Trial Outcomes & Findings for Effectiveness of Video System in Improving Learning of Tracheal Intubation Using Standard Laryngoscopy Among Novices (NCT NCT01080118)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

90 participants

Primary outcome timeframe

120 seconds

Results posted on

2013-12-02

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	15	15	30	30
Overall Study COMPLETED	15	15	30	30
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rigid Laryngoscope Group n=15 Participants Medical students or interns attempting intubation with standard size 3 Macintosh laryngoscope	Video Laryngoscope Group n=15 Participants Medical students or interns attempting intubation with Airtraq video laryngoscope	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	28 years STANDARD_DEVIATION 3 • n=5 Participants	27.5 years STANDARD_DEVIATION 2 • n=7 Participants	27.75 years STANDARD_DEVIATION 2.5 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants	15 participants n=7 Participants	30 participants n=5 Participants

PRIMARY outcome

Timeframe: 120 seconds

Population: 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.

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

Outcome measures

Outcome measures
Measure	Rigid Laryngoscope Group n=15 Participants Medical students or interns attempting intubation with standard size 3 Macintosh laryngoscope	Video Laryngoscope Group n=15 Participants Medical students or interns attempting intubation with Airtraq video laryngoscope
Successful Endotracheal Intubation	33.3 % successful	83.3 % successful

SECONDARY outcome

Timeframe: 120 seconds

Population: 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.

Time to intubation is the time interval of blade insertion until the removal of the laryngoscope.

Outcome measures

Outcome measures
Measure	Rigid Laryngoscope Group n=15 Participants Medical students or interns attempting intubation with standard size 3 Macintosh laryngoscope	Video Laryngoscope Group n=15 Participants Medical students or interns attempting intubation with Airtraq video laryngoscope
Time to Intubation	75 seconds Interval 59.0 to 90.0	35 seconds Interval 27.0 to 44.0

Adverse Events

Rigid Laryngoscope Group

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Video Laryngoscope Group

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Rigid Laryngoscope Group n=15 participants at risk Medical students or interns attempting intubation with standard size 3 Macintosh laryngoscope	Video Laryngoscope Group n=15 participants at risk Medical students or interns attempting intubation with Airtraq video laryngoscope
Respiratory, thoracic and mediastinal disorders mucosal laceration	60.0% 9/15 • Number of events 9 • 1 day	6.7% 1/15 • Number of events 1 • 1 day

Additional Information

Dr. Gildasio DeOliveira

Northwestern University Feinberg School of Medicine

Phone: 312-472-3573

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place