Trial Outcomes & Findings for GlideScope Video Laryngoscope Versus Fiberoptic Intubation (NCT NCT01091948)
NCT ID: NCT01091948
Last Updated: 2016-12-20
Results Overview
Time from insertion of either the GlideScope or in the case of fibreoptic intubation, a Williams airway (SunMed, Largo, FL, USA) into the mouth, to the time when end-tidal PCO2 exceeded 2.7 kPa (20 mmHg).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
75 participants
Primary outcome timeframe
from start of intubation to successfully intubated up to 100 seconds
Results posted on
2016-12-20
Participant Flow
Participant milestones
| Measure |
Active Comparator: Fiberoptic Intubation
Subjects will be intubated with the Fiberoptic laryngoscope.
Active Comparator: GlideScope® Video Laryngoscope Subjects will be intubated with the GlideScope® Video Laryngoscope
|
GlideScope® Video Laryngoscope
Subjects will be intubated with the GlideScope® Video Laryngoscope.
GlideScope® Video Laryngoscope: Patients will be intubated with the GlideScope® Video Laryngoscope.
|
|---|---|---|
|
Overall Study
STARTED
|
37
|
38
|
|
Overall Study
COMPLETED
|
37
|
38
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
GlideScope Video Laryngoscope Versus Fiberoptic Intubation
Baseline characteristics by cohort
| Measure |
Fiberoptic Intubation
n=37 Participants
Subjects will be intubated with the Fiberoptic laryngoscope.
Intubation with Fiberoptic laryngoscope: Subjects will be intubated with the Fiberoptic laryngoscope.
|
GlideScope® Video Laryngoscope
n=38 Participants
Subjects will be intubated with the GlideScope® Video Laryngoscope.
GlideScope® Video Laryngoscope: Patients will be intubated with the GlideScope® Video Laryngoscope.
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54 years
STANDARD_DEVIATION 11 • n=5 Participants
|
52 years
STANDARD_DEVIATION 16 • n=7 Participants
|
53 years
STANDARD_DEVIATION 13 • n=5 Participants
|
|
Gender
Female
|
18 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Gender
Male
|
19 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
36 participants
n=5 Participants
|
33 participants
n=7 Participants
|
69 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Others
|
1 participants
n=5 Participants
|
5 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
37 participants
n=5 Participants
|
38 participants
n=7 Participants
|
75 participants
n=5 Participants
|
|
Weight
|
117 Kg
n=5 Participants
|
104 Kg
n=7 Participants
|
110 Kg
n=5 Participants
|
|
Height
|
171 cm
STANDARD_DEVIATION 12 • n=5 Participants
|
167 cm
STANDARD_DEVIATION 10 • n=7 Participants
|
169 cm
STANDARD_DEVIATION 11 • n=5 Participants
|
|
Body mass index
|
37 kg/m^2
n=5 Participants
|
36 kg/m^2
n=7 Participants
|
37 kg/m^2
n=5 Participants
|
|
ASA physical status
I: A normal healthy patient
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
ASA physical status
II: A patient with mild systemic disease
|
21 participants
n=5 Participants
|
18 participants
n=7 Participants
|
39 participants
n=5 Participants
|
|
ASA physical status
III: A patient with severe systemic disease
|
15 participants
n=5 Participants
|
17 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Modified Mallampati classification
I: Soft palate, uvula, fauces, pillars visible.
|
7 participants
n=5 Participants
|
8 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Modified Mallampati classification
II: Soft palate, uvula, fauces visible.
|
19 participants
n=5 Participants
|
19 participants
n=7 Participants
|
38 participants
n=5 Participants
|
|
Modified Mallampati classification
III: Soft palate, base of uvula visible.
|
10 participants
n=5 Participants
|
8 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Modified Mallampati classification
IV: Only hard palate visible.
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: from start of intubation to successfully intubated up to 100 secondsTime from insertion of either the GlideScope or in the case of fibreoptic intubation, a Williams airway (SunMed, Largo, FL, USA) into the mouth, to the time when end-tidal PCO2 exceeded 2.7 kPa (20 mmHg).
Outcome measures
| Measure |
Active Comparator: Fiberoptic Intubation
n=37 Participants
Subjects will be intubated with the Fiberoptic laryngoscope.
|
GlideScope® Video Laryngoscope
n=38 Participants
Patients will be intubated with the GlideScope® Video Laryngoscope.
|
|---|---|---|
|
Time to Intubation (TTI) as Measured in Seconds
|
43 seconds
Interval 35.0 to 58.0
|
37 seconds
Interval 25.0 to 48.0
|
SECONDARY outcome
Timeframe: from start of intubation to successfully intubatedIntubation difficulty score is a 100-mm-long visual analogue scale (100 mm = extremely difficult);
Outcome measures
| Measure |
Active Comparator: Fiberoptic Intubation
n=37 Participants
Subjects will be intubated with the Fiberoptic laryngoscope.
|
GlideScope® Video Laryngoscope
n=38 Participants
Patients will be intubated with the GlideScope® Video Laryngoscope.
|
|---|---|---|
|
Intubation Difficulty Score
|
20 units on a scale
Interval 11.0 to 40.0
|
15 units on a scale
Interval 10.0 to 21.0
|
SECONDARY outcome
Timeframe: from start of first intubation to end of first intubation attemptOutcome measures
| Measure |
Active Comparator: Fiberoptic Intubation
n=37 Participants
Subjects will be intubated with the Fiberoptic laryngoscope.
|
GlideScope® Video Laryngoscope
n=38 Participants
Patients will be intubated with the GlideScope® Video Laryngoscope.
|
|---|---|---|
|
Successful Intubation on 1st Attempt
|
31 participants
|
36 participants
|
SECONDARY outcome
Timeframe: at 1 min prior to intubation, intubation, and 2, 4, 6, 8, and 10 min afterArterial oxygen saturation was recorded at 1 min prior to intubation, intubation, and 2, 4, 6, 8, and 10 min after; hypoxaemia was defined as occurrence of arterial oxygen saturation \<90% at any of the above measurements.
Outcome measures
| Measure |
Active Comparator: Fiberoptic Intubation
n=37 Participants
Subjects will be intubated with the Fiberoptic laryngoscope.
|
GlideScope® Video Laryngoscope
n=38 Participants
Patients will be intubated with the GlideScope® Video Laryngoscope.
|
|---|---|---|
|
Occurrence of Hypoxaemia
|
2 participants
|
4 participants
|
SECONDARY outcome
Timeframe: Right after intubationTrace bleeding is a binary outcome: yes or no, which is determined based on amount of post-intubation bleeding present in the suction tube
Outcome measures
| Measure |
Active Comparator: Fiberoptic Intubation
n=37 Participants
Subjects will be intubated with the Fiberoptic laryngoscope.
|
GlideScope® Video Laryngoscope
n=38 Participants
Patients will be intubated with the GlideScope® Video Laryngoscope.
|
|---|---|---|
|
Trace Bleeding
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: On the first postoperative dayPopulation: This outcome was not collected for 1 patient in each group.
Outcome measures
| Measure |
Active Comparator: Fiberoptic Intubation
n=36 Participants
Subjects will be intubated with the Fiberoptic laryngoscope.
|
GlideScope® Video Laryngoscope
n=37 Participants
Patients will be intubated with the GlideScope® Video Laryngoscope.
|
|---|---|---|
|
Sore Throat Grade
None
|
19 participants
|
21 participants
|
|
Sore Throat Grade
Mild
|
14 participants
|
11 participants
|
|
Sore Throat Grade
Moderate
|
2 participants
|
3 participants
|
|
Sore Throat Grade
Severe
|
1 participants
|
2 participants
|
SECONDARY outcome
Timeframe: from start of intubation to successfully intubatedOutcome measures
| Measure |
Active Comparator: Fiberoptic Intubation
n=37 Participants
Subjects will be intubated with the Fiberoptic laryngoscope.
|
GlideScope® Video Laryngoscope
n=38 Participants
Patients will be intubated with the GlideScope® Video Laryngoscope.
|
|---|---|---|
|
Number of Intubation Attempts
1
|
31 participants
|
36 participants
|
|
Number of Intubation Attempts
2
|
3 participants
|
1 participants
|
|
Number of Intubation Attempts
3
|
2 participants
|
0 participants
|
|
Number of Intubation Attempts
4
|
1 participants
|
1 participants
|
Adverse Events
Fiberoptic
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
GlideScope® Video 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