NCT03464929

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 14, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2019

Completed
Last Updated

February 26, 2019

Status Verified

February 1, 2019

Enrollment Period

9 months

First QC Date

March 8, 2018

Last Update Submit

February 25, 2019

Conditions

IntubationLaryngoscopy

Outcome Measures

Primary Outcomes (3)

  • Time for intubation

    Time required from the insertion of the blade beyond the incisors until one complete wave pattern of capnography is monitored.

    60 seconds

  • Glottic visualization

    Scale of glottic visualization achieved

    60 seconds

  • Intubation success

    Percentage of intubation success

    60 seconds

Study Arms (2)

Airtraq indirect laryngoscopy

Intubation attempts using Airtraq device.

Device: Airtraq indirect laryngoscopy

King Vision indirect laryngoscopy

Intubation attempts using King Vision device

Device: King Vision indirect laryngoscopy

Interventions

Airtraq indirect laryngoscopyDEVICE

Attempt to intubation using the Airtraq device

Airtraq indirect laryngoscopy
King Vision indirect laryngoscopyDEVICE

Attempt to intubation using the King Vision device

King Vision indirect laryngoscopy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients submitted to elective surgery under general anesthesia.

You may qualify if:

  • American Society of Anesthesiologists (ASA) physical status classification I-II.
  • Elective surgery.
  • General anesthesia required.

You may not qualify if:

  • Bronchoaspiration risk.
  • Pharmacological allergies.
  • Craniofacial anomalies.
  • Body mass index \> 30.
  • Prior history of airway management complications.
  • Presence of clinical signs predictive of difficult intubation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Central de Asturias (HUCA)

Oviedo, Principality of Asturias, 33011, Spain

Location

Related Publications (2)

  • 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.

    PMID: 21897263BACKGROUND

  • 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.

    PMID: 19522050BACKGROUND

Study Officials

  • Félix Ezequiel Fernández-Suárez, MD

    Hospital Universitario Central de Asturias

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2018

First Posted

March 14, 2018

Study Start

January 15, 2018

Primary Completion

October 25, 2018

Study Completion

February 25, 2019

Last Updated

February 26, 2019

Record last verified: 2019-02

Locations

ES(1)