IntubationNCT05967338
Glottis Visualization in Different Lifting Methods
An observational study of Intubation and Glottis Visualization, run by Zonguldak Bulent Ecevit University at 1 site in Turkey (Türkiye).
Trial summary
Among the various types of video laryngoscopes, the McGrath MAC video laryngoscopy (VL) has become popular because it is lightweight and can be quickly and hygienically prepared by changing the blade. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Intubation, Glottis Visualization
- What is being tested?
- using McGrath Video Laryngoscope
- Type of treatment
- Medical device
- How many people
- 1 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2022to 1 Mar 2023
- Phase
- Observational
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: ASA I-II, 18-65 years old patients undergoing elective surgery
Who may be able to join
- ASA I-II
- general anesthesia in elective surgeries
- 18-65 years old
- body mass index (25-30)
- no risk of difficult intubation
Who cannot join
- Allergic to study drugs
- pregnant women
- emergency cases
- those with a history of difficult intubation
- those without consent
- those at risk of aspiration
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zonguldak Bülent Ecevit University
Zonguldak, Kozlu, 67600
About this study
Official title: Comparison of Epiglottis Lifting Methods Using a McGrath Video Laryngoscope: Direct vs. Indirect
Among the various types of video laryngoscopes, the McGrath MAC video laryngoscopy (VL) has become popular because it is lightweight and can be quickly and hygienically prepared by changing the blade. The aim of this study was to compare the efficacy of two different methods (direct and indirect) for epiglottis removal during visualization of the glottis using the McGrath MAC VL.
- Conditions
- Intubation, Glottis Visualization
- Being tested
- using McGrath Video Laryngoscope
- Keywords
- Endotrakeal intubation, Epiglottis, Glottis, McGrath MAC video laryngoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
using McGrath Video LaryngoscopeDevice
glottis visualization in indirect and direct lifting methods by using McGrath Video Laryngoscope
| Study group | Role | What they receive |
|---|---|---|
| Group Direct | glottis visualization in direct lifting Receives: Device: using McGrath Video Laryngoscope | |
| Group Indirect | glottis visualization in indirect lifting Receives: Device: using McGrath Video Laryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
POGO scores
percentage of glottic opening
Measured: 1 day (through intubation )
Secondary outcomes (1)
Cormack-Lehane classification
assessment of laryngeal view during laryngoscopy
Measured: 1 day (through intubation )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start1 Jul 2022
- Primary completion30 Jan 2023
- Study completion1 Mar 2023
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zonguldak Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keziban Bollucuoglu, Zonguldak Bulent Ecevit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05967338
- Sponsor's protocol ID
- 2022/12-10
- Status last verified
- Jul 2023
- First submitted
- 1 Jun 2023
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- 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 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Epiglottis Lifting Methods Using a McGrath Video Laryngoscope: Direct vs. Indirect
- ClinicalTrials.gov ID
- NCT05967338
- Acronym / sponsor ID
- 2022/12-10
- Conditions
- Intubation, Glottis Visualization
- Keywords
- Endotrakeal intubation, Epiglottis, Glottis, McGrath MAC video laryngoscope
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Zonguldak Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 1 Aug 2023 (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.
Among the various types of video laryngoscopes, the McGrath MAC video laryngoscopy (VL) has become popular because it is lightweight and can be quickly and hygienically prepared by changing the blade. The aim of this study was to compare the efficacy of two different methods (direct and indirect) for epiglottis removal during visualization of the glottis using the McGrath MAC VL.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Direct | – | Device: using McGrath Video Laryngoscopeglottis visualization in direct lifting |
| Group Indirect | – | Device: using McGrath Video Laryngoscopeglottis visualization in indirect lifting |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- ASA I-II, 18-65 years old patients undergoing elective surgery
Key inclusion criteria (5 listed)
- ASA I-II
- general anesthesia in elective surgeries
- 18-65 years old
- body mass index (25-30)
- no risk of difficult intubation
Key exclusion criteria (6 listed)
- Allergic to study drugs
- pregnant women
- emergency cases
- those with a history of difficult intubation
- those without consent
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 |
|---|---|---|
| using McGrath Video Laryngoscopeglottis visualization in indirect and direct lifting methods by using McGrath Video Laryngoscope | Device | Group Direct, Group Indirect |
Primary outcome
POGO scores
Time frame: 1 day (through intubation )
percentage of glottic opening
1 secondary outcome
Cormack-Lehane classification
Time frame: 1 day (through intubation )
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 1 Aug 2023.
- 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?
An observational study of Intubation and Glottis Visualization, run by Zonguldak Bulent Ecevit University at 1 site in Turkey (Türkiye).
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 5 inclusion and 6 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 1 Aug 2023. 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 Turkey (Türkiye). 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?
POGO scores (time frame: 1 day (through intubation )). 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 1 Aug 2023.