Trial Outcomes & Findings for The Videolaryngoscopy in Small Infants (NCT NCT03396432)
NCT ID: NCT03396432
Last Updated: 2021-03-25
Results Overview
comparing the tracheal intubation (TI) first attempt success rate using VL vs. DL
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
566 participants
Primary outcome timeframe
at the time of intubation
Results posted on
2021-03-25
Participant Flow
The study was recruited per protocol without any protocol deviation or violation.
The block size was varying among 2, 4, 6 to avoid the predictability of device assignment. To further balance device assignment, we'll stratify the randomization by study site and clinician's role. Separate randomization schedule was generated for each stratum.
Participant milestones
| Measure |
Video Laryngoscopy for Endotracheal (ET) Placement
Device:
Storz C-MAC Video Laryngoscope
Video Laryngoscopy for ET placement: Tracheal intubation performed with the Storz C-Mac Video Laryngoscope
Direct Laryngoscopy for ET Placement: Tracheal Intubation performed with the Miller Blade
|
Direct Laryngoscopy for ET Placement
Device:
Miller Laryngoscope
Video Laryngoscopy for ET placement: Tracheal intubation performed with the Storz C-Mac Video Laryngoscope
Direct Laryngoscopy for ET Placement: Tracheal Intubation performed with the Miller Blade
|
|---|---|---|
|
Overall Study
STARTED
|
283
|
283
|
|
Overall Study
COMPLETED
|
274
|
277
|
|
Overall Study
NOT COMPLETED
|
9
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Video Laryngoscopy for Endotracheal (ET) Placement
n=274 Participants
Device:
Storz C-MAC Video Laryngoscope
Video Laryngoscopy for ET placement: Tracheal intubation performed with the Storz C-Mac Video Laryngoscope
Direct Laryngoscopy for ET Placement: Tracheal Intubation performed with the Miller Blade
|
Direct Laryngoscopy for ET Placement
n=277 Participants
Device:
Miller Laryngoscope
Video Laryngoscopy for ET placement: Tracheal intubation performed with the Storz C-Mac Video Laryngoscope
Direct Laryngoscopy for ET Placement: Tracheal Intubation performed with the Miller Blade
|
Total
n=551 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
0-30 Days
|
17 Participants
n=274 Participants
|
20 Participants
n=277 Participants
|
37 Participants
n=551 Participants
|
|
Age, Customized
31-90 Days
|
55 Participants
n=274 Participants
|
64 Participants
n=277 Participants
|
119 Participants
n=551 Participants
|
|
Age, Customized
> 90 Days
|
202 Participants
n=274 Participants
|
193 Participants
n=277 Participants
|
395 Participants
n=551 Participants
|
|
Sex: Female, Male
Female
|
79 Participants
n=274 Participants
|
96 Participants
n=277 Participants
|
175 Participants
n=551 Participants
|
|
Sex: Female, Male
Male
|
195 Participants
n=274 Participants
|
181 Participants
n=277 Participants
|
376 Participants
n=551 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Weight (kg)
|
6.5 kg
n=274 Participants
|
6.6 kg
n=277 Participants
|
6.5 kg
n=551 Participants
|
|
ASA
1 - Normal
|
58 Participants
n=274 Participants
|
72 Participants
n=277 Participants
|
130 Participants
n=551 Participants
|
|
ASA
2 - Mild systemic disease
|
133 Participants
n=274 Participants
|
136 Participants
n=277 Participants
|
269 Participants
n=551 Participants
|
|
ASA
>= 2 - Mod - Severe systemic disease
|
83 Participants
n=274 Participants
|
69 Participants
n=277 Participants
|
152 Participants
n=551 Participants
|
|
Induction Technique -IV
|
28 Participants
n=274 Participants
|
39 Participants
n=277 Participants
|
67 Participants
n=551 Participants
|
|
Muscle Relaxant
None
|
15 Participants
n=274 Participants
|
14 Participants
n=277 Participants
|
29 Participants
n=551 Participants
|
|
Muscle Relaxant
Succinylcholine
|
9 Participants
n=274 Participants
|
11 Participants
n=277 Participants
|
20 Participants
n=551 Participants
|
|
Muscle Relaxant
Other
|
250 Participants
n=274 Participants
|
252 Participants
n=277 Participants
|
502 Participants
n=551 Participants
|
|
Device experience as number of infant intubations
0
|
38 Participants
n=274 Participants
|
10 Participants
n=277 Participants
|
48 Participants
n=551 Participants
|
|
Device experience as number of infant intubations
1-10
|
79 Participants
n=274 Participants
|
59 Participants
n=277 Participants
|
138 Participants
n=551 Participants
|
|
Device experience as number of infant intubations
11-20
|
36 Participants
n=274 Participants
|
36 Participants
n=277 Participants
|
72 Participants
n=551 Participants
|
|
Device experience as number of infant intubations
21-50
|
49 Participants
n=274 Participants
|
37 Participants
n=277 Participants
|
86 Participants
n=551 Participants
|
|
Device experience as number of infant intubations
>50
|
62 Participants
n=274 Participants
|
128 Participants
n=277 Participants
|
190 Participants
n=551 Participants
|
|
Device experience as number of infant intubations
Unknown
|
10 Participants
n=274 Participants
|
7 Participants
n=277 Participants
|
17 Participants
n=551 Participants
|
|
Provider Role
Anes Attending
|
69 Participants
n=274 Participants
|
69 Participants
n=277 Participants
|
138 Participants
n=551 Participants
|
|
Provider Role
Anes Fellow
|
99 Participants
n=274 Participants
|
102 Participants
n=277 Participants
|
201 Participants
n=551 Participants
|
|
Provider Role
Anes Resident
|
106 Participants
n=274 Participants
|
106 Participants
n=277 Participants
|
212 Participants
n=551 Participants
|
PRIMARY outcome
Timeframe: at the time of intubationcomparing the tracheal intubation (TI) first attempt success rate using VL vs. DL
Outcome measures
| Measure |
Video Laryngoscopy for Endotracheal (ET) Placement
n=274 Participants
Device:
Storz C-MAC Video Laryngoscope
Video Laryngoscopy for ET placement: Tracheal intubation performed with the Storz C-Mac Video Laryngoscope
Direct Laryngoscopy for ET Placement: Tracheal Intubation performed with the Miller Blade
|
Direct Laryngoscopy for ET Placement
n=277 Participants
Device:
Miller Laryngoscope
Video Laryngoscopy for ET placement: Tracheal intubation performed with the Storz C-Mac Video Laryngoscope
Direct Laryngoscopy for ET Placement: Tracheal Intubation performed with the Miller Blade
|
|---|---|---|
|
Number of Participants With Success in the First Attempt
|
253 Participants
|
243 Participants
|
SECONDARY outcome
Timeframe: At the time of intubationComparing the lowest oxygen saturation during tracheal intubation with VL vs. DL
Outcome measures
| Measure |
Video Laryngoscopy for Endotracheal (ET) Placement
n=274 Participants
Device:
Storz C-MAC Video Laryngoscope
Video Laryngoscopy for ET placement: Tracheal intubation performed with the Storz C-Mac Video Laryngoscope
Direct Laryngoscopy for ET Placement: Tracheal Intubation performed with the Miller Blade
|
Direct Laryngoscopy for ET Placement
n=277 Participants
Device:
Miller Laryngoscope
Video Laryngoscopy for ET placement: Tracheal intubation performed with the Storz C-Mac Video Laryngoscope
Direct Laryngoscopy for ET Placement: Tracheal Intubation performed with the Miller Blade
|
|---|---|---|
|
Hypoxia
|
9 Participants
|
15 Participants
|
Adverse Events
Video Laryngoscopy for Endotracheal (ET) Placement
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Direct Laryngoscopy for ET Placement
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Video Laryngoscopy for Endotracheal (ET) Placement
n=274 participants at risk
Device:
Storz C-MAC Video Laryngoscope
Video Laryngoscopy for ET placement: Tracheal intubation performed with the Storz C-Mac Video Laryngoscope
|
Direct Laryngoscopy for ET Placement
n=277 participants at risk
Device:
Miller Laryngoscope
Direct Laryngoscopy for ET Placement: Tracheal Intubation performed with the Miller Blade
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
0.00%
0/274 • Upon discharge from PACU or up to 24 hr after intubation
|
0.36%
1/277 • Number of events 1 • Upon discharge from PACU or up to 24 hr after intubation
|
|
Cardiac disorders
Intermittent tachypnea
|
0.36%
1/274 • Number of events 1 • Upon discharge from PACU or up to 24 hr after intubation
|
0.00%
0/277 • Upon discharge from PACU or up to 24 hr after intubation
|
|
Respiratory, thoracic and mediastinal disorders
Brief Desaturation
|
0.73%
2/274 • Number of events 3 • Upon discharge from PACU or up to 24 hr after intubation
|
0.36%
1/277 • Number of events 1 • Upon discharge from PACU or up to 24 hr after intubation
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place