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Effectiveness of Video System in Improving Learning of Tracheal Intubation Using Standard Laryngoscopy Among Novices

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ClinicalTrials.gov Identifier: NCT01080118
Recruitment Status : Completed
First Posted : March 3, 2010
Results First Posted : September 4, 2013
Last Update Posted : December 2, 2013
Sponsor:
Information provided by (Responsible Party):
Gildasio De Oliveira, Northwestern University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator)
Condition: Intubation Intraesophageal
Interventions: Device: Airtraq
Other: Control group, taught with a standard Macintosh laryngoscope

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Medical students and intern trainees with no prior experience in laryngoscopy on clinical rotation in the Department of Anesthesiology were recruited to participate. Written informed consent was obtained from all the study participants.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Trainees received a structured lecture in airway management followed by training in laryngoscopy skills on a mannequin, and required to demonstrate proficiency. Trainees were then randomly assigned to attempt their first two intubations on different patients using either the optical or rigid laryngoscope with a MacIntosh size 3 blade.

Reporting Groups
  Description
Rigid Laryngoscope Group Medical students or interns attempting intubation with standard size 3 Macintosh laryngoscope
Video Laryngoscope Group Medical students or interns attempting intubation with Airtraq video laryngoscope
Rigid Laryngoscope Patients Patients who were intubated using the rigid laryngoscope by the medical student of intern.
Video Laryngoscope Patients Patients who were intubated using the video laryngoscope by interns or medical student.

Participant Flow:   Overall Study
    Rigid Laryngoscope Group   Video Laryngoscope Group   Rigid Laryngoscope Patients   Video Laryngoscope Patients
STARTED   15   15   30   30 
COMPLETED   15   15   30   30 
NOT COMPLETED   0   0   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The 15 in each group represents the medical student/ interns who are being studied.

Reporting Groups
  Description
Rigid Laryngoscope Group Medical students or interns attempting intubation with standard size 3 Macintosh laryngoscope
Video Laryngoscope Group Medical students or interns attempting intubation with Airtraq video laryngoscope
Total Total of all reporting groups

Baseline Measures
   Rigid Laryngoscope Group   Video Laryngoscope Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 15   15   30 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   15   15   30 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 28  (3)   27.5  (2)   27.75  (2.5) 
Gender 
[Units: Participants]
     
Female   4   3   7 
Male   11   12   23 
Region of Enrollment 
[Units: Participants]
     
United States   15   15   30 


  Outcome Measures

1.  Primary:   Successful Endotracheal Intubation   [ Time Frame: 120 seconds ]

2.  Secondary:   Time to Intubation   [ Time Frame: 120 seconds ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Gildasio DeOliveira
Organization: Northwestern University Feinberg School of Medicine
phone: 312-472-3573
e-mail: g-jr@northwestern.edu



Responsible Party: Gildasio De Oliveira, Northwestern University
ClinicalTrials.gov Identifier: NCT01080118     History of Changes
Other Study ID Numbers: STU00007644
First Submitted: February 26, 2010
First Posted: March 3, 2010
Results First Submitted: March 2, 2012
Results First Posted: September 4, 2013
Last Update Posted: December 2, 2013