Trial Outcomes & Findings for Comparison of Three Laryngoscopes in Difficult Laryngoscopy (NCT NCT02387502)
NCT ID: NCT02387502
Last Updated: 2015-05-04
Results Overview
Time of intubation is defined as the time from passing the device beyond the incisors to the confirmation of endotracheal tube placement by square wave capnograph tracings.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
120 participants
Primary outcome timeframe
up to 10 minutes
Results posted on
2015-05-04
Participant Flow
120 patients were recruited for the study. Recruitment process started in January 2014 and the study ended in December 2014. patients were recruited in the operating rooms of a tertiary care teaching hospital.
30 patients were excluded from the study for not meeting the inclusion criteria.
Participant milestones
| Measure |
Intubation With Macintosh Laryngoscope
After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with Macintosh laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.
Intubation- Macintosh laryngoscope: Difficult intubation was simulated by using rigid neck collar. Then patients were intubated according to the assigned laryngoscopes. In Macintosh group, tip of the laryngoscope blade was placed in the vallecula and epiglottis was lifted. After visualization of the vocal cord, patients were intubated.
|
Intubation With MacCoy Laryngoscope
After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with MacCoy laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.
Intubation- MacCoy laryngoscope: In MacCoy group, tip of the laryngoscope blade was placed in the vallecula and lever was pressed to flex the tip. After visualization of the vocal cord, patients were intubated.
|
Intubation With Airtraq Laryngoscope
After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with Airtraq laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.
Intubation- Airtraq laryngoscope: In Airtraq group, the laryngoscope was loaded with endotracheal tube. Airtraq laryngoscope was inserted through midline and after visualization of image of vocal cord through its eyepiece, endotracheal tube was passed.
|
|---|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
40
|
|
Overall Study
COMPLETED
|
40
|
40
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Three Laryngoscopes in Difficult Laryngoscopy
Baseline characteristics by cohort
| Measure |
Intubation With Macintosh Laryngoscope
n=40 Participants
After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with Macintosh laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.
Intubation- Macintosh laryngoscope: Difficult intubation was simulated by using rigid neck collar. Then patients were intubated according to the assigned laryngoscopes. In Macintosh group, tip of the laryngoscope blade was placed in the vallecula and epiglottis was lifted. After visualization of the vocal cord, patients were intubated.
|
Intubation With MacCoy Laryngoscope
n=40 Participants
After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with MacCoy laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.
Intubation- MacCoy laryngoscope: In MacCoy group, tip of the laryngoscope blade was placed in the vallecula and lever was pressed to flex the tip. After visualization of the vocal cord, patients were intubated.
|
Intubation With Airtraq Laryngoscope
n=40 Participants
After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with Airtraq laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.
Intubation- Airtraq laryngoscope: In Airtraq group, the laryngoscope was loaded with endotracheal tube. Airtraq laryngoscope was inserted through midline and after visualization of image of vocal cord through its eyepiece, endotracheal tube was passed.
|
Total
n=120 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
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
40 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
120 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
39.35 years
STANDARD_DEVIATION 9.92 • n=5 Participants
|
38.82 years
STANDARD_DEVIATION 9.62 • n=7 Participants
|
35.47 years
STANDARD_DEVIATION 10.10 • n=5 Participants
|
37.88 years
STANDARD_DEVIATION 9.88 • n=4 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
75 Participants
n=4 Participants
|
|
Weight
|
58.65 Kg
STANDARD_DEVIATION 6.03 • n=5 Participants
|
58.62 Kg
STANDARD_DEVIATION 6.46 • n=7 Participants
|
57.62 Kg
STANDARD_DEVIATION 5.65 • n=5 Participants
|
58.30 Kg
STANDARD_DEVIATION 6.05 • n=4 Participants
|
|
BMI
|
22.41 kg/m^2
STANDARD_DEVIATION 1.11 • n=5 Participants
|
22.43 kg/m^2
STANDARD_DEVIATION 1.07 • n=7 Participants
|
22.03 kg/m^2
STANDARD_DEVIATION 1.13 • n=5 Participants
|
22.29 kg/m^2
STANDARD_DEVIATION 1.10 • n=4 Participants
|
|
Mallampati grade
|
2 units on a scale
n=5 Participants
|
2 units on a scale
n=7 Participants
|
1 units on a scale
n=5 Participants
|
2 units on a scale
n=4 Participants
|
|
Thyromental distance
|
6.19 cm
STANDARD_DEVIATION 0.40 • n=5 Participants
|
6.16 cm
STANDARD_DEVIATION 0.40 • n=7 Participants
|
6.28 cm
STANDARD_DEVIATION 0.44 • n=5 Participants
|
6.21 cm
STANDARD_DEVIATION 0.41 • n=4 Participants
|
PRIMARY outcome
Timeframe: up to 10 minutesTime of intubation is defined as the time from passing the device beyond the incisors to the confirmation of endotracheal tube placement by square wave capnograph tracings.
Outcome measures
| Measure |
Intubation With Macintosh Laryngoscope
n=40 Participants
After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with Macintosh laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.
Intubation- Macintosh laryngoscope: Difficult intubation was simulated by using rigid neck collar. Then patients were intubated according to the assigned laryngoscopes. In Macintosh group, tip of the laryngoscope blade was placed in the vallecula and epiglottis was lifted. After visualization of the vocal cord, patients were intubated.
|
Intubation With MacCoy Laryngoscope
n=40 Participants
After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with MacCoy laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.
Intubation- MacCoy laryngoscope: In MacCoy group, tip of the laryngoscope blade was placed in the vallecula and lever was pressed to flex the tip. After visualization of the vocal cord, patients were intubated.
|
Intubation With Airtraq Laryngoscope
n=40 Participants
After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with Airtraq laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.
Intubation- Airtraq laryngoscope: In Airtraq group, the laryngoscope was loaded with endotracheal tube. Airtraq laryngoscope was inserted through midline and after visualization of image of vocal cord through its eyepiece, endotracheal tube was passed.
|
|---|---|---|---|
|
Time of Intubation
|
41.22 seconds
Standard Deviation 4.72
|
37.62 seconds
Standard Deviation 3.45
|
27.80 seconds
Standard Deviation 3.87
|
Adverse Events
Intubation With Macintosh Laryngoscope
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Intubation With MacCoy Laryngoscope
Serious events: 5 serious events
Other events: 0 other events
Deaths: 0 deaths
Intubation With Airtraq Laryngoscope
Serious events: 8 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Intubation With Macintosh Laryngoscope
n=40 participants at risk
After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with Macintosh laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.
Intubation- Macintosh laryngoscope: Difficult intubation was simulated by using rigid neck collar. Then patients were intubated according to the assigned laryngoscopes. In Macintosh group, tip of the laryngoscope blade was placed in the vallecula and epiglottis was lifted. After visualization of the vocal cord, patients were intubated.
|
Intubation With MacCoy Laryngoscope
n=40 participants at risk
After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with MacCoy laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.
Intubation- MacCoy laryngoscope: In MacCoy group, tip of the laryngoscope blade was placed in the vallecula and lever was pressed to flex the tip. After visualization of the vocal cord, patients were intubated.
|
Intubation With Airtraq Laryngoscope
n=40 participants at risk
After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with Airtraq laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.
Intubation- Airtraq laryngoscope: In Airtraq group, the laryngoscope was loaded with endotracheal tube. Airtraq laryngoscope was inserted through midline and after visualization of image of vocal cord through its eyepiece, endotracheal tube was passed.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Airway trauma
|
7.5%
3/40 • up to 30 minutes after extubation
|
12.5%
5/40 • up to 30 minutes after extubation
|
20.0%
8/40 • up to 30 minutes after extubation
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place