Trial Outcomes & Findings for Endotracheal Intubation Using Videolaryngoscopy Versus Conventional Direct Laryngoscopy (NCT NCT04701762)
NCT ID: NCT04701762
Last Updated: 2024-09-19
Results Overview
Intubation attempts is defined as introduction and subsequent removal of a laryngoscope blade into the oral cavity whether or not the trachea was intubated.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
7736 participants
Primary outcome timeframe
From the start time of intubation to time of the end of surgery up to 24 hours.
Results posted on
2024-09-19
Participant Flow
The Protocol Enrollment (N = 7,736) is 172 less than the calculated total number of participants Started (N = 7908), because these patients were enrolled more than once and assigned to different clusters due to having multiple operations in designated operating rooms during the study.
Unit of analysis: surgical procedures
Participant milestones
| Measure |
Cluster 1: Operating Suites 60 to 70
A cluster randomized multiple crossover design was used for this trial.
The cardiac surgical suite was divided into 2 sets of 11 operating rooms each (cluster 1: operating suites 60 to 70, and cluster 2: operating suites 71 to 81). These sets are the clusters. All operations performed in these operating suites were assessed for eligibility. N= 172 patients were enrolled more than once and assigned to different clusters due to having multiple operations.
Each week, one set of ORs was randomly assigned to video laryngoscopy, while the other set was assigned to direct laryngoscopy. At the beginning of each week, the randomization occurred again, so in the following week, the set of ORs that had video laryngoscopy might now be assigned to direct laryngoscopy, and vice versa. This randomization continues for 90 weeks, with each set of ORs potentially receiving a different intervention each week.
For analysis, each operating room within a set was considered a separate cluster. Randomization was conducted weekly on a 1:1 unstratified basis, using computer-generated codes maintained in a web-based system. Investigators accessed these codes a day before each new treatment block began.
N=1,945 patients with 1,995 operations were enrolled into cluster 1 during the 42 direct laryngoscopy periods (Randomization occurs weekly for 90 weeks). Additionally, 2,418 patients with 2,486 operations were enrolled in cluster 1 during the 48 video laryngoscopy periods.
|
Cluster 2: Operating Suites 71 to 81
A total of 1,916 patients with 2,021 operations were enrolled into cluster 2 during the 48 direct laryngoscopy periods (Randomization occurs weekly for 90 weeks). Additionally, 1,828 patients with 1,927 operations were enrolled into cluster 2 during the 42 video laryngoscopy periods (Randomization occurs weekly for 90 weeks).
In patients randomized to videolaryngoscopy, initial intubation was performed using GlideScope videolaryngoscope. GlideScope videolaryngoscope (Verathon, Bothell, WA 98011): After confirming adequate muscle relaxation, initial laryngoscopy will be performed using GlideScope videolaryngoscope with an appropriately sized blade (usually size 3 or 4). The GlideScope (Verathon, Bothell, WA 98011) is an FDA-cleared commercially available portable videolaryngoscope.
|
|---|---|---|
|
Overall Study
STARTED
|
4301 4481
|
3607 3948
|
|
Overall Study
Direct Laryngoscopy
|
1945 1995
|
1916 2021
|
|
Overall Study
Videolaryngoscopy
|
2418 2486
|
1828 1927
|
|
Overall Study
COMPLETED
|
4301 4481
|
3607 3948
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
One missing in each group
Baseline characteristics by cohort
| Measure |
Videolaryngoscopy
n=4413 surgical procedure
Initial intubation performed using GlideScope videolaryngoscope.
GlideScope videolaryngoscope (Verathon, Bothell, WA 98011): After confirming adequate muscle relaxation, initial laryngoscopy will be performed using GlideScope videolaryngoscope with an appropriately sized blade (usually size 3 or 4). The GlideScope (Verathon, Bothell, WA 98011) is an FDA-cleared commercially available portable videolaryngoscope.
|
Conventional Direct Laryngoscopy
n=4016 surgical procedure
Initial intubation performed using direct laryngoscopy.
Direct laryngoscopy: After confirming adequate muscle relaxation, initial laryngoscopy will be performed using direct laryngoscopy with an appropriately sized Macintosh or Miller blade (usually size 3 or 4);
|
Total
n=8429 surgical procedure
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63 years
STANDARD_DEVIATION 13 • n=4413 surgical procedure
|
63 years
STANDARD_DEVIATION 14 • n=4016 surgical procedure
|
63 years
STANDARD_DEVIATION 14 • n=8429 surgical procedure
|
|
Sex: Female, Male
Female
|
2880 surgical procedure
n=4413 surgical procedure
|
2599 surgical procedure
n=4016 surgical procedure
|
5479 surgical procedure
n=8429 surgical procedure
|
|
Sex: Female, Male
Male
|
1533 surgical procedure
n=4413 surgical procedure
|
1417 surgical procedure
n=4016 surgical procedure
|
2950 surgical procedure
n=8429 surgical procedure
|
|
Race/Ethnicity, Customized
White/Caucasian
|
3655 surgical procedure
n=4413 surgical procedure
|
3293 surgical procedure
n=4016 surgical procedure
|
6948 surgical procedure
n=8429 surgical procedure
|
|
Race/Ethnicity, Customized
Black
|
411 surgical procedure
n=4413 surgical procedure
|
410 surgical procedure
n=4016 surgical procedure
|
821 surgical procedure
n=8429 surgical procedure
|
|
Race/Ethnicity, Customized
Other
|
171 surgical procedure
n=4413 surgical procedure
|
167 surgical procedure
n=4016 surgical procedure
|
338 surgical procedure
n=8429 surgical procedure
|
|
Race/Ethnicity, Customized
Missing
|
176 surgical procedure
n=4413 surgical procedure
|
146 surgical procedure
n=4016 surgical procedure
|
322 surgical procedure
n=8429 surgical procedure
|
|
BMI
|
29 kg/m2
STANDARD_DEVIATION 6.5 • n=4412 surgical procedure • One missing in each group
|
28 kg/m2
STANDARD_DEVIATION 6.0 • n=4015 surgical procedure • One missing in each group
|
28 kg/m2
STANDARD_DEVIATION 6.5 • n=8427 surgical procedure • One missing in each group
|
|
Admission category
Elective
|
3711 surgical procedure
n=4413 surgical procedure
|
3424 surgical procedure
n=4016 surgical procedure
|
7135 surgical procedure
n=8429 surgical procedure
|
|
Admission category
Emergent
|
702 surgical procedure
n=4413 surgical procedure
|
592 surgical procedure
n=4016 surgical procedure
|
1294 surgical procedure
n=8429 surgical procedure
|
|
Surgery type
Cardiac
|
3317 surgical procedure
n=4413 surgical procedure
|
2934 surgical procedure
n=4016 surgical procedure
|
6251 surgical procedure
n=8429 surgical procedure
|
|
Surgery type
Vascular
|
559 surgical procedure
n=4413 surgical procedure
|
560 surgical procedure
n=4016 surgical procedure
|
1119 surgical procedure
n=8429 surgical procedure
|
|
Surgery type
Other
|
474 surgical procedure
n=4413 surgical procedure
|
453 surgical procedure
n=4016 surgical procedure
|
927 surgical procedure
n=8429 surgical procedure
|
|
Surgery type
Thoracic
|
63 surgical procedure
n=4413 surgical procedure
|
69 surgical procedure
n=4016 surgical procedure
|
132 surgical procedure
n=8429 surgical procedure
|
|
ASA (American Society of Anesthesiologists) physical status
1 (Healthy)
|
6 surgical procedure
n=4413 surgical procedure
|
14 surgical procedure
n=4016 surgical procedure
|
20 surgical procedure
n=8429 surgical procedure
|
|
ASA (American Society of Anesthesiologists) physical status
2 (Mild systemic illness)
|
74 surgical procedure
n=4413 surgical procedure
|
94 surgical procedure
n=4016 surgical procedure
|
168 surgical procedure
n=8429 surgical procedure
|
|
ASA (American Society of Anesthesiologists) physical status
3 (Severe systemic illness)
|
694 surgical procedure
n=4413 surgical procedure
|
668 surgical procedure
n=4016 surgical procedure
|
1362 surgical procedure
n=8429 surgical procedure
|
|
ASA (American Society of Anesthesiologists) physical status
4 (Life-threatening systemic illness)
|
3605 surgical procedure
n=4413 surgical procedure
|
3211 surgical procedure
n=4016 surgical procedure
|
6816 surgical procedure
n=8429 surgical procedure
|
|
ASA (American Society of Anesthesiologists) physical status
5 (Not expected to survive without the operation)
|
34 surgical procedure
n=4413 surgical procedure
|
29 surgical procedure
n=4016 surgical procedure
|
63 surgical procedure
n=8429 surgical procedure
|
|
Level of first intubation clinician
CRNA
|
1672 surgical procedure
n=4413 surgical procedure
|
1611 surgical procedure
n=4016 surgical procedure
|
3283 surgical procedure
n=8429 surgical procedure
|
|
Level of first intubation clinician
Resident
|
1357 surgical procedure
n=4413 surgical procedure
|
1157 surgical procedure
n=4016 surgical procedure
|
2514 surgical procedure
n=8429 surgical procedure
|
|
Level of first intubation clinician
Fellow
|
603 surgical procedure
n=4413 surgical procedure
|
582 surgical procedure
n=4016 surgical procedure
|
1185 surgical procedure
n=8429 surgical procedure
|
|
Level of first intubation clinician
SRNA
|
639 surgical procedure
n=4413 surgical procedure
|
536 surgical procedure
n=4016 surgical procedure
|
1175 surgical procedure
n=8429 surgical procedure
|
|
Level of first intubation clinician
Attending anesthesiologist
|
113 surgical procedure
n=4413 surgical procedure
|
112 surgical procedure
n=4016 surgical procedure
|
225 surgical procedure
n=8429 surgical procedure
|
|
Level of first intubation clinician
Medical student
|
29 surgical procedure
n=4413 surgical procedure
|
18 surgical procedure
n=4016 surgical procedure
|
47 surgical procedure
n=8429 surgical procedure
|
|
Mallampati score
I (Soft palate, uvula, pillars visible)
|
1078 surgical procedure
n=4413 surgical procedure
|
1109 surgical procedure
n=4016 surgical procedure
|
2187 surgical procedure
n=8429 surgical procedure
|
|
Mallampati score
II (Soft palate, major part of uvula visible)
|
2583 surgical procedure
n=4413 surgical procedure
|
2406 surgical procedure
n=4016 surgical procedure
|
4989 surgical procedure
n=8429 surgical procedure
|
|
Mallampati score
III (Soft palate, base of uvula visible)
|
660 surgical procedure
n=4413 surgical procedure
|
453 surgical procedure
n=4016 surgical procedure
|
1113 surgical procedure
n=8429 surgical procedure
|
|
Mallampati score
IV (Only hard palate visible)
|
64 surgical procedure
n=4413 surgical procedure
|
24 surgical procedure
n=4016 surgical procedure
|
88 surgical procedure
n=8429 surgical procedure
|
|
Mallampati score
Missing
|
28 surgical procedure
n=4413 surgical procedure
|
24 surgical procedure
n=4016 surgical procedure
|
52 surgical procedure
n=8429 surgical procedure
|
|
History of difficult intubation within past 5 years
|
138 surgical procedure
n=4413 surgical procedure
|
112 surgical procedure
n=4016 surgical procedure
|
250 surgical procedure
n=8429 surgical procedure
|
PRIMARY outcome
Timeframe: From the start time of intubation to time of the end of surgery up to 24 hours.Intubation attempts is defined as introduction and subsequent removal of a laryngoscope blade into the oral cavity whether or not the trachea was intubated.
Outcome measures
| Measure |
Videolaryngoscopy
n=4413 Surgical procedures
Initial intubation performed using GlideScope videolaryngoscope.
GlideScope videolaryngoscope (Verathon, Bothell, WA 98011): After confirming adequate muscle relaxation, initial laryngoscopy will be performed using GlideScope videolaryngoscope with an appropriately sized blade (usually size 3 or 4). The GlideScope (Verathon, Bothell, WA 98011) is an FDA-cleared commercially available portable videolaryngoscope.
|
Conventional Direct Laryngoscopy
n=4016 Surgical procedures
Initial intubation performed using direct laryngoscopy.
Direct laryngoscopy: After confirming adequate muscle relaxation, initial laryngoscopy will be performed using direct laryngoscopy with an appropriately sized Macintosh or Miller blade (usually size 3 or 4);
|
|---|---|---|
|
The Number of Intubation Attempts With the Initial Laryngoscopy Instrument.
1
|
4336 Surgical procedures
|
3710 Surgical procedures
|
|
The Number of Intubation Attempts With the Initial Laryngoscopy Instrument.
2
|
70 Surgical procedures
|
277 Surgical procedures
|
|
The Number of Intubation Attempts With the Initial Laryngoscopy Instrument.
3
|
3 Surgical procedures
|
27 Surgical procedures
|
|
The Number of Intubation Attempts With the Initial Laryngoscopy Instrument.
>3
|
4 Surgical procedures
|
2 Surgical procedures
|
SECONDARY outcome
Timeframe: From the start time of intubation to time of the end of surgery.Intubation failure is defined by the responsible clinician switching to an alternative laryngoscopy device for any reason at any time, or by more than 3 intubation attempts.
Outcome measures
| Measure |
Videolaryngoscopy
n=4413 Surgical procedures
Initial intubation performed using GlideScope videolaryngoscope.
GlideScope videolaryngoscope (Verathon, Bothell, WA 98011): After confirming adequate muscle relaxation, initial laryngoscopy will be performed using GlideScope videolaryngoscope with an appropriately sized blade (usually size 3 or 4). The GlideScope (Verathon, Bothell, WA 98011) is an FDA-cleared commercially available portable videolaryngoscope.
|
Conventional Direct Laryngoscopy
n=4016 Surgical procedures
Initial intubation performed using direct laryngoscopy.
Direct laryngoscopy: After confirming adequate muscle relaxation, initial laryngoscopy will be performed using direct laryngoscopy with an appropriately sized Macintosh or Miller blade (usually size 3 or 4);
|
|---|---|---|
|
Intubation Failure
|
12 Surgical procedures
|
161 Surgical procedures
|
SECONDARY outcome
Timeframe: From the start time of intubation to time of the end of surgery.Airway injury is defined as any bleeding or apparent injury to the lips, mouth, pharynx, vocal cords, or other airway structures recorded by the anesthesia team. Dental injury is defined as any apparent injury to the teeth as recorded by the anesthesia team.
Outcome measures
| Measure |
Videolaryngoscopy
n=4413 Surgical procedures
Initial intubation performed using GlideScope videolaryngoscope.
GlideScope videolaryngoscope (Verathon, Bothell, WA 98011): After confirming adequate muscle relaxation, initial laryngoscopy will be performed using GlideScope videolaryngoscope with an appropriately sized blade (usually size 3 or 4). The GlideScope (Verathon, Bothell, WA 98011) is an FDA-cleared commercially available portable videolaryngoscope.
|
Conventional Direct Laryngoscopy
n=4016 Surgical procedures
Initial intubation performed using direct laryngoscopy.
Direct laryngoscopy: After confirming adequate muscle relaxation, initial laryngoscopy will be performed using direct laryngoscopy with an appropriately sized Macintosh or Miller blade (usually size 3 or 4);
|
|---|---|---|
|
Any Dental or Airway Injury
|
41 Surgical procedures
|
42 Surgical procedures
|
OTHER_PRE_SPECIFIED outcome
Timeframe: In five minutes after intubation.Population: N = 64 surgical procedures had missing MAP in the Videolaryngoscopy group; N = 39 procedures had missing MAP in the Direct laryngoscopy group.
Maximum mean arterial pressure (MAP) in the five minutes after intubation
Outcome measures
| Measure |
Videolaryngoscopy
n=4349 Surgical procedures
Initial intubation performed using GlideScope videolaryngoscope.
GlideScope videolaryngoscope (Verathon, Bothell, WA 98011): After confirming adequate muscle relaxation, initial laryngoscopy will be performed using GlideScope videolaryngoscope with an appropriately sized blade (usually size 3 or 4). The GlideScope (Verathon, Bothell, WA 98011) is an FDA-cleared commercially available portable videolaryngoscope.
|
Conventional Direct Laryngoscopy
n=3977 Surgical procedures
Initial intubation performed using direct laryngoscopy.
Direct laryngoscopy: After confirming adequate muscle relaxation, initial laryngoscopy will be performed using direct laryngoscopy with an appropriately sized Macintosh or Miller blade (usually size 3 or 4);
|
|---|---|---|
|
Maximum Mean Arterial Pressure
|
107 mmHg
Standard Deviation 24
|
105 mmHg
Standard Deviation 24
|
OTHER_PRE_SPECIFIED outcome
Timeframe: In five minutes after intubationPopulation: N = 26 procedures had missing HR in Videolaryngoscopy group; N = 17 procedures had missing HR in Direct laryngoscopy group.
Maximum heart rate in the five minutes after intubation
Outcome measures
| Measure |
Videolaryngoscopy
n=4387 Surgical procedures
Initial intubation performed using GlideScope videolaryngoscope.
GlideScope videolaryngoscope (Verathon, Bothell, WA 98011): After confirming adequate muscle relaxation, initial laryngoscopy will be performed using GlideScope videolaryngoscope with an appropriately sized blade (usually size 3 or 4). The GlideScope (Verathon, Bothell, WA 98011) is an FDA-cleared commercially available portable videolaryngoscope.
|
Conventional Direct Laryngoscopy
n=3999 Surgical procedures
Initial intubation performed using direct laryngoscopy.
Direct laryngoscopy: After confirming adequate muscle relaxation, initial laryngoscopy will be performed using direct laryngoscopy with an appropriately sized Macintosh or Miller blade (usually size 3 or 4);
|
|---|---|---|
|
Maximum Heart Rate (HR)
|
83 beats/min
Standard Deviation 18
|
83 beats/min
Standard Deviation 18
|
Adverse Events
Videolaryngoscopy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Conventional 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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place