NCT01080118

Brief Summary

The use of the video laryngoscope to teach laryngoscopy will improve the performance of tracheal intubation done by novices because it will allow a shared view of the airway leading to a better feedback from the trainer to the trainee.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2010

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

February 1, 2010

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

February 26, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 3, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

September 4, 2013

Completed
Last Updated

December 2, 2013

Status Verified

October 1, 2013

Enrollment Period

1 year

First QC Date

February 26, 2010

Results QC Date

March 2, 2012

Last Update Submit

October 29, 2013

Conditions

Keywords

TeachingVideo ScopeIntubation

Outcome Measures

Primary Outcomes (1)

  • Successful Endotracheal Intubation

    A successful placement of the endotracheal tube as defined by the presence of bilateral breath sounds and positive recording of end tidal carbon dioxide.

    120 seconds

Secondary Outcomes (1)

  • Time to Intubation

    120 seconds

Study Arms (2)

control group

OTHER

Control group, taught with a standard Macintosh laryngoscope

Other: Control group, taught with a standard Macintosh laryngoscope

Study group

EXPERIMENTAL

Study group taught with the Airtraq video laryngoscope

Device: Airtraq

Interventions

AirtraqDEVICE

Subjects were taught with the Airtraq video laryngoscope

Study group

Subjects were taught how to use the Mackintosh blade first

control group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Medical student or intern rotating through the anesthesiology department

You may not qualify if:

  • Previous attempts of laryngoscopy in humans
  • Subject who refuses participation
  • Patients:
  • Age 18 -75 years of age
  • ASA PS I, II
  • Procedure that will require General anesthesia with tracheal intubation
  • Age \< 18 years old or greater than 75 years of age
  • Patient or student who refuses participation
  • ASA Physical status class III or greater
  • History of lung disease
  • History of obstructive sleep apnea
  • History of difficult intubation
  • Evidence of possible difficult airway (Mallampati Class \>2, TMH distance \<6 cm, mouth opening \<4 cm and limited neck mobility)
  • Unanticipated difficult laryngoscopy (defined by inability of the attending anesthesiology to intubate after 2 attempts)
  • Patients at risk for aspiration
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Limitations and Caveats

The intubating laryngeal mask airway the optical laryngoscope device used in this study does not allow for ventilation of the patient if intubation fails. We did not study retention of airway management skills between the groups.

Results Point of Contact

Title
Dr. Gildasio DeOliveira
Organization
Northwestern University Feinberg School of Medicine

Study Officials

  • Gildasio DeOliveira, MD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Gildasio De Oliveira, M.D. Principal Investigator

Study Record Dates

First Submitted

February 26, 2010

First Posted

March 3, 2010

Study Start

February 1, 2010

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

December 2, 2013

Results First Posted

September 4, 2013

Record last verified: 2013-10

Locations