IntubationNCT03677505
KoMAC Videolaryngoscope for Double-lumen Intubation
A study testing KoMAC videolaryngoscope and Macintosh Laryngoscope in people with Intubation, run by Ajou University School of Medicine at 1 site in South Korea.
Trial summary
KoMAC videolaryngoscope is a portable intubating device with an angulated single-use blade of adjustable size and a liquid crystal display monitor mounted on top of the handle, which is similar in shape to the McGrath videolaryngoscope. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Intubation
- What is being tested?
- KoMAC videolaryngoscope and Macintosh Laryngoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Oct 2018to 2 Mar 2020
- 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 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients scheduled for thoracic surgery requiring one lung ventilation
Who cannot join
- predicted difficult airway
- rapid sequence intubation
- cervical injury
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the KoMAC Videolaryngoscope With the Macintosh Laryngoscope for Double-lumen Intubation
KoMAC videolaryngoscope is a portable intubating device with an angulated single-use blade of adjustable size and a liquid crystal display monitor mounted on top of the handle, which is similar in shape to the McGrath videolaryngoscope. The purpose of this study was to evaluate the efficacy of the KoMAC videolaryngoscope for double-lumen intubation regarding intubation time, laryngeal view and ease of intubation, compared to Macintosh laryngoscope.
- Conditions
- Intubation
- Being tested
- KoMAC videolaryngoscope, Macintosh Laryngoscope
- Keywords
- double lumen intubation, videolaryngoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KoMAC videolaryngoscopeDevice
Double lumen endotracheal intubation was performed with the KoMAC videolaryngoscope
Macintosh LaryngoscopeDevice
Double lumen endotracheal intubation was performed with the Macintosh Laryngoscope
| Study group | Role | What they receive |
|---|---|---|
| KoMAC group | Experimental | Orotracheal intubation with KoMAC videolaryngoscope Receives: Device: KoMAC videolaryngoscope |
| Macintosh group | Active comparator | Orotracheal intubation with Macintosh laryngoscope Receives: Device: Macintosh Laryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation time
Time interval between laryngoscope passing the teeth to the confirming of end tidal CO2
Measured: from 2 min after rocuronium injection to completion of intubation (time interval is about 120 seconds)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2018
- Study start5 Oct 2018
- Primary completion27 Feb 2020
- Study completion2 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IntubationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jong Yeop Kim, Ajou University School of Medicine
- Investigators
- Jong Yeop Kim, Principal investigator, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03677505
- Sponsor's protocol ID
- AJIRB-MED-OBS-18-286
- Status last verified
- Mar 2020
- First submitted
- 18 Sep 2018
- Last updated
- 11 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the KoMAC Videolaryngoscope With the Macintosh Laryngoscope for Double-lumen Intubation
- ClinicalTrials.gov ID
- NCT03677505
- Acronym / sponsor ID
- AJIRB-MED-OBS-18-286
- Conditions
- Intubation
- Keywords
- double lumen intubation, videolaryngoscope
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- 5 Oct 2018 (actual)
- Primary completion
- 27 Feb 2020 (actual)
- Study completion
- 2 Mar 2020 (actual)
- First posted
- 19 Sep 2018 (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.
KoMAC videolaryngoscope is a portable intubating device with an angulated single-use blade of adjustable size and a liquid crystal display monitor mounted on top of the handle, which is similar in shape to the McGrath videolaryngoscope. The purpose of this study was to evaluate the efficacy of the KoMAC videolaryngoscope for double-lumen intubation regarding intubation time, laryngeal view and ease of intubation, compared to Macintosh laryngoscope.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KoMAC group | Experimental | Device: KoMAC videolaryngoscopeOrotracheal intubation with KoMAC videolaryngoscope |
| Macintosh group | Active comparator | Device: Macintosh LaryngoscopeOrotracheal intubation with Macintosh laryngoscope |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients scheduled for thoracic surgery requiring one lung ventilation
Key exclusion criteria (3 listed)
- predicted difficult airway
- rapid sequence intubation
- cervical injury
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 |
|---|---|---|
| KoMAC videolaryngoscopeDouble lumen endotracheal intubation was performed with the KoMAC videolaryngoscope | Device | KoMAC group |
| Macintosh LaryngoscopeDouble lumen endotracheal intubation was performed with the Macintosh Laryngoscope | Device | Macintosh group |
Primary outcome
Intubation time
Time frame: from 2 min after rocuronium injection to completion of intubation (time interval is about 120 seconds)
Time interval between laryngoscope passing the teeth to the confirming of end tidal CO2
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 11 Mar 2020.
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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.
Jong Yeop Kim principal investigator
Ajou University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KoMAC videolaryngoscope and Macintosh Laryngoscope in people with Intubation, run by Ajou University School of Medicine 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 3 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 11 Mar 2020. 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: from 2 min after rocuronium injection to completion of intubation (time interval is about 120 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 11 Mar 2020.