ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Enrollment 90
Recruitment Details 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 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.
Arm/Group Title Rigid Laryngoscope Group Video Laryngoscope Group Rigid Laryngoscope Patients Video Laryngoscope Patients
Hide Arm/Group Description Medical students or interns attempting intubation with standard size 3 Macintosh laryngoscope Medical students or interns attempting intubation with Airtraq video laryngoscope Patients who were intubated using the rigid laryngoscope by the medical student of intern. Patients who were intubated using the video laryngoscope by interns or medical student.
Period Title: Overall Study
Started 15 15 30 30
Completed 15 15 30 30
Not Completed 0 0 0 0
Arm/Group Title Rigid Laryngoscope Group Video Laryngoscope Group Total
Hide Arm/Group Description Medical students or interns attempting intubation with standard size 3 Macintosh laryngoscope Medical students or interns attempting intubation with Airtraq video laryngoscope Total of all reporting groups
Overall Number of Baseline Participants 15 15 30
Hide Baseline Analysis Population Description
The 15 in each group represents the medical student/ interns who are being studied.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
15
 100.0%
15
 100.0%
30
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 15 participants 30 participants
28  (3) 27.5  (2) 27.75  (2.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
Female
4
  26.7%
3
  20.0%
7
  23.3%
Male
11
  73.3%
12
  80.0%
23
  76.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants 15 participants 30 participants
15 15 30
1.Primary Outcome
Title Successful Endotracheal Intubation
Hide Description A successful placement of the endotracheal tube as defined by the presence of bilateral breath sounds and positive recording of end tidal carbon dioxide.
Time Frame 120 seconds
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The sample analysis was all of the medical students or interns who consented to participate in this study. All participants data was used for the analysis.
Arm/Group Title Rigid Laryngoscope Group Video Laryngoscope Group
Hide Arm/Group Description:
Medical students or interns attempting intubation with standard size 3 Macintosh laryngoscope
Medical students or interns attempting intubation with Airtraq video laryngoscope
Overall Number of Participants Analyzed 15 15
Measure Type: Number
Unit of Measure: % successful
33.3 83.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rigid Laryngoscope Group, Video Laryngoscope Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio, log
Estimated Value .05
Confidence Interval (2-Sided) 99%
.05 to .05
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Rigid Laryngoscope Group, Video Laryngoscope Group
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Equivalence
Statistical Test of Hypothesis P-Value .001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Time to Intubation
Hide Description Time to intubation is the time interval of blade insertion until the removal of the laryngoscope.
Time Frame 120 seconds
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The sample analysis was all of the medical students or interns who consented to participate in this study. All participants data was used for the analysis.
Arm/Group Title Rigid Laryngoscope Group Video Laryngoscope Group
Hide Arm/Group Description:
Medical students or interns attempting intubation with standard size 3 Macintosh laryngoscope
Medical students or interns attempting intubation with Airtraq video laryngoscope
Overall Number of Participants Analyzed 15 15
Mean (95% Confidence Interval)
Unit of Measure: seconds
75
(59 to 90)
35
(27 to 44)
Time Frame 1 day
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Rigid Laryngoscope Group Video Laryngoscope Group
Hide Arm/Group Description Medical students or interns attempting intubation with standard size 3 Macintosh laryngoscope Medical students or interns attempting intubation with Airtraq video laryngoscope
All-Cause Mortality
Rigid Laryngoscope Group Video Laryngoscope Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Rigid Laryngoscope Group Video Laryngoscope Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/15 (0.00%)      0/15 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Rigid Laryngoscope Group Video Laryngoscope Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/15 (60.00%)      1/15 (6.67%)    
Respiratory, thoracic and mediastinal disorders     
mucosal laceration  1 [1]  9/15 (60.00%)  9 1/15 (6.67%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, mucosal laceration
[1]
Oral mucosa lacerated with introduction of device.
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.
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
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