ObesityNCT05146531
Comparison of McCoy Laryngoscope and C-MAC D-blade Video Laryngoscope in Obese Patients
A study testing McCoy laryngoscope and C-MAC D-blade video laryngoscope in people with Obesity, run by Eun Young Park at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- McCoy laryngoscope and C-MAC D-blade video laryngoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Dec 2019to 5 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- American society of anesthesiologists physical status of I-II patients with BMI ≥ 35 kg/m² scheduled for general anesthesia
Who cannot join
- patients with tracheal diseases, sore throat, neck pain and loose tooth.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Hallym university sacred heart hospital
Anyang-si, Gyeonggi-do, 14066
About this study
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.
- Conditions
- Obesity
- Being tested
- McCoy laryngoscope, C-MAC D-blade video laryngoscope
- Keywords
- obesity, intubation, laryngoscopes
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
McCoy laryngoscopeDevice
Patients scheduled for general anesthesia were intubated with McCoy laryngoscope.
C-MAC D-blade video laryngoscopeDevice
Patients scheduled for general anesthesia were intubated with C-MAC D-blade video laryngoscope.
| Study group | Role | What they receive |
|---|---|---|
| McCoy group | Active comparator | Patients were intubated with McCoy laryngoscope. Receives: Device: McCoy laryngoscope |
| C-MAC group | Experimental | Patients were intubated with C-MAC D-blade video laryngoscope. Receives: Device: C-MAC D-blade video laryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The patients were excluded in this study if intubation time was over 90 seconds.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2021
- Study start6 Dec 2019
- Primary completion5 Aug 2021
- Study completion5 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eun Young Park
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eun Young Park, Hallym University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05146531
- Sponsor's protocol ID
- 2019-10-010
- Status last verified
- Dec 2021
- First submitted
- 18 Nov 2021
- Last updated
- 6 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of McCoy Laryngoscope and C-MAC D-blade Video Laryngoscope in Obese Patients
- ClinicalTrials.gov ID
- NCT05146531
- Acronym / sponsor ID
- 2019-10-010
- Conditions
- Obesity
- Keywords
- obesity, intubation, laryngoscopes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Eun Young ParkUniversity, hospital or other
- Study start
- 6 Dec 2019 (actual)
- Primary completion
- 5 Aug 2021 (actual)
- Study completion
- 5 Aug 2021 (actual)
- First posted
- 6 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| McCoy group | Active comparator | Device: McCoy laryngoscopePatients were intubated with McCoy laryngoscope. |
| C-MAC group | Experimental | Device: C-MAC D-blade video laryngoscopePatients were intubated with C-MAC D-blade video laryngoscope. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- American society of anesthesiologists physical status of I-II patients with BMI ≥ 35 kg/m² scheduled for general anesthesia
Key exclusion criteria (1 listed)
- patients with tracheal diseases, sore throat, neck pain and loose tooth.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| McCoy laryngoscopePatients scheduled for general anesthesia were intubated with McCoy laryngoscope. | Device | McCoy group |
| C-MAC D-blade video laryngoscopePatients scheduled for general anesthesia were intubated with C-MAC D-blade video laryngoscope. | Device | C-MAC group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing McCoy laryngoscope and C-MAC D-blade video laryngoscope in people with Obesity, run by Eun Young Park at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intubation time (time frame: The patients were excluded in this study if intubation time was over 90 seconds.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2021.