IntubationNCT03464929
Learning Curves for Airtraq Versus King Vision Laryngoscopes
An observational study of Intubation and Laryngoscopy, run by Fundación para la Investigación Biosanitaria del Principado de Asturias at 1 site in Spain.
Trial summary
Several videolaryngoscopes have been developed but few have been compared in terms of their learning curves and efficacy. The aim of this study is to compare the learning curves of Airtraq versus King Vision in a group of residents trained in direct laryngoscopy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intubation, Laryngoscopy
- What is being tested?
- Airtraq indirect laryngoscopy and King Vision indirect laryngoscopy
- Type of treatment
- Medical device
- How many people
- 64 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jan 2018to 25 Feb 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients submitted to elective surgery under general anesthesia.
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status classification I-II.
- Elective surgery.
- General anesthesia required.
Who cannot join
- Bronchoaspiration risk.
- Pharmacological allergies.
- Craniofacial anomalies.
- Body mass index > 30.
- Prior history of airway management complications.
- Presence of clinical signs predictive of difficult intubation.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitario Central de Asturias (HUCA)
Oviedo, Principality of Asturias, 33011
About this study
Several videolaryngoscopes have been developed but few have been compared in terms of their learning curves and efficacy. The aim of this study is to compare the learning curves of Airtraq versus King Vision in a group of residents trained in direct laryngoscopy. Four residents will perform, after a short training in manikin, 8 intubations with each device. The sequence of use of the devices will be randomized. Outcome measures will be duration of intubation attempt, glottic visualization and percentage of intubation success.
- Conditions
- Intubation, Laryngoscopy
- Being tested
- Airtraq indirect laryngoscopy, King Vision indirect laryngoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Airtraq indirect laryngoscopyDevice
Attempt to intubation using the Airtraq device
King Vision indirect laryngoscopyDevice
Attempt to intubation using the King Vision device
| Study group | Role | What they receive |
|---|---|---|
| Airtraq indirect laryngoscopy | Intubation attempts using Airtraq device. Receives: Device: Airtraq indirect laryngoscopy | |
| King Vision indirect laryngoscopy | Intubation attempts using King Vision device Receives: Device: King Vision indirect laryngoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time for intubation
Time required from the insertion of the blade beyond the incisors until one complete wave pattern of capnography is monitored.
Measured: 60 seconds
Glottic visualization
Scale of glottic visualization achieved
Measured: 60 seconds
Intubation success
Percentage of intubation success
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 posted14 Mar 2018
- Study start15 Jan 2018
- Primary completion25 Oct 2018
- Study completion25 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación para la Investigación Biosanitaria del Principado de Asturias
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario Central de Asturias, Fundación Asturcor
- Responsible party
- Sponsor
- Investigators
- Félix Ezequiel Fernández-Suárez, MD, Study director, Hospital Universitario Central de Asturias
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03464929
- Sponsor's protocol ID
- ISPA_CritLab_2
- Status last verified
- Feb 2019
- First submitted
- 8 Mar 2018
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Su YC, Chen CC, Lee YK, Lee JY, Lin KJ. Comparison of video laryngoscopes with direct laryngoscopy for tracheal intubation: a meta-analysis of randomised trials. Eur J Anaesthesiol. 2011 Nov;28(11):788-95. doi: 10.1097/EJA.0b013e32834a34f3.
PubMed 21897263Savoldelli GL, Schiffer E, Abegg C, Baeriswyl V, Clergue F, Waeber JL. Learning curves of the Glidescope, the McGrath and the Airtraq laryngoscopes: a manikin study. Eur J Anaesthesiol. 2009 Jul;26(7):554-8. doi: 10.1097/eja.0b013e3283269ff4.
PubMed 19522050
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Learning Curves for Airtraq Versus King Vision Laryngoscopes
- ClinicalTrials.gov ID
- NCT03464929
- Acronym / sponsor ID
- ISPA_CritLab_2
- Conditions
- Intubation, Laryngoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Fundación para la Investigación Biosanitaria del Principado de AsturiasUniversity, hospital or other
- Collaborators
- Hospital Universitario Central de Asturias, Fundación Asturcor
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 25 Oct 2018 (actual)
- Study completion
- 25 Feb 2019 (actual)
- First posted
- 14 Mar 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.
Several videolaryngoscopes have been developed but few have been compared in terms of their learning curves and efficacy. The aim of this study is to compare the learning curves of Airtraq versus King Vision in a group of residents trained in direct laryngoscopy. Four residents will perform, after a short training in manikin, 8 intubations with each device. The sequence of use of the devices will be randomized. Outcome measures will be duration of intubation attempt, glottic visualization and percentage of intubation success.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Airtraq indirect laryngoscopy | – | Device: Airtraq indirect laryngoscopyIntubation attempts using Airtraq device. |
| King Vision indirect laryngoscopy | – | Device: King Vision indirect laryngoscopyIntubation attempts using King Vision device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients submitted to elective surgery under general anesthesia.
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists (ASA) physical status classification I-II.
- Elective surgery.
- General anesthesia required.
Key exclusion criteria (6 listed)
- Bronchoaspiration risk.
- Pharmacological allergies.
- Craniofacial anomalies.
- Body mass index > 30.
- Prior history of airway management complications.
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 |
|---|---|---|
| Airtraq indirect laryngoscopyAttempt to intubation using the Airtraq device | Device | Airtraq indirect laryngoscopy |
| King Vision indirect laryngoscopyAttempt to intubation using the King Vision device | Device | King Vision indirect laryngoscopy |
Primary outcome
Time for intubation
Time frame: 60 seconds
Time required from the insertion of the blade beyond the incisors until one complete wave pattern of capnography is monitored.
Glottic visualization
Time frame: 60 seconds
Scale of glottic visualization achieved
Intubation success
Time frame: 60 seconds
Percentage of intubation success
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 26 Feb 2019.
- Background: PubMed 21897263Su YC, Chen CC, Lee YK, Lee JY, Lin KJ. Comparison of video laryngoscopes with direct laryngoscopy for tracheal intubation: a meta-analysis of randomised trials. Eur J Anaesthesiol. 2011 Nov;28(11):788-95. doi: 10.1097/EJA.0b013e32834a34f3.
- Background: PubMed 19522050Savoldelli GL, Schiffer E, Abegg C, Baeriswyl V, Clergue F, Waeber JL. Learning curves of the Glidescope, the McGrath and the Airtraq laryngoscopes: a manikin study. Eur J Anaesthesiol. 2009 Jul;26(7):554-8. doi: 10.1097/eja.0b013e3283269ff4.
- Individual participant dataSharing planned: Undecided
Related trials for Intubation
Not yet recruitingObservational study
LeHeR Maneuver vs Sniffing Position During Video Laryngoscopy in Predicted Difficult Airway
Difficult Airway, Difficult Intubation
Not yet recruitingObservational study
Sniffing Position vs Left Head Rotation (LeHeR) Maneuver for Glottic View During Direct Laryngoscopy
Difficult Intubation, Laryngoscopy
Recruiting
Hyperangulated vs. Macintosh Style Blades for Intubation in Obstetric Patients
Obstetric, Cesarean Birth
Not yet recruiting
AI Smart Glasses Feedback for Intubation Training in Medical Students
Intubation, Intratracheal, Medical Education
Not yet recruiting
Effect of a Brief Educational Intervention on Endotracheal Tube Cuff Pressure
Intubation, Endotracheal Tube Cuff Pressure
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.
Félix Ezequiel Fernández-Suárez, MD study director
Hospital Universitario Central de Asturias
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 Laryngoscopy, run by Fundación para la Investigación Biosanitaria del Principado de Asturias at 1 site in Spain.
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 3 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 26 Feb 2019. 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 Spain. 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?
Time for intubation (time frame: 60 seconds). The study lists 3 primary outcomes in all. 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 NCT03464929, which also lists 2 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 26 Feb 2019; AzTrials last refreshed its copy on 30 Oct 2026.