Mallampati Score, Difficult Intubation, VideolaryngoscopeNCT03407898
The Effect of Different Videolaryngoscopes on Intubation Success in Difficult Airway Patients
An observational study of Mallampati Score, Difficult Intubation, Videolaryngoscope, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
Mallampati score > 3 generally indicate difficult airway and difficult intubation. Most anesthesiologist usually use this score system to predict difficult airway management. Different laryngoscopes may be useful in management of difficult airway. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mallampati Score, Difficult Intubation, Videolaryngoscope
- What is being tested?
- intubation time
- How many people
- 130 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 May 2018to 1 Nov 2018
- How long will I take part?
- 1 Day
- 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
- No healthy volunteers
- Adult, Older adult
Study population: patients who has mallampati score >3
Who may be able to join
- mallampati score >3
Who cannot join
- patient refusal
Trial locations and contacts
1 site in 1 country.
About this study
Mallampati score > 3 generally indicate difficult airway and difficult intubation. Most anesthesiologist usually use this score system to predict difficult airway management. Different laryngoscopes may be useful in management of difficult airway. This study designed to compare different videolaryngoscopes in intubation success in patient of Mallampati score>3.
- Being tested
- intubation time
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intubation timeOther
Also called intubation attempt
intubation attempt number and intubation time
| Study group | Role | What they receive |
|---|---|---|
| C-mac D blade used for intubation | Not described Receives: Other: intubation time | |
| mcgrath X blade used for intubation | Not described Receives: Other: intubation time |
What is being measured
The primary outcome is the main question the study is designed to answer.
intubation time
Measured: 60 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start2 May 2018
- Primary completion1 Sep 2018
- Study completion1 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mallampati Score, Difficult Intubation, VideolaryngoscopeStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 130 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CIGDEM YILDIRIM GUCLU, Ankara University
- Investigators
- CIGDEM YILDIRIMGUCLU, Study chair, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03407898
- Sponsor's protocol ID
- 20-1006-16
- Status last verified
- Feb 2020
- First submitted
- 17 Jan 2018
- Last updated
- 28 Feb 2020
- 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 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Videolaryngoscopes on Intubation Success in Difficult Airway Patients
- ClinicalTrials.gov ID
- NCT03407898
- Acronym / sponsor ID
- 20-1006-16
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 2 May 2018 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 23 Jan 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.
Mallampati score > 3 generally indicate difficult airway and difficult intubation. Most anesthesiologist usually use this score system to predict difficult airway management. Different laryngoscopes may be useful in management of difficult airway. This study designed to compare different videolaryngoscopes in intubation success in patient of Mallampati score>3.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| C-mac D blade used for intubation | – | Other: intubation time |
| mcgrath X blade used for intubation | – | Other: intubation time |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who has mallampati score >3
Key inclusion criteria (1 listed)
- mallampati score >3
Key exclusion criteria (1 listed)
- patient refusal
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 |
|---|---|---|
| intubation timeAlso: intubation attemptintubation attempt number and intubation time | Other | C-mac D blade used for intubation, mcgrath X blade used for intubation |
Primary outcome
intubation time
Time frame: 60 seconds
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 28 Feb 2020.
- Individual participant dataSharing planned: No
Related trials for Mallampati Score, Difficult Intubation, Videolaryngoscope
Not yet recruiting
Combined Ultrasonographic Skin-to-Epiglottis Distance With Modified Mallampati Versus Modified Mallampati Score Alone in Predicting Difficult Laryngoscopy During Tracheal Intubation Under General Anesthesia
Ultrasonographic, Mallampati Score
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.
CIGDEM YILDIRIMGUCLU study chair
Ankara University
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 Mallampati Score, Difficult Intubation, Videolaryngoscope, run by Ankara 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 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 28 Feb 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 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?
intubation time (time frame: 60 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 28 Feb 2020.