Trial Outcomes & Findings for Comparison of 2 Laryngoscopes for Endotracheal Intubation in Children Younger Than 2 Years Old (NCT NCT01488370)
NCT ID: NCT01488370
Last Updated: 2019-03-26
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
65 participants
Primary outcome timeframe
Less than one day, representing the day of surgery and period of endotracheal intubation during induction of general anesthesia
Results posted on
2019-03-26
Participant Flow
Participant milestones
| Measure |
Glidescope
A device for endotracheal intubation.
Endotracheal intubation: Endotracheal intubation
|
Storz
A device for endotracheal intubation.
Endotracheal intubation: Endotracheal intubation
|
Standard Laryngoscope
A device for endotracheal intubation
Endotracheal intubation: Endotracheal intubation
|
|---|---|---|---|
|
Overall Study
STARTED
|
22
|
23
|
20
|
|
Overall Study
COMPLETED
|
22
|
22
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
Glidescope
A device for endotracheal intubation.
Endotracheal intubation: Endotracheal intubation
|
Storz
A device for endotracheal intubation.
Endotracheal intubation: Endotracheal intubation
|
Standard Laryngoscope
A device for endotracheal intubation
Endotracheal intubation: Endotracheal intubation
|
|---|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
1
|
1
|
Baseline Characteristics
Comparison of 2 Laryngoscopes for Endotracheal Intubation in Children Younger Than 2 Years Old
Baseline characteristics by cohort
| Measure |
Glidescope
n=22 Participants
A device for endotracheal intubation.
Endotracheal intubation: Endotracheal intubation
|
Storz
n=22 Participants
A device for endotracheal intubation.
Endotracheal intubation: Endotracheal intubation
|
Standard Laryngoscope
n=19 Participants
A device for endotracheal intubation
Endotracheal intubation: Endotracheal intubation
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
7.6 Months
n=5 Participants
|
8.5 Months
n=7 Participants
|
8.1 Months
n=5 Participants
|
8.1 Months
n=4 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
ASA Status I
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
ASA Status II
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
ASA Status III
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
ASA Status IV
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Weight
|
8.2 Kg
n=5 Participants
|
8.0 Kg
n=7 Participants
|
8.0 Kg
n=5 Participants
|
8.0 Kg
n=4 Participants
|
|
Percentile Weight for Length
|
71.9 Percentile
n=5 Participants
|
58.5 Percentile
n=7 Participants
|
72.1 Percentile
n=5 Participants
|
71.9 Percentile
n=4 Participants
|
PRIMARY outcome
Timeframe: Less than one day, representing the day of surgery and period of endotracheal intubation during induction of general anesthesiaPopulation: Time to successful tracheal intubation
Outcome measures
| Measure |
Glidescope
n=20 Participants
A device for endotracheal intubation.
Endotracheal intubation: Endotracheal intubation
|
Storz
n=21 Participants
A device for endotracheal intubation.
Endotracheal intubation: Endotracheal intubation
|
Standard Laryngoscope
n=19 Participants
A device for endotracheal intubation
Endotracheal intubation: Endotracheal intubation
|
|---|---|---|---|
|
Measurement of Time to Intubation Will Begin at the Time of Mouth Opening and End With the Removal of the Tip of the Laryngoscope Blade From the Patient's Mouth After Successful Endotracheal Intubation.
|
30.8 Seconds
Interval 24.1 to 46.4
|
42.1 Seconds
Interval 34.0 to 59.0
|
21.5 Seconds
Interval 17.0 to 34.3
|
SECONDARY outcome
Timeframe: Less than one day, representing the day of surgery and period of endotracheal intubation during induction of general anesthesia.Other secondary outcome measures will be the use of external laryngeal manipulation to improve glottic view, tissue trauma and type,and method of rescue if initial intubation attempt proves unsuccessful.
Outcome measures
| Measure |
Glidescope
n=22 Participants
A device for endotracheal intubation.
Endotracheal intubation: Endotracheal intubation
|
Storz
n=22 Participants
A device for endotracheal intubation.
Endotracheal intubation: Endotracheal intubation
|
Standard Laryngoscope
n=19 Participants
A device for endotracheal intubation
Endotracheal intubation: Endotracheal intubation
|
|---|---|---|---|
|
Successful Intubation After One Laryngoscopy Attempt
|
17 Participants
|
16 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Less than one day, representing the day of surgery and period of endotracheal intubation during induction of general anesthesia.Outcome measures
| Measure |
Glidescope
n=22 Participants
A device for endotracheal intubation.
Endotracheal intubation: Endotracheal intubation
|
Storz
n=22 Participants
A device for endotracheal intubation.
Endotracheal intubation: Endotracheal intubation
|
Standard Laryngoscope
n=19 Participants
A device for endotracheal intubation
Endotracheal intubation: Endotracheal intubation
|
|---|---|---|---|
|
Successful Intubation After Two Laryngoscopy Attempts
|
3 Participants
|
5 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Less than one day, representing the day of surgery and period of endotracheal intubation during induction of general anesthesia.Outcome measures
| Measure |
Glidescope
n=22 Participants
A device for endotracheal intubation.
Endotracheal intubation: Endotracheal intubation
|
Storz
n=22 Participants
A device for endotracheal intubation.
Endotracheal intubation: Endotracheal intubation
|
Standard Laryngoscope
n=19 Participants
A device for endotracheal intubation
Endotracheal intubation: Endotracheal intubation
|
|---|---|---|---|
|
Successful Intubation After Three Laryngoscopy Attempts
|
1 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Through endotracheal intubation during induction of general anesthesia, an average of 10 minutesOutcome measures
| Measure |
Glidescope
n=22 Participants
A device for endotracheal intubation.
Endotracheal intubation: Endotracheal intubation
|
Storz
n=22 Participants
A device for endotracheal intubation.
Endotracheal intubation: Endotracheal intubation
|
Standard Laryngoscope
n=19 Participants
A device for endotracheal intubation
Endotracheal intubation: Endotracheal intubation
|
|---|---|---|---|
|
Successful Intubation After Four Laryngoscopy Attempts
|
1 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Glidescope
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Storz
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard 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
Elizabeth Ghazal, MD
Loma Linda University Department of Anesthesiology
Phone: 909-558-4475
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place