Trial Outcomes & Findings for Comparison of Miller's Blade and Airtraq Laryngoscope in Children (NCT NCT02423317)
NCT ID: NCT02423317
Last Updated: 2016-03-09
Results Overview
It is defined as the time from placement of Airtraq or Miller laryngoscope into the mouth till appearance of the capnograph waveform
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
5 minutes
Results posted on
2016-03-09
Participant Flow
Participant milestones
| Measure |
Intubation With Miller's Blade
After induction and muscle paralysis, Miller's blade was introduced in the patient's mouth. After visualization of vocal cord, patient was intubated with appropriate sized tracheal tube.
Intubation with Miller's blade: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Miller's blade.
|
Intubation With Airtraq Laryngoscope
After induction and muscle paralysis, Airtraq laryngoscope's blade was introduced in the patient's mouth. After visualization of vocal cord as a reflected image in the viewfinder of the device, patient was intubated with appropriate sized tracheal tube.
Intubation with Airtraq: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Airtraq.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Miller's Blade and Airtraq Laryngoscope in Children
Baseline characteristics by cohort
| Measure |
Intubation With Miller's Blade
n=30 Participants
After induction and muscle paralysis, Miller's blade was introduced in the patient's mouth. After visualization of vocal cord, patient was intubated with appropriate sized tracheal tube.
Intubation with Miller's blade: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Miller's blade.
|
Intubation With Airtraq Laryngoscope
n=30 Participants
After induction and muscle paralysis, Airtraq laryngoscope's blade was introduced in the patient's mouth. After visualization of vocal cord as a reflected image in the viewfinder of the device, patient was intubated with appropriate sized tracheal tube.
Intubation with Airtraq: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Airtraq.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
5.4 years
STANDARD_DEVIATION 1.78 • n=5 Participants
|
6.15 years
STANDARD_DEVIATION 2.64 • n=7 Participants
|
5.775 years
STANDARD_DEVIATION 2.21 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Weight
|
15.9 Kg
STANDARD_DEVIATION 2.53 • n=5 Participants
|
16.5 Kg
STANDARD_DEVIATION 3.87 • n=7 Participants
|
16.2 Kg
STANDARD_DEVIATION 3.2 • n=5 Participants
|
PRIMARY outcome
Timeframe: 5 minutesIt is defined as the time from placement of Airtraq or Miller laryngoscope into the mouth till appearance of the capnograph waveform
Outcome measures
| Measure |
Intubation With Miller's Blade
n=30 Participants
After induction and muscle paralysis, Miller's blade was introduced in the patient's mouth. After visualization of vocal cord, patient was intubated with appropriate sized tracheal tube.
Intubation with Miller's blade: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Miller's blade.
|
Intubation With Airtraq Laryngoscope
n=30 Participants
After induction and muscle paralysis, Airtraq laryngoscope's blade was introduced in the patient's mouth. After visualization of vocal cord as a reflected image in the viewfinder of the device, patient was intubated with appropriate sized tracheal tube.
Intubation with Airtraq: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Airtraq.
|
|---|---|---|
|
Time to Intubation
|
15.13 seconds
Standard Deviation 1.33
|
11.53 seconds
Standard Deviation 0.49
|
SECONDARY outcome
Timeframe: 5 minutesA single insertion of the Airtraq or a single insertion of the Miller laryngoscope blade into the mouth with passing the endotracheal tube beyond the glottis was considered as an attempt.
Outcome measures
| Measure |
Intubation With Miller's Blade
n=30 Participants
After induction and muscle paralysis, Miller's blade was introduced in the patient's mouth. After visualization of vocal cord, patient was intubated with appropriate sized tracheal tube.
Intubation with Miller's blade: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Miller's blade.
|
Intubation With Airtraq Laryngoscope
n=30 Participants
After induction and muscle paralysis, Airtraq laryngoscope's blade was introduced in the patient's mouth. After visualization of vocal cord as a reflected image in the viewfinder of the device, patient was intubated with appropriate sized tracheal tube.
Intubation with Airtraq: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Airtraq.
|
|---|---|---|
|
Number of Intubation in First Attempts;
|
25 Intubations
|
29 Intubations
|
SECONDARY outcome
Timeframe: 5 minutesThe intubating anaesthesiologist graded the ease of intubation for both techniques on a visual analogue scale from 1 to 10, 10 being most difficult or failed intubation and 1 being very easy intubation.
Outcome measures
| Measure |
Intubation With Miller's Blade
n=30 Participants
After induction and muscle paralysis, Miller's blade was introduced in the patient's mouth. After visualization of vocal cord, patient was intubated with appropriate sized tracheal tube.
Intubation with Miller's blade: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Miller's blade.
|
Intubation With Airtraq Laryngoscope
n=30 Participants
After induction and muscle paralysis, Airtraq laryngoscope's blade was introduced in the patient's mouth. After visualization of vocal cord as a reflected image in the viewfinder of the device, patient was intubated with appropriate sized tracheal tube.
Intubation with Airtraq: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Airtraq.
|
|---|---|---|
|
Ease of Intubation.
|
5 scores on visual analogue scale
Interval 3.75 to 6.0
|
3 scores on visual analogue scale
Interval 2.0 to 3.25
|
SECONDARY outcome
Timeframe: 5 minutesThe Percentage of glottic opening score represents the percentage of glottic opening seen, defined by the linear span from the anterior commissure to the interarytenoid notch
Outcome measures
| Measure |
Intubation With Miller's Blade
n=30 Participants
After induction and muscle paralysis, Miller's blade was introduced in the patient's mouth. After visualization of vocal cord, patient was intubated with appropriate sized tracheal tube.
Intubation with Miller's blade: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Miller's blade.
|
Intubation With Airtraq Laryngoscope
n=30 Participants
After induction and muscle paralysis, Airtraq laryngoscope's blade was introduced in the patient's mouth. After visualization of vocal cord as a reflected image in the viewfinder of the device, patient was intubated with appropriate sized tracheal tube.
Intubation with Airtraq: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Airtraq.
|
|---|---|---|
|
Percentage of Glottic Opening Scoring.
|
75 percentage of glottic opening
Interval 66.0 to 100.0
|
100 percentage of glottic opening
Interval 93.0 to 100.0
|
SECONDARY outcome
Timeframe: 5 minutesIt is the number of participants who were successfully intubated after first, second or third attempts. Success of intubation is defined as placement of endotracheal tube inside the trachea, confirmed by bilateral chest auscultation and square wave capnograph tracing.
Outcome measures
| Measure |
Intubation With Miller's Blade
n=30 Participants
After induction and muscle paralysis, Miller's blade was introduced in the patient's mouth. After visualization of vocal cord, patient was intubated with appropriate sized tracheal tube.
Intubation with Miller's blade: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Miller's blade.
|
Intubation With Airtraq Laryngoscope
n=30 Participants
After induction and muscle paralysis, Airtraq laryngoscope's blade was introduced in the patient's mouth. After visualization of vocal cord as a reflected image in the viewfinder of the device, patient was intubated with appropriate sized tracheal tube.
Intubation with Airtraq: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Airtraq.
|
|---|---|---|
|
Overall Intubation Success Rate.
|
30 participants
|
30 participants
|
SECONDARY outcome
Timeframe: 5 minutesInsertion of tracheal tube inside the esophagus
Outcome measures
| Measure |
Intubation With Miller's Blade
n=30 Participants
After induction and muscle paralysis, Miller's blade was introduced in the patient's mouth. After visualization of vocal cord, patient was intubated with appropriate sized tracheal tube.
Intubation with Miller's blade: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Miller's blade.
|
Intubation With Airtraq Laryngoscope
n=30 Participants
After induction and muscle paralysis, Airtraq laryngoscope's blade was introduced in the patient's mouth. After visualization of vocal cord as a reflected image in the viewfinder of the device, patient was intubated with appropriate sized tracheal tube.
Intubation with Airtraq: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Airtraq.
|
|---|---|---|
|
Number of Esophageal Intubation.
|
4 esophageal intubation
|
0 esophageal intubation
|
SECONDARY outcome
Timeframe: 5 minutesAirway trauma was defined as blood detected on the blades of laryngoscopes, blood on endotracheal tube after extubation or tongue-lip-dental trauma.
Outcome measures
| Measure |
Intubation With Miller's Blade
n=30 Participants
After induction and muscle paralysis, Miller's blade was introduced in the patient's mouth. After visualization of vocal cord, patient was intubated with appropriate sized tracheal tube.
Intubation with Miller's blade: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Miller's blade.
|
Intubation With Airtraq Laryngoscope
n=30 Participants
After induction and muscle paralysis, Airtraq laryngoscope's blade was introduced in the patient's mouth. After visualization of vocal cord as a reflected image in the viewfinder of the device, patient was intubated with appropriate sized tracheal tube.
Intubation with Airtraq: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Airtraq.
|
|---|---|---|
|
Number of Participants With Airway Trauma
|
3 participants
|
1 participants
|
Adverse Events
Intubation With Miller's Blade
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intubation With Airtraq Laryngoscope
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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
Restriction type: LTE60