Trial Outcomes & Findings for Comparison of 3 Direct Laryngoscopes for Tracheal Intubation in Patients Undergoing Lumbar Spine Surgery (NCT NCT02955511)
NCT ID: NCT02955511
Last Updated: 2022-10-19
Results Overview
Intubation Time: It is the time taken to intubate: from the initial insertion of the laryngoscope blade to the placement of the tracheal tube (approximately 3 minutes). An intubation attempt: It is defined as the insertion of the laryngoscope blade into a patient's mouth, with the objective of inserting an endotracheal tube into the trachea.
TERMINATED
NA
5 participants
up to 3 minutes
2022-10-19
Participant Flow
Participant milestones
| Measure |
Blade MAC Size 3
Patient will be intubated using a:
Direct Laryngoscope (DL) Mac size 3 (Sun-Med GreenLine®/D™ Macintosh)
Blade MAC size 3: Patient will be intubated using the DL- Blade MAC size 3
|
Blade MAC Size 3.5
Patient will be intubated using a:
DL-blade mac size 3.5 (Sun-Med Greenline®/D™ Macintosh)
Blade MAC size 3.5: Patient will be intubated using the DL- Blade MAC size 3.5
|
Inscope Blade Size 3.5
Patient will be intubated using a:
Inscope DL-blade size 3.5
Inscope Blade size 3.5: Patient will be intubated using the Inscope Blade size 3.5
|
|---|---|---|---|
|
Overall Study
STARTED
|
1
|
3
|
1
|
|
Overall Study
COMPLETED
|
1
|
3
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Measure Description: The study terminated early and did not have sufficient enrollment (only five total) into an arm of the study to produce any meaningful results.
Baseline characteristics by cohort
| Measure |
Blade MAC Size 3
n=1 Participants
Patient will be intubated using a:
Direct Laryngoscope (DL) Mac size 3 (Sun-Med GreenLine®/D™ Macintosh)
Blade MAC size 3: Patient will be intubated using the DL- Blade MAC size 3
|
Blade MAC Size 3.5
n=3 Participants
Patient will be intubated using a:
DL-blade mac size 3.5 (Sun-Med Greenline®/D™ Macintosh)
Blade MAC size 3.5: Patient will be intubated using the DL- Blade MAC size 3.5
|
Inscope Blade Size 3.5
n=1 Participants
Patient will be intubated using a:
Inscope DL-blade size 3.5
Inscope Blade size 3.5: Patient will be intubated using the Inscope Blade size 3.5
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
50 to 64 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Age, Customized
65 to < 75 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Age, Customized
>= 75 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants • Measure Description: The study terminated early and did not have sufficient enrollment (only five total) into an arm of the study to produce any meaningful results.
|
0 Participants
n=7 Participants • Measure Description: The study terminated early and did not have sufficient enrollment (only five total) into an arm of the study to produce any meaningful results.
|
0 Participants
n=5 Participants • Measure Description: The study terminated early and did not have sufficient enrollment (only five total) into an arm of the study to produce any meaningful results.
|
0 Participants
n=4 Participants • Measure Description: The study terminated early and did not have sufficient enrollment (only five total) into an arm of the study to produce any meaningful results.
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants • Measure Description: The study terminated early and did not have sufficient enrollment (only five total) into an arm of the study to produce any meaningful results.
|
0 Participants
n=7 Participants • Measure Description: The study terminated early and did not have sufficient enrollment (only five total) into an arm of the study to produce any meaningful results.
|
0 Participants
n=5 Participants • Measure Description: The study terminated early and did not have sufficient enrollment (only five total) into an arm of the study to produce any meaningful results.
|
1 Participants
n=4 Participants • Measure Description: The study terminated early and did not have sufficient enrollment (only five total) into an arm of the study to produce any meaningful results.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants • Measure Description: The study terminated early and did not have sufficient enrollment (only five total) into an arm of the study to produce any meaningful results.
|
0 Participants
n=7 Participants • Measure Description: The study terminated early and did not have sufficient enrollment (only five total) into an arm of the study to produce any meaningful results.
|
0 Participants
n=5 Participants • Measure Description: The study terminated early and did not have sufficient enrollment (only five total) into an arm of the study to produce any meaningful results.
|
0 Participants
n=4 Participants • Measure Description: The study terminated early and did not have sufficient enrollment (only five total) into an arm of the study to produce any meaningful results.
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants • Measure Description: The study terminated early and did not have sufficient enrollment (only five total) into an arm of the study to produce any meaningful results.
|
0 Participants
n=7 Participants • Measure Description: The study terminated early and did not have sufficient enrollment (only five total) into an arm of the study to produce any meaningful results.
|
0 Participants
n=5 Participants • Measure Description: The study terminated early and did not have sufficient enrollment (only five total) into an arm of the study to produce any meaningful results.
|
0 Participants
n=4 Participants • Measure Description: The study terminated early and did not have sufficient enrollment (only five total) into an arm of the study to produce any meaningful results.
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants • Measure Description: The study terminated early and did not have sufficient enrollment (only five total) into an arm of the study to produce any meaningful results.
|
3 Participants
n=7 Participants • Measure Description: The study terminated early and did not have sufficient enrollment (only five total) into an arm of the study to produce any meaningful results.
|
1 Participants
n=5 Participants • Measure Description: The study terminated early and did not have sufficient enrollment (only five total) into an arm of the study to produce any meaningful results.
|
4 Participants
n=4 Participants • Measure Description: The study terminated early and did not have sufficient enrollment (only five total) into an arm of the study to produce any meaningful results.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants • Measure Description: The study terminated early and did not have sufficient enrollment (only five total) into an arm of the study to produce any meaningful results.
|
0 Participants
n=7 Participants • Measure Description: The study terminated early and did not have sufficient enrollment (only five total) into an arm of the study to produce any meaningful results.
|
0 Participants
n=5 Participants • Measure Description: The study terminated early and did not have sufficient enrollment (only five total) into an arm of the study to produce any meaningful results.
|
0 Participants
n=4 Participants • Measure Description: The study terminated early and did not have sufficient enrollment (only five total) into an arm of the study to produce any meaningful results.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants • Measure Description: The study terminated early and did not have sufficient enrollment (only five total) into an arm of the study to produce any meaningful results.
|
0 Participants
n=7 Participants • Measure Description: The study terminated early and did not have sufficient enrollment (only five total) into an arm of the study to produce any meaningful results.
|
0 Participants
n=5 Participants • Measure Description: The study terminated early and did not have sufficient enrollment (only five total) into an arm of the study to produce any meaningful results.
|
0 Participants
n=4 Participants • Measure Description: The study terminated early and did not have sufficient enrollment (only five total) into an arm of the study to produce any meaningful results.
|
|
Region of Enrollment
United States
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: up to 3 minutesPopulation: Measure Description: The study was terminated early, only FIVE (5) subjects total were enrolled for the three arms groups. It is impossible to produce meaningful results having only five subjects enrolled.
Intubation Time: It is the time taken to intubate: from the initial insertion of the laryngoscope blade to the placement of the tracheal tube (approximately 3 minutes). An intubation attempt: It is defined as the insertion of the laryngoscope blade into a patient's mouth, with the objective of inserting an endotracheal tube into the trachea.
Outcome measures
| Measure |
Blade MAC Size 3
n=1 Participants
Patient will be intubated using a:
Direct Laryngoscope (DL) Mac size 3 (Sun-Med GreenLine®/D™ Macintosh)
Blade MAC size 3: Patient will be intubated using the DL- Blade MAC size 3
|
Blade MAC Size 3.5
n=3 Participants
Patient will be intubated using a:
DL-blade mac size 3.5 (Sun-Med Greenline®/D™ Macintosh)
Blade MAC size 3.5: Patient will be intubated using the DL- Blade MAC size 3.5
|
Inscope Blade Size 3.5
n=1 Participants
Patient will be intubated using a:
Inscope DL-blade size 3.5
Inscope Blade size 3.5: Patient will be intubated using the Inscope Blade size 3.5
|
|---|---|---|---|
|
Intubation Time (Using a Stopwatch)
|
38 Seconds
Standard Deviation 0
|
15.3 Seconds
Standard Deviation 2
|
17 Seconds
Standard Deviation 0
|
PRIMARY outcome
Timeframe: During intubation procedure, up to 1 minutePopulation: Measure Description: The study was terminated early, only FIVE (5) subjects total were enrolled for the three arms groups. It is impossible to produce meaningful results having only five subjects enrolled.
The percentage of the glottis visualized (POGO) score It represents the percentage of glottic opening seen; the score ranges from 0% when none of the glottis is seen to 100% when the entire glottis, including the anterior commissure, is seen.
Outcome measures
| Measure |
Blade MAC Size 3
n=1 Participants
Patient will be intubated using a:
Direct Laryngoscope (DL) Mac size 3 (Sun-Med GreenLine®/D™ Macintosh)
Blade MAC size 3: Patient will be intubated using the DL- Blade MAC size 3
|
Blade MAC Size 3.5
n=3 Participants
Patient will be intubated using a:
DL-blade mac size 3.5 (Sun-Med Greenline®/D™ Macintosh)
Blade MAC size 3.5: Patient will be intubated using the DL- Blade MAC size 3.5
|
Inscope Blade Size 3.5
n=1 Participants
Patient will be intubated using a:
Inscope DL-blade size 3.5
Inscope Blade size 3.5: Patient will be intubated using the Inscope Blade size 3.5
|
|---|---|---|---|
|
Glottis Visualization POGO Score
|
75 percentage of glottic opening
Standard Deviation 0
|
96.6 percentage of glottic opening
Standard Deviation 4
|
80 percentage of glottic opening
Standard Deviation 0
|
PRIMARY outcome
Timeframe: During intubation procedure, up to 3 minutesPopulation: Measure Description: The study was terminated early, only FIVE (5) subjects total were enrolled for the three arms groups. It is impossible to produce meaningful results having only five subjects enrolled.
The time following the initial insertion of the laryngoscope blade into the mouth to confirm w/ CO2 waveform
Outcome measures
| Measure |
Blade MAC Size 3
n=1 Participants
Patient will be intubated using a:
Direct Laryngoscope (DL) Mac size 3 (Sun-Med GreenLine®/D™ Macintosh)
Blade MAC size 3: Patient will be intubated using the DL- Blade MAC size 3
|
Blade MAC Size 3.5
n=3 Participants
Patient will be intubated using a:
DL-blade mac size 3.5 (Sun-Med Greenline®/D™ Macintosh)
Blade MAC size 3.5: Patient will be intubated using the DL- Blade MAC size 3.5
|
Inscope Blade Size 3.5
n=1 Participants
Patient will be intubated using a:
Inscope DL-blade size 3.5
Inscope Blade size 3.5: Patient will be intubated using the Inscope Blade size 3.5
|
|---|---|---|---|
|
Time From the Insertion of the Laryngoscope Blade to Confirm w/ CO2 Waveform
|
49 Seconds
Standard Deviation 0
|
36.5 Seconds
Standard Deviation 12
|
26 Seconds
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 3 minutesPopulation: Measure Description: The study was terminated early, only FIVE (5) subjects total were enrolled for the three arms groups. It is impossible to produce meaningful results having only five subjects enrolled.
An intubation attempt is defined as the insertion of the laryngoscope blade into a patient's mouth, with the objective of inserting an endotracheal tube into the trachea. The number of intubation attempts in each participant for successful tracheal intubation measured how many times the anesthesiologist attempted to place the tube into the trachea of each patient.
Outcome measures
| Measure |
Blade MAC Size 3
n=1 Participants
Patient will be intubated using a:
Direct Laryngoscope (DL) Mac size 3 (Sun-Med GreenLine®/D™ Macintosh)
Blade MAC size 3: Patient will be intubated using the DL- Blade MAC size 3
|
Blade MAC Size 3.5
n=3 Participants
Patient will be intubated using a:
DL-blade mac size 3.5 (Sun-Med Greenline®/D™ Macintosh)
Blade MAC size 3.5: Patient will be intubated using the DL- Blade MAC size 3.5
|
Inscope Blade Size 3.5
n=1 Participants
Patient will be intubated using a:
Inscope DL-blade size 3.5
Inscope Blade size 3.5: Patient will be intubated using the Inscope Blade size 3.5
|
|---|---|---|---|
|
Intubation Attempts
|
1 Intubation Attempts
Standard Deviation 0
|
1 Intubation Attempts
Standard Deviation 0
|
1 Intubation Attempts
Standard Deviation 0
|
SECONDARY outcome
Timeframe: During intubation procedure, up to 1 minutePopulation: Measure Description: The study was terminated early, only FIVE (5) subjects total were enrolled for the three arms groups. It is impossible to produce meaningful results having only five subjects enrolled.
Grade Description Approximate frequency Likelihood of difficult intubation 1. Full view of glottis 68-74% \<1% 2. a Partial view of glottis 21-24% 4.3-13.4% 2b Only posterior extremity of glottis seen or only arytenoid cartilages 3.3-6.5% 65-67.4% 3 Only epiglottis seen, none of glottis seen 1.2-1.6% 80-87.5% 4 Neither glottis nor epiglottis seen very rare Note: In the analysis of the data collected for 5 participants, there was no differentiation between "2a" and "2b" for a grade of "2."
Outcome measures
| Measure |
Blade MAC Size 3
n=1 Participants
Patient will be intubated using a:
Direct Laryngoscope (DL) Mac size 3 (Sun-Med GreenLine®/D™ Macintosh)
Blade MAC size 3: Patient will be intubated using the DL- Blade MAC size 3
|
Blade MAC Size 3.5
n=3 Participants
Patient will be intubated using a:
DL-blade mac size 3.5 (Sun-Med Greenline®/D™ Macintosh)
Blade MAC size 3.5: Patient will be intubated using the DL- Blade MAC size 3.5
|
Inscope Blade Size 3.5
n=1 Participants
Patient will be intubated using a:
Inscope DL-blade size 3.5
Inscope Blade size 3.5: Patient will be intubated using the Inscope Blade size 3.5
|
|---|---|---|---|
|
Glottis Visualization Using Cormack Lehane
|
2 score on a scale
Standard Deviation 0
|
1.3 score on a scale
Standard Deviation 0.6
|
2 score on a scale
Standard Deviation 0
|
Adverse Events
Blade MAC Size 3
Blade MAC Size 3.5
Inscope Blade Size 3.5
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Ofelia Loani Elvir Lazo, Research Project Advisor
Cedars Sinai Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place