VideolaryngoscopyNCT03495596
Predictors of Difficult Videolaryngoscopy
An observational study of Videolaryngoscopy, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The primary goal of this study was to identify parameters affecting the failure of videolaryngoscopy in clinical practice; secondly, the incidence of videolaryngoscopy use and the most frequently used patient groups. Read more about this study
- Who is it for?
- Ages 1 day to 95 years
- Conditions the study is for
- Videolaryngoscopy
- What is being tested?
- Videolaryngoscopy
- Type of treatment
- Medical device
- How many people
- 1,159 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Jan 2018to 1 Mar 2020
- 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 1 day to 95 years
- All sexes
- Child, Adult, Older adult
Study population: Patients who will undergo surgery under general anesthesia will be followed in Hacettepe University Hospital's operating room. All patients aged 0-95 years who used videolaryngoscopy will be included in the study.
Who may be able to join
- All patients who used videolaryngoscopy for intubation
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determination of Factors Leading to Failure of Videolaryngoscopy
The primary goal of this study was to identify parameters affecting the failure of videolaryngoscopy in clinical practice; secondly, the incidence of videolaryngoscopy use and the most frequently used patient groups.
Read the detailed description
Videolaryngoscopy is widely used in the management of patients with presumed difficult airway. It offers an improved laryngeal view compared with direct laryngoscopy and increases the likelihood of successful intubation in patients for whom direct laryngoscopy is anticipated to be difficult. It is among the most frequently preferred difficult airway devices due to its ease of use, portability and direct laryngoscopy resemblance. The use of videolaryngoscopy has been shown to improve intubation success in many cases associated with difficult intubation, such as morbid obesity, pregnancy, limitation of cervical motility, and poor mouth opening.
- Conditions
- Videolaryngoscopy
- Being tested
- Videolaryngoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VideolaryngoscopyDevice
Videolaryngoscopy device type
| Study group | Role | What they receive |
|---|---|---|
| Videolaryngoscopy patients | The patients who were attempted to be intubated with videolaryngoscopy Receives: Device: Videolaryngoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation success
The success of intubation attempt with videolaryngoscopy (yes/no)
Measured: 15 minutes
Secondary outcomes (4)
The reason of videolaryngoscopy
Why videolaryngoscopy is preferred instead of standard direct laryngoscopy
Measured: 15 minutes
The type of videolaryngoscopy blade
acute angled/macintosh/miller blade
Measured: 15 minutes
The rescue technique
The rescue technique used for patients who could not be intubated with videolaryngoscopy
Measured: 30 minutes
Factors affecting success of videolaryngoscopy
Mallampati score, thyromental distance, neck movements, upper lip bite test, mouth opening
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2018
- Study start17 Jan 2018
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for VideolaryngoscopyStudies 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
- Cross-sectional
- Enrolment
- 1,159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevilay Kivrakoglu, Hacettepe University
- Investigators
- Aysun Ankay Yilbas, MD, Study director, Turkish Society of Anesthesiology and ReanimationSevilay Kivrakoglu, MD, Principal investigator, Turkish Society of Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03495596
- Sponsor's protocol ID
- Videolaryngoscopy
- Status last verified
- Apr 2022
- First submitted
- 5 Apr 2018
- Last updated
- 12 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Aziz MF, Bayman EO, Van Tienderen MM, Todd MM; StAGE Investigator Group; Brambrink AM. Predictors of difficult videolaryngoscopy with GlideScope(R) or C-MAC(R) with D-blade: secondary analysis from a large comparative videolaryngoscopy trial. Br J Anaesth. 2016 Jul;117(1):118-23. doi: 10.1093/bja/aew128.
PubMed 27317711el-Ganzouri AR, McCarthy RJ, Tuman KJ, Tanck EN, Ivankovich AD. Preoperative airway assessment: predictive value of a multivariate risk index. Anesth Analg. 1996 Jun;82(6):1197-204. doi: 10.1097/00000539-199606000-00017.
PubMed 8638791Aziz MF, Healy D, Kheterpal S, Fu RF, Dillman D, Brambrink AM. Routine clinical practice effectiveness of the Glidescope in difficult airway management: an analysis of 2,004 Glidescope intubations, complications, and failures from two institutions. Anesthesiology. 2011 Jan;114(1):34-41. doi: 10.1097/ALN.0b013e3182023eb7.
PubMed 21150569Toshniwal G, McKelvey GM, Wang H. STOP-Bang and prediction of difficult airway in obese patients. J Clin Anesth. 2014 Aug;26(5):360-7. doi: 10.1016/j.jclinane.2014.01.010. Epub 2014 Jul 28.
PubMed 25081584Nakao K, Komasawa N, Kusaka Y, Minami T. Rapid-Sequence Intubation in the Left-Lateral Tilt Position in a Pregnant Woman with Premature Placental Abruption Utilizing a Videolaryngoscope. AJP Rep. 2015 Apr;5(1):e30-2. doi: 10.1055/s-0034-1544109. Epub 2015 Feb 25.
PubMed 26199794Kleine-Brueggeney M, Greif R, Schoettker P, Savoldelli GL, Nabecker S, Theiler LG. Evaluation of six videolaryngoscopes in 720 patients with a simulated difficult airway: a multicentre randomized controlled trial. Br J Anaesth. 2016 May;116(5):670-9. doi: 10.1093/bja/aew058.
PubMed 27106971Mallampati SR, Gatt SP, Gugino LD, Desai SP, Waraksa B, Freiberger D, Liu PL. A clinical sign to predict difficult tracheal intubation: a prospective study. Can Anaesth Soc J. 1985 Jul;32(4):429-34. doi: 10.1007/BF03011357.
PubMed 4027773Wilson ME, Spiegelhalter D, Robertson JA, Lesser P. Predicting difficult intubation. Br J Anaesth. 1988 Aug;61(2):211-6. doi: 10.1093/bja/61.2.211.
PubMed 3415893Nath G, Sekar M. Predicting difficult intubation--a comprehensive scoring system. Anaesth Intensive Care. 1997 Oct;25(5):482-6. doi: 10.1177/0310057X9702500505.
PubMed 9352759Benumof JL. Management of the difficult adult airway. With special emphasis on awake tracheal intubation. Anesthesiology. 1991 Dec;75(6):1087-110. doi: 10.1097/00000542-199112000-00021.
PubMed 1824555Williamson JA, Webb RK, Szekely S, Gillies ER, Dreosti AV. The Australian Incident Monitoring Study. Difficult intubation: an analysis of 2000 incident reports. Anaesth Intensive Care. 1993 Oct;21(5):602-7. doi: 10.1177/0310057X9302100518.
PubMed 8273882Nichol HC, Zuck D. Difficult laryngoscopy--the "anterior" larynx and the atlanto-occipital gap. Br J Anaesth. 1983 Feb;55(2):141-4. doi: 10.1093/bja/55.2.141.
PubMed 6830676Oates JD, Macleod AD, Oates PD, Pearsall FJ, Howie JC, Murray GD. Comparison of two methods for predicting difficult intubation. Br J Anaesth. 1991 Mar;66(3):305-9. doi: 10.1093/bja/66.3.305.
PubMed 2015145Charters P, Perera S, Horton WA. Visibility of pharyngeal structures as a predictor of difficult intubation. Anaesthesia. 1987 Oct;42(10):1115. doi: 10.1111/j.1365-2044.1987.tb05182.x. No abstract available.
PubMed 3688398Cormack RS, Lehane J. Difficult tracheal intubation in obstetrics. Anaesthesia. 1984 Nov;39(11):1105-11.
PubMed 6507827
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Factors Leading to Failure of Videolaryngoscopy
- ClinicalTrials.gov ID
- NCT03495596
- Acronym / sponsor ID
- Videolaryngoscopy
- Conditions
- Videolaryngoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,159 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 17 Jan 2018 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 12 Apr 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.
The primary goal of this study was to identify parameters affecting the failure of videolaryngoscopy in clinical practice; secondly, the incidence of videolaryngoscopy use and the most frequently used patient groups.
Detailed description
Videolaryngoscopy is widely used in the management of patients with presumed difficult airway. It offers an improved laryngeal view compared with direct laryngoscopy and increases the likelihood of successful intubation in patients for whom direct laryngoscopy is anticipated to be difficult. It is among the most frequently preferred difficult airway devices due to its ease of use, portability and direct laryngoscopy resemblance. The use of videolaryngoscopy has been shown to improve intubation success in many cases associated with difficult intubation, such as morbid obesity, pregnancy, limitation of cervical motility, and poor mouth opening.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Videolaryngoscopy patients | – | Device: VideolaryngoscopyThe patients who were attempted to be intubated with videolaryngoscopy |
Who may qualify
- Ages
- 1 day to 95 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who will undergo surgery under general anesthesia will be followed in Hacettepe University Hospital's operating room. All patients aged 0-95 years who used videolaryngoscopy will be included in the study.
Key inclusion criteria (1 listed)
- All patients who used videolaryngoscopy for intubation
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| VideolaryngoscopyVideolaryngoscopy device type | Device | Videolaryngoscopy patients |
Primary outcome
Intubation success
Time frame: 15 minutes
The success of intubation attempt with videolaryngoscopy (yes/no)
4 secondary outcomes
The reason of videolaryngoscopy
Time frame: 15 minutes
The type of videolaryngoscopy blade
Time frame: 15 minutes
The rescue technique
Time frame: 30 minutes
Factors affecting success of videolaryngoscopy
Time frame: 30 minutes
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 12 Apr 2022.
- Background: PubMed 27317711Aziz MF, Bayman EO, Van Tienderen MM, Todd MM; StAGE Investigator Group; Brambrink AM. Predictors of difficult videolaryngoscopy with GlideScope(R) or C-MAC(R) with D-blade: secondary analysis from a large comparative videolaryngoscopy trial. Br J Anaesth. 2016 Jul;117(1):118-23. doi: 10.1093/bja/aew128.
- Background: PubMed 8638791el-Ganzouri AR, McCarthy RJ, Tuman KJ, Tanck EN, Ivankovich AD. Preoperative airway assessment: predictive value of a multivariate risk index. Anesth Analg. 1996 Jun;82(6):1197-204. doi: 10.1097/00000539-199606000-00017.
- Background: PubMed 21150569Aziz MF, Healy D, Kheterpal S, Fu RF, Dillman D, Brambrink AM. Routine clinical practice effectiveness of the Glidescope in difficult airway management: an analysis of 2,004 Glidescope intubations, complications, and failures from two institutions. Anesthesiology. 2011 Jan;114(1):34-41. doi: 10.1097/ALN.0b013e3182023eb7.
- Background: PubMed 25081584Toshniwal G, McKelvey GM, Wang H. STOP-Bang and prediction of difficult airway in obese patients. J Clin Anesth. 2014 Aug;26(5):360-7. doi: 10.1016/j.jclinane.2014.01.010. Epub 2014 Jul 28.
- Background: PubMed 26199794Nakao K, Komasawa N, Kusaka Y, Minami T. Rapid-Sequence Intubation in the Left-Lateral Tilt Position in a Pregnant Woman with Premature Placental Abruption Utilizing a Videolaryngoscope. AJP Rep. 2015 Apr;5(1):e30-2. doi: 10.1055/s-0034-1544109. Epub 2015 Feb 25.
- Background: PubMed 27106971Kleine-Brueggeney M, Greif R, Schoettker P, Savoldelli GL, Nabecker S, Theiler LG. Evaluation of six videolaryngoscopes in 720 patients with a simulated difficult airway: a multicentre randomized controlled trial. Br J Anaesth. 2016 May;116(5):670-9. doi: 10.1093/bja/aew058.
- Background: PubMed 4027773Mallampati SR, Gatt SP, Gugino LD, Desai SP, Waraksa B, Freiberger D, Liu PL. A clinical sign to predict difficult tracheal intubation: a prospective study. Can Anaesth Soc J. 1985 Jul;32(4):429-34. doi: 10.1007/BF03011357.
- Background: PubMed 3415893Wilson ME, Spiegelhalter D, Robertson JA, Lesser P. Predicting difficult intubation. Br J Anaesth. 1988 Aug;61(2):211-6. doi: 10.1093/bja/61.2.211.
- Background: PubMed 9352759Nath G, Sekar M. Predicting difficult intubation--a comprehensive scoring system. Anaesth Intensive Care. 1997 Oct;25(5):482-6. doi: 10.1177/0310057X9702500505.
- Background: PubMed 1824555Benumof JL. Management of the difficult adult airway. With special emphasis on awake tracheal intubation. Anesthesiology. 1991 Dec;75(6):1087-110. doi: 10.1097/00000542-199112000-00021.
- Background: PubMed 8273882Williamson JA, Webb RK, Szekely S, Gillies ER, Dreosti AV. The Australian Incident Monitoring Study. Difficult intubation: an analysis of 2000 incident reports. Anaesth Intensive Care. 1993 Oct;21(5):602-7. doi: 10.1177/0310057X9302100518.
- Background: PubMed 6830676Nichol HC, Zuck D. Difficult laryngoscopy--the "anterior" larynx and the atlanto-occipital gap. Br J Anaesth. 1983 Feb;55(2):141-4. doi: 10.1093/bja/55.2.141.
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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.
Aysun Ankay Yilbas, MD study director
Turkish Society of Anesthesiology and Reanimation
Sevilay Kivrakoglu, MD principal investigator
Turkish Society of Anesthesiology and Reanimation
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 Videolaryngoscopy, run by Hacettepe 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 12 Apr 2022. 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 success (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03495596, which also lists 15 linked publications.
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 12 Apr 2022.