Trial Outcomes & Findings for Effectiveness and Safety of the Levitan Scope for Laryngoscopy and Tracheal Intubation With a Simulated Difficult Airway (NCT NCT01491984)
NCT ID: NCT01491984
Last Updated: 2015-03-10
Results Overview
The anesthesiologist graded the laryngeal view after induction of anesthesia using Cormack-Lehane Scale. Grade 1 = full view of glottis Grade 2a = partial view of glottis Grade 2b = Only posterior extremity of glottis seen or only arytenoid cartilages Grade 3 = Only epiglottis seen, none of glottis seen Grade 4 = Neither glottis nor epiglottis seen
COMPLETED
PHASE4
105 participants
intraoperative
2015-03-10
Participant Flow
From July 29,2009 to March 12, 2010 we recruited women aged 16-75 yrs old, ASA class I-II, and undergoing elective gynecologic surgery at the IWK Health Centre under general anesthesia with planned orotracheal intubation.
105 participants were consented and randomized, and of those 11 were withdrawn for either anticipated difficult airway, decreased SpO2, or unavailable staff/equipment. A total of 94 participants started the study protocol. 3 were withdrawn. 91 participants completed the study protocol.
Participant milestones
| Measure |
Levitan FPS/Mac Laryngoscope Intubation Order
Intubation with Levitan
laryngoscopy view with Levitan :
|
Macintosh/Levitan FPS Laryngoscope Intubation Order
traditional MAC intubation
laryngoscopy view with MAC :
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
45
|
|
Overall Study
COMPLETED
|
47
|
44
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effectiveness and Safety of the Levitan Scope for Laryngoscopy and Tracheal Intubation With a Simulated Difficult Airway
Baseline characteristics by cohort
| Measure |
Intubation Order Levitan/MAC
n=49 Participants
The LFS is used to guide and confirm endotracheal placement of endotracheal tubes during routine laryngoscopy.
|
Intubation Order MAC/Levitan
n=45 Participants
A size 7.0-mm endotracheal tube with a malleable stylet was used to facilitate Macintosh intubation (standard practice).
|
Total
n=94 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
45 years
STANDARD_DEVIATION 13 • n=99 Participants
|
45 years
STANDARD_DEVIATION 13 • n=107 Participants
|
45 years
STANDARD_DEVIATION 13 • n=206 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=99 Participants
|
45 Participants
n=107 Participants
|
94 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: intraoperativeThe anesthesiologist graded the laryngeal view after induction of anesthesia using Cormack-Lehane Scale. Grade 1 = full view of glottis Grade 2a = partial view of glottis Grade 2b = Only posterior extremity of glottis seen or only arytenoid cartilages Grade 3 = Only epiglottis seen, none of glottis seen Grade 4 = Neither glottis nor epiglottis seen
Outcome measures
| Measure |
Levitan/MAC Intubation
n=91 Participants
Laryngoscopy with Levitan, then MAC
|
MAC/Levitan Intubation
n=94 Participants
Laryngoscopy with MAC then Levitan
|
|---|---|---|
|
Cormack-Lehane Grade
Good Laryngoscopic View-Cormack-Lehane grade 1 & 2
|
58 participants
|
53 participants
|
|
Cormack-Lehane Grade
Poor Laryngoscopic View-Cormack-Lehane grade 3 & 4
|
33 participants
|
41 participants
|
SECONDARY outcome
Timeframe: intraoperativeNumber of intubation attempts was recorded after intubation was completed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: intraoperativeThe attending anesthesiologist rated the difficulty in using each technique to intubate the larynx using an 11-point numeric rating scale and a 4-point visual rating scale.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: intraoperativeTime to successful intubation was documented during the second laryngoscopy and defined as the time from the insertion of the Macintosh laryngoscope into the oral cavity to its removal.
Outcome measures
Outcome data not reported
Adverse Events
Levitan FPS Intubation
Macintosh Intubation
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place