- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05146531
Comparison of McCoy Laryngoscope and C-MAC D-blade Video Laryngoscope in Obese Patients
December 3, 2021 updated by: Eun Young Park
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
104
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Gyeonggi-do
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Anyang-si, Gyeonggi-do, Korea, Republic of, 14066
- Hallym University Sacred Heart Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: McCoy group
Patients were intubated with McCoy laryngoscope.
|
Patients scheduled for general anesthesia were intubated with McCoy laryngoscope.
|
Experimental: C-MAC group
Patients were intubated with C-MAC D-blade video laryngoscope.
|
Patients scheduled for general anesthesia were intubated with C-MAC D-blade video laryngoscope.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intubation time
Time Frame: The patients were excluded in this study if intubation time was over 90 seconds.
|
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.
|
The patients were excluded in this study if intubation time was over 90 seconds.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 6, 2019
Primary Completion (Actual)
August 5, 2021
Study Completion (Actual)
August 5, 2021
Study Registration Dates
First Submitted
November 18, 2021
First Submitted That Met QC Criteria
December 3, 2021
First Posted (Actual)
December 6, 2021
Study Record Updates
Last Update Posted (Actual)
December 6, 2021
Last Update Submitted That Met QC Criteria
December 3, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-10-010
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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