 90 eligible patients referred to Beheshti Hospital in Isfahan will be included in the study and randomly divided into two groups. The first group will undergo direct intubation and the second group will be intubated by GlideScope video. Then, hemodynamic parameters of patients, laryngoscopy time, and the number of attempts for intubation between the two groups will be compared.
Participants/Inclusion and exclusion criteria
Inclusion criteria consisted of pregnant women that were candidates for cesarean section under general anesthesia, with the American Society of Anesthesiologists (ASA) score of one or two, the gravidity of one or two, and Intubation Difficulty Scale (IDS) score of equal or less than 5. exclusion criteria consisted of the thyromental distance (TMD) was less than 6 cm, the neck circumference (NC) was equal or more than 43 cm, patients with increased intracranial pressure, any airway pathology, cervical spinal cord injury, and requirement for rapid induction.
Intervention groups
The first intervention group: Patients in the first group underwent intubation using the direct Macintosh laryngoscope with Macintosh blade No. 3. The second intervention group: Patients in the second group underwent intubation using GlideScope video laryngoscope.
Main outcome variables
Hemodynamic parameters; Laryngoscopy time; Number of attempts for intubation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200825048515N44
Registration date: 2021-10-06, 1400/07/14
Registration timing: retrospective

Last update: 2021-10-06, 1400/07/14
Update count: 0
Registration date
2021-10-06, 1400/07/14
Registrant information
Name
Asieh Maghami Mehr
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 0000 0000
Email address
asimaghami@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-21, 1400/02/01
Expected recruitment end date
2021-08-22, 1400/05/31
Actual recruitment start date
2021-04-21, 1400/02/01
Actual recruitment end date
2021-08-22, 1400/05/31
Trial completion date
2021-08-22, 1400/05/31
Scientific title
Comparative evaluation direct laryngoscopy versus Glidescope for the purpose of laryngoscopy management and intubation in candidates of caesarean delivery with general anesthesia
Public title
Comparison of direct laryngoscopy versus Glidescope for the purpose of laryngoscopy management and intubation in candidates of caesarean delivery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women that were candidates for cesarean section under general anesthesia Class I and II classification of the American Society of Anesthesiologists The gravidity of one or two Intubation Difficulty Scale (IDS) score of equal or less than 5
Exclusion criteria:
The thyromental distance (TMD) was less than 6 cm The neck circumference (NC) was equal or more than 43 cm Patients with an increased intracranial pressure Any airway pathology Any cervical spinal cord injury requirement for rapid induction
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 90
Actual sample size reached: 90
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 90 eligible patients will be randomly selected. Then random numbers are created by computer software "Random Allocation". These numbers are randomly divided into two groups A (first intervention) and B (second intervention). Each number is written on paper and placed in an envelope. Then each patient is asked to choose an envelope from among the envelopes. According to the selected envelope, the patient will be assigned to one of the two groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
To meet the blinding condition in the study, the anesthesiologist that was responsible for performing intubation did not take part in the collection of patients’ information due to knowledge of the type of intervention in each of the two groups; however, the patient, the patient data collector, and the statistician were not aware of the type of intervention in two groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Street address Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq
City
Isfahan
Province
Isfehan
Postal code
8179964167
Approval date
2019-03-02, 1397/12/11
Ethics committee reference number
IR.MUI.MED.REC.1397.282

Health conditions studied

1

Description of health condition studied
Elective cesarean section
ICD-10 code
O82.0
ICD-10 code description
Delivery by elective caesarean section

Primary outcomes

1

Description
Number of attempts for intubatio
Timepoint
At the time of intubation
Method of measurement
Number of attempts

2

Description
Time-to-intubation
Timepoint
At the time of intubation
Method of measurement
from the time the laryngoscope was inserted into the mouth to the filling of the endotracheal tube cuff and the confirmation of the insertion of the intubation with capnography

Secondary outcomes

1

Description
Systolic blood pressure
Timepoint
At the beginning of the study (baseline) and before laryngoscopy and in the first, third, fifth, and tenth minutes after laryngoscopy
Method of measurement
Monitoring device

2

Description
Diastolic blood pressure
Timepoint
At the beginning of the study (baseline) and before laryngoscopy and in the first, third, fifth, and tenth minutes after laryngoscopy
Method of measurement
Monitoring device

3

Description
Mean Arterial Pressure
Timepoint
At the beginning of the study (baseline) and before laryngoscopy and in the first, third, fifth, and tenth minutes after laryngoscopy
Method of measurement
Monitoring device

4

Description
Heart rate
Timepoint
At the beginning of the study (baseline) and before laryngoscopy and in the first, third, fifth, and tenth minutes after laryngoscopy
Method of measurement
Monitoring device

Intervention groups

1

Description
The first intervention group: Patients in the first group underwent intubation using the direct Macintosh laryngoscope with Macintosh blade No. 3.
Category
Treatment - Devices

2

Description
The second intervention group: Patients in the second group underwent intubation using GlideScope video laryngoscope.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Azim Honarmand
Street address
Motahari Street.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3234 6338
Email
honarmand@med.mui.a.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjooy Javanmard
Street address
Vice Chancellor for Research, School of Medicine, Hezar Jarib Street, Isfahan.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8597
Email
dean@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Isfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Azim Honarmand
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Al-Zahra Hospita, Sefeh Blvd., Tohid Street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
honarmand@med.mui.a.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Azim Honarmand
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Al-Zahra Hospita, Sefeh Blvd., Tohid Street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
honarmand@med.mui.a.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Jafari
Position
Non-faculty specialist physician
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Al-Zahra Hospita, Sefeh Blvd., Tohid Street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
Ailin.babaei@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
y. If you do not not want to provide more explanation please enter "There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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