Trial Outcomes & Findings for Initial Experience With Storz C-MAC Video Intubation System (NCT NCT01104090)
NCT ID: NCT01104090
Last Updated: 2021-11-01
Results Overview
Time taken for successful placement of endotracheal tube (that is, intubation).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
at the time of intubation (about 10 seconds)
Results posted on
2021-11-01
Participant Flow
Participant milestones
| Measure |
C-MAC Direct Laryngoscopy, Then C-MAC Indirect Laryngoscopy
Each patient received both direct laryngoscopy and indirect laryngoscopy, and the order of receipt was randomized. Patients were intubated once, and intubation occurred after the second laryngoscopy.
|
C-MAC Indirect Laryngoscopy, Then C-MAC Direct Laryngoscopy
Each patient received both direct laryngoscopy and indirect laryngoscopy, and the order of receipt was randomized. Patients were intubated once, and intubation occurred after the second laryngoscopy.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
25
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Initial Experience With Storz C-MAC Video Intubation System
Baseline characteristics by cohort
| Measure |
C-MAC Direct Laryngoscopy, Then C-MAC Indirect Laryngoscopy
n=25 Participants
Each patient received both direct laryngoscopy and indirect laryngoscopy, and the order of receipt was randomized. Patients were intubated once, and intubation occurred after the second laryngoscopy.
|
C-MAC Indirect Laryngoscopy, Then C-MAC Direct Laryngoscopy
n=25 Participants
Each patient received both direct laryngoscopy and indirect laryngoscopy, and the order of receipt was randomized. Patients were intubated once, and intubation occurred after the second laryngoscopy.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.2 years
STANDARD_DEVIATION 14.2 • n=5 Participants
|
49.1 years
STANDARD_DEVIATION 15.2 • n=7 Participants
|
47.7 years
STANDARD_DEVIATION 14.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at the time of intubation (about 10 seconds)Time taken for successful placement of endotracheal tube (that is, intubation).
Outcome measures
| Measure |
C-MAC Direct Laryngoscopy, Then C-MAC Indirect Laryngoscopy
n=25 Participants
Each patient received both direct laryngoscopy and indirect laryngoscopy, and the order of receipt was randomized. Patients were intubated once, and intubation occurred after the second laryngoscopy.
|
C-MAC Indirect Laryngoscopy, Then C-MAC Direct Laryngoscopy
n=25 Participants
Each patient received both direct laryngoscopy and indirect laryngoscopy, and the order of receipt was randomized. Patients were intubated once, and intubation occurred after the second laryngoscopy.
|
|---|---|---|
|
Time for Intubation
|
12.3 seconds
Standard Deviation 11.1
|
9.8 seconds
Standard Deviation 7.1
|
SECONDARY outcome
Timeframe: at the time of laryngoscopy (about 10 seconds)Laryngoscopy time is defined as the time between advancing the laryngoscopy and obtaining the optimal view of the airway.
Outcome measures
| Measure |
C-MAC Direct Laryngoscopy, Then C-MAC Indirect Laryngoscopy
n=25 Participants
Each patient received both direct laryngoscopy and indirect laryngoscopy, and the order of receipt was randomized. Patients were intubated once, and intubation occurred after the second laryngoscopy.
|
C-MAC Indirect Laryngoscopy, Then C-MAC Direct Laryngoscopy
n=25 Participants
Each patient received both direct laryngoscopy and indirect laryngoscopy, and the order of receipt was randomized. Patients were intubated once, and intubation occurred after the second laryngoscopy.
|
|---|---|---|
|
Laryngoscopy Time
first laryngoscopy
|
8.7 seconds
Standard Deviation 4.7
|
14.1 seconds
Standard Deviation 12.1
|
|
Laryngoscopy Time
second laryngoscopy
|
9.1 seconds
Standard Deviation 6.1
|
12.2 seconds
Standard Deviation 7.5
|
SECONDARY outcome
Timeframe: at the time of laryngoscopy (about 10 seconds)Modified Cormack-Lehane classification: 1. Full view of glottis 2. a Partial view of glottis 2b Only posterior extremity of glottis seen or only arytenoid cartilages 3 Only epiglottis seen, none of glottis seen 4 Neither glottis nor epiglottis seen
Outcome measures
| Measure |
C-MAC Direct Laryngoscopy, Then C-MAC Indirect Laryngoscopy
n=25 Participants
Each patient received both direct laryngoscopy and indirect laryngoscopy, and the order of receipt was randomized. Patients were intubated once, and intubation occurred after the second laryngoscopy.
|
C-MAC Indirect Laryngoscopy, Then C-MAC Direct Laryngoscopy
n=25 Participants
Each patient received both direct laryngoscopy and indirect laryngoscopy, and the order of receipt was randomized. Patients were intubated once, and intubation occurred after the second laryngoscopy.
|
|---|---|---|
|
Airway View at the Time of Laryngoscopy as Categorized by the Modified Cormack-Lehane Classification (Before External Manipulation)
second laryngoscopy · 2b
|
1 Participants
|
5 Participants
|
|
Airway View at the Time of Laryngoscopy as Categorized by the Modified Cormack-Lehane Classification (Before External Manipulation)
second laryngoscopy · 3
|
0 Participants
|
3 Participants
|
|
Airway View at the Time of Laryngoscopy as Categorized by the Modified Cormack-Lehane Classification (Before External Manipulation)
first laryngoscopy · 1
|
12 Participants
|
19 Participants
|
|
Airway View at the Time of Laryngoscopy as Categorized by the Modified Cormack-Lehane Classification (Before External Manipulation)
first laryngoscopy · 2a
|
7 Participants
|
3 Participants
|
|
Airway View at the Time of Laryngoscopy as Categorized by the Modified Cormack-Lehane Classification (Before External Manipulation)
first laryngoscopy · 2b
|
6 Participants
|
1 Participants
|
|
Airway View at the Time of Laryngoscopy as Categorized by the Modified Cormack-Lehane Classification (Before External Manipulation)
first laryngoscopy · 3
|
0 Participants
|
2 Participants
|
|
Airway View at the Time of Laryngoscopy as Categorized by the Modified Cormack-Lehane Classification (Before External Manipulation)
first laryngoscopy · 4
|
0 Participants
|
0 Participants
|
|
Airway View at the Time of Laryngoscopy as Categorized by the Modified Cormack-Lehane Classification (Before External Manipulation)
second laryngoscopy · 1
|
20 Participants
|
11 Participants
|
|
Airway View at the Time of Laryngoscopy as Categorized by the Modified Cormack-Lehane Classification (Before External Manipulation)
second laryngoscopy · 2a
|
4 Participants
|
6 Participants
|
|
Airway View at the Time of Laryngoscopy as Categorized by the Modified Cormack-Lehane Classification (Before External Manipulation)
second laryngoscopy · 4
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: at the time of laryngoscopy (about 10 seconds)Modified Cormack-Lehane classification: 1. Full view of glottis 2. a Partial view of glottis 2b Only posterior extremity of glottis seen or only arytenoid cartilages 3 Only epiglottis seen, none of glottis seen 4 Neither glottis nor epiglottis seen
Outcome measures
| Measure |
C-MAC Direct Laryngoscopy, Then C-MAC Indirect Laryngoscopy
n=25 Participants
Each patient received both direct laryngoscopy and indirect laryngoscopy, and the order of receipt was randomized. Patients were intubated once, and intubation occurred after the second laryngoscopy.
|
C-MAC Indirect Laryngoscopy, Then C-MAC Direct Laryngoscopy
n=25 Participants
Each patient received both direct laryngoscopy and indirect laryngoscopy, and the order of receipt was randomized. Patients were intubated once, and intubation occurred after the second laryngoscopy.
|
|---|---|---|
|
Airway View at the Time of Laryngoscopy as Categorized by the Modified Cormack-Lehane Classification (After External Manipulation)
first laryngoscopy · 1
|
15 Participants
|
20 Participants
|
|
Airway View at the Time of Laryngoscopy as Categorized by the Modified Cormack-Lehane Classification (After External Manipulation)
first laryngoscopy · 2a
|
10 Participants
|
4 Participants
|
|
Airway View at the Time of Laryngoscopy as Categorized by the Modified Cormack-Lehane Classification (After External Manipulation)
first laryngoscopy · 2b
|
0 Participants
|
1 Participants
|
|
Airway View at the Time of Laryngoscopy as Categorized by the Modified Cormack-Lehane Classification (After External Manipulation)
first laryngoscopy · 3
|
0 Participants
|
0 Participants
|
|
Airway View at the Time of Laryngoscopy as Categorized by the Modified Cormack-Lehane Classification (After External Manipulation)
first laryngoscopy · 4
|
0 Participants
|
0 Participants
|
|
Airway View at the Time of Laryngoscopy as Categorized by the Modified Cormack-Lehane Classification (After External Manipulation)
second laryngoscopy · 1
|
22 Participants
|
12 Participants
|
|
Airway View at the Time of Laryngoscopy as Categorized by the Modified Cormack-Lehane Classification (After External Manipulation)
second laryngoscopy · 2a
|
3 Participants
|
11 Participants
|
|
Airway View at the Time of Laryngoscopy as Categorized by the Modified Cormack-Lehane Classification (After External Manipulation)
second laryngoscopy · 2b
|
0 Participants
|
2 Participants
|
|
Airway View at the Time of Laryngoscopy as Categorized by the Modified Cormack-Lehane Classification (After External Manipulation)
second laryngoscopy · 3
|
0 Participants
|
0 Participants
|
|
Airway View at the Time of Laryngoscopy as Categorized by the Modified Cormack-Lehane Classification (After External Manipulation)
second laryngoscopy · 4
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: at the time of intubation (about 10 seconds)Outcome measures
| Measure |
C-MAC Direct Laryngoscopy, Then C-MAC Indirect Laryngoscopy
n=25 Participants
Each patient received both direct laryngoscopy and indirect laryngoscopy, and the order of receipt was randomized. Patients were intubated once, and intubation occurred after the second laryngoscopy.
|
C-MAC Indirect Laryngoscopy, Then C-MAC Direct Laryngoscopy
n=25 Participants
Each patient received both direct laryngoscopy and indirect laryngoscopy, and the order of receipt was randomized. Patients were intubated once, and intubation occurred after the second laryngoscopy.
|
|---|---|---|
|
Number of Participants With Successful Intubation
|
25 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: at the time of intubation (about 10 seconds)Ease of intubation as assessed by a rating scale, which ranged from 1 (very easy) to 5 (very difficult).
Outcome measures
| Measure |
C-MAC Direct Laryngoscopy, Then C-MAC Indirect Laryngoscopy
n=25 Participants
Each patient received both direct laryngoscopy and indirect laryngoscopy, and the order of receipt was randomized. Patients were intubated once, and intubation occurred after the second laryngoscopy.
|
C-MAC Indirect Laryngoscopy, Then C-MAC Direct Laryngoscopy
n=25 Participants
Each patient received both direct laryngoscopy and indirect laryngoscopy, and the order of receipt was randomized. Patients were intubated once, and intubation occurred after the second laryngoscopy.
|
|---|---|---|
|
Ease of Intubation as Assessed by a Rating Scale
1
|
14 Participants
|
16 Participants
|
|
Ease of Intubation as Assessed by a Rating Scale
2
|
6 Participants
|
4 Participants
|
|
Ease of Intubation as Assessed by a Rating Scale
3
|
4 Participants
|
4 Participants
|
|
Ease of Intubation as Assessed by a Rating Scale
4
|
1 Participants
|
1 Participants
|
|
Ease of Intubation as Assessed by a Rating Scale
5
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: at the time of laryngoscopy (about 10 seconds)Ease of laryngoscopy as assessed by a rating scale, which ranged from 1 (very easy) to 5 (very difficult).
Outcome measures
| Measure |
C-MAC Direct Laryngoscopy, Then C-MAC Indirect Laryngoscopy
n=25 Participants
Each patient received both direct laryngoscopy and indirect laryngoscopy, and the order of receipt was randomized. Patients were intubated once, and intubation occurred after the second laryngoscopy.
|
C-MAC Indirect Laryngoscopy, Then C-MAC Direct Laryngoscopy
n=25 Participants
Each patient received both direct laryngoscopy and indirect laryngoscopy, and the order of receipt was randomized. Patients were intubated once, and intubation occurred after the second laryngoscopy.
|
|---|---|---|
|
Ease of Laryngoscopy as Assessed by a Rating Scale
3
|
4 Participants
|
5 Participants
|
|
Ease of Laryngoscopy as Assessed by a Rating Scale
1
|
15 Participants
|
13 Participants
|
|
Ease of Laryngoscopy as Assessed by a Rating Scale
2
|
5 Participants
|
4 Participants
|
|
Ease of Laryngoscopy as Assessed by a Rating Scale
4
|
1 Participants
|
3 Participants
|
|
Ease of Laryngoscopy as Assessed by a Rating Scale
5
|
0 Participants
|
0 Participants
|
Adverse Events
C-MAC Direct Laryngoscopy, Then C-MAC Indirect Laryngoscopy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
C-MAC Indirect Laryngoscopy, Then C-MAC Direct Laryngoscopy
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
Davide Cattano, MD, PhD
The University of Texas Health Science Center at Houston
Phone: (713) 500-6200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place