Back to resultsComparison of McCoy Laryngoscope and C-MAC D-blade Video Laryngoscope in Obese Patients
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
McCoy laryngoscope
C-MAC D-blade video laryngoscope
Sponsored by
About this trial
This is an interventional supportive care trial for Obesity focused on measuring obesity, intubation, laryngoscopes
Eligibility Criteria
Inclusion Criteria:
- American society of anesthesiologists physical status of I-II patients with BMI ≥ 35 kg/m² scheduled for general anesthesia
Exclusion Criteria:
- patients with tracheal diseases, sore throat, neck pain and loose tooth.
Sites / Locations
- Hallym university sacred heart hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
McCoy group
C-MAC group
Arm Description
Patients were intubated with McCoy laryngoscope.
Patients were intubated with C-MAC D-blade video laryngoscope.
Outcomes
Primary Outcome Measures
Intubation time
Timing measurement began when the laryngoscope blade was inserted in patients' mouth and ended when end tidal carbon dioxide tracing was detected in the monitor.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05146531
Brief Title
Comparison of McCoy Laryngoscope and C-MAC D-blade Video Laryngoscope in Obese Patients
Official Title
Comparison of McCoy Laryngoscope and C-MAC D-blade Video Laryngoscope in Obese Patients
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
December 6, 2019 (Actual)
Primary Completion Date
August 5, 2021 (Actual)
Study Completion Date
August 5, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Eun Young Park
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Obesity is associated with difficult intubation rate of 30%, and this study was performed to compare the use of McCoy laryngoscope and C-MAC D-blade video laryngoscope for intubation in obese patients. A total 104 patients with body mass index (BMI) ≥ 35kg/m² scheduled for general anesthesia were randomly assigned to be intubated with McCoy laryngoscope or C-MAC D-blade video laryngoscope. The primary outcome was intubation time, and secondary outcomes were mask ventilation scale, intubation difficulty scale (IDS), percentage of glottis opening (POGO) score, and hemodynamic variables including mean arterial pressure, heart rate and saturation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
obesity, intubation, laryngoscopes
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
104 (Actual)
8. Arms, Groups, and Interventions
Arm Title
McCoy group
Arm Type
Active Comparator
Arm Description
Patients were intubated with McCoy laryngoscope.
Arm Title
C-MAC group
Arm Type
Experimental
Arm Description
Patients were intubated with C-MAC D-blade video laryngoscope.
Intervention Type
Device
Intervention Name(s)
McCoy laryngoscope
Intervention Description
Patients scheduled for general anesthesia were intubated with McCoy laryngoscope.
Intervention Type
Device
Intervention Name(s)
C-MAC D-blade video laryngoscope
Intervention Description
Patients scheduled for general anesthesia were intubated with C-MAC D-blade video laryngoscope.
Primary Outcome Measure Information:
Title
Intubation time
Description
Timing measurement began when the laryngoscope blade was inserted in patients' mouth and ended when end tidal carbon dioxide tracing was detected in the monitor.
Time Frame
The patients were excluded in this study if intubation time was over 90 seconds.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
American society of anesthesiologists physical status of I-II patients with BMI ≥ 35 kg/m² scheduled for general anesthesia
Exclusion Criteria:
patients with tracheal diseases, sore throat, neck pain and loose tooth.
Facility Information:
Facility Name
Hallym university sacred heart hospital
City
Anyang-si
State/Province
Gyeonggi-do
ZIP/Postal Code
14066
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of McCoy Laryngoscope and C-MAC D-blade Video Laryngoscope in Obese Patients
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