- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03464929
Learning Curves for Airtraq Versus King Vision Laryngoscopes
February 25, 2019 updated by: Fundación para la Investigación Biosanitaria del Principado de Asturias
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
64
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Principado De Asturias
-
Oviedo, Principado De Asturias, Spain, 33011
- Hospital Universitario Central de Asturias (HUCA)
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Adult patients submitted to elective surgery under general anesthesia.
Description
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) physical status classification I-II.
- Elective surgery.
- General anesthesia required.
Exclusion Criteria:
- Bronchoaspiration risk.
- Pharmacological allergies.
- Craniofacial anomalies.
- Body mass index > 30.
- Prior history of airway management complications.
- Presence of clinical signs predictive of difficult intubation.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Airtraq indirect laryngoscopy
Intubation attempts using Airtraq device.
|
Attempt to intubation using the Airtraq device
|
King Vision indirect laryngoscopy
Intubation attempts using King Vision device
|
Attempt to intubation using the King Vision device
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
60 seconds
|
Glottic visualization
Time Frame: 60 seconds
|
Scale of glottic visualization achieved
|
60 seconds
|
Intubation success
Time Frame: 60 seconds
|
Percentage of intubation success
|
60 seconds
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Félix Ezequiel Fernández-Suárez, MD, Hospital Universitario Central de Asturias
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Savoldelli 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 15, 2018
Primary Completion (Actual)
October 25, 2018
Study Completion (Actual)
February 25, 2019
Study Registration Dates
First Submitted
March 8, 2018
First Submitted That Met QC Criteria
March 8, 2018
First Posted (Actual)
March 14, 2018
Study Record Updates
Last Update Posted (Actual)
February 26, 2019
Last Update Submitted That Met QC Criteria
February 25, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- ISPA_CritLab_2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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