Difficult Airway, VideolaryngoscopesNCT03402581
The Effect of Different Videolaryngoscopes on Intubation Success in Obese Patients
An observational study of Difficult Airway, Videolaryngoscopes, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
Obese patients may have difficulty in airway management.Patients who have body mass index > 35 are challenging patients for anesthesiologist. Short neck, more adipose tissue may be reasons for airway difficulty. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Difficult Airway, Videolaryngoscopes
- What is being tested?
- c-mac laryngoscope
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Sep 2018to 1 Dec 2018
- How long will I take part?
- 1 Year
- 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 undergoing elective surgery and have body mass index > 35
Who may be able to join
- body mass index> 35
Who cannot join
- emergency airway
Trial locations and contacts
1 site in 1 country.
About this study
Obese patients may have difficulty in airway management.Patients who have body mass index > 35 are challenging patients for anesthesiologist. Short neck, more adipose tissue may be reasons for airway difficulty. Videolaryngoscopes are devices that ease the management of difficult airway.This study is designed to evaluate the differences and the effects of different laryngoscopes.
- Conditions
- Difficult Airway, Videolaryngoscopes
- Being tested
- c-mac laryngoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
c-mac laryngoscopeDevice
Also called mc-grath laryngoscope
type of laryngoscopes
| Study group | Role | What they receive |
|---|---|---|
| c-mac used for intubation | obese patients intubated with c-mac videolaryngoscope Receives: Device: c-mac laryngoscope | |
| mc-grath used for intubation | obese patients intubated with mc-grath videolaryngoscope Receives: Device: c-mac laryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
intubation difficulty
the management of airway
Measured: 1 minute
Secondary outcomes (1)
airway assesment
evaluating the airway
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2018
- Study start2 Sep 2018
- Primary completion1 Dec 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Difficult Airway, VideolaryngoscopesStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 1 Year
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, Principal investigator, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03402581
- Sponsor's protocol ID
- 18-925-16
- Status last verified
- Feb 2020
- First submitted
- 11 Jan 2018
- Last updated
- 2 Mar 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 2 Mar 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 Obese Patients
- ClinicalTrials.gov ID
- NCT03402581
- Acronym / sponsor ID
- 18-925-16
- Conditions
- Difficult Airway, Videolaryngoscopes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 2 Sep 2018 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 18 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.
Obese patients may have difficulty in airway management.Patients who have body mass index > 35 are challenging patients for anesthesiologist. Short neck, more adipose tissue may be reasons for airway difficulty. Videolaryngoscopes are devices that ease the management of difficult airway.This study is designed to evaluate the differences and the effects of different laryngoscopes.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| c-mac used for intubation | – | Device: c-mac laryngoscopeobese patients intubated with c-mac videolaryngoscope |
| mc-grath used for intubation | – | Device: c-mac laryngoscopeobese patients intubated with mc-grath videolaryngoscope |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing elective surgery and have body mass index > 35
Key inclusion criteria (1 listed)
- body mass index> 35
Key exclusion criteria (1 listed)
- emergency airway
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 |
|---|---|---|
| c-mac laryngoscopeAlso: mc-grath laryngoscopetype of laryngoscopes | Device | c-mac used for intubation, mc-grath used for intubation |
Primary outcome
intubation difficulty
Time frame: 1 minute
the management of airway
1 secondary outcome
airway assesment
Time frame: 1 minute
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 2 Mar 2020.
- Individual participant dataSharing planned: No
Related trials for Difficult Airway, Videolaryngoscopes
Enrolling by invitation
Videolaryngoscopes in the Morbidly Obese
Obesity Difficult Airway Airway Management
RecruitingObservational study
PrediSuisse: Automatized Assessment of Difficult Airway
Anesthesia, Intubation; Difficult or Failed
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 principal investigator
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 Difficult Airway, Videolaryngoscopes, 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 2 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 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 difficulty (time frame: 1 minute). 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 2 Mar 2020.