Trial Outcomes & Findings for Video-laryngoscope With a Novel Video-stylet for Difficult Intubation (NCT NCT01215695)
NCT ID: NCT01215695
Last Updated: 2017-09-08
Results Overview
divided into time to successfully place the glidescope (visualization of the epiglottis), time to successfully insert the videostylet (passing through the cords) and time to verified placement of the ETT (as outlined above). Interim bag and mask time, if needed, will not be included in the intubation time. More than 5 attempts or 120 s are regarded as failure of intubation. If failure to secure the airway occurs with the GVL and videostylet, then conventional difficult intubation protocols approved by the University of Louisville Hospital will be implemented.
COMPLETED
NA
140 participants
120 seconds
2017-09-08
Participant Flow
Participant milestones
| Measure |
Control
Patients will be randomly assigned to having their ETT placed with use of a pre-formed stylet provided by the manufacturer of the GVL (control group)
Control: pre-formed stylet provided by the manufacturer of the GlideScope® video laryngoscope
|
Intervention
Patients will be randomly assigned to either having their ETT placed with use of flexible, disposable tracheoscope (aScope, Ambu, Denmark) (intervention group).
aScope (Ambu Inc. 6740 Baymeadow Drive Glen Burnie, MD): The aScope is a flexible, disposable plastic tracheoscope that incorporates a high-resolution video camera with an LED light at its flexible tip and has attached monitor.
|
|---|---|---|
|
Overall Study
STARTED
|
70
|
70
|
|
Overall Study
COMPLETED
|
70
|
70
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Video-laryngoscope With a Novel Video-stylet for Difficult Intubation
Baseline characteristics by cohort
| Measure |
Control
n=70 Participants
Patients will be randomly assigned to having their ETT placed with use of a pre-formed stylet provided by the manufacturer of the GVL (control group)
Control: pre-formed stylet provided by the manufacturer of the GlideScope® video laryngoscope
|
Intervention
n=70 Participants
Patients will be randomly assigned to either having their ETT placed with use of flexible, disposable tracheoscope (aScope, Ambu, Denmark) (intervention group).
aScope (Ambu Inc. 6740 Baymeadow Drive Glen Burnie, MD): The aScope is a flexible, disposable plastic tracheoscope that incorporates a high-resolution video camera with an LED light at its flexible tip and has attached monitor.
|
Total
n=140 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45 years
STANDARD_DEVIATION 13 • n=99 Participants
|
46 years
STANDARD_DEVIATION 14 • n=107 Participants
|
45 years
STANDARD_DEVIATION 13 • n=206 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
64 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
76 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
70 participants
n=99 Participants
|
70 participants
n=107 Participants
|
140 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 120 secondsdivided into time to successfully place the glidescope (visualization of the epiglottis), time to successfully insert the videostylet (passing through the cords) and time to verified placement of the ETT (as outlined above). Interim bag and mask time, if needed, will not be included in the intubation time. More than 5 attempts or 120 s are regarded as failure of intubation. If failure to secure the airway occurs with the GVL and videostylet, then conventional difficult intubation protocols approved by the University of Louisville Hospital will be implemented.
Outcome measures
| Measure |
Control
n=70 Participants
Patients will be randomly assigned to having their ETT placed with use of a pre-formed stylet provided by the manufacturer of the GVL (control group)
Control: pre-formed stylet provided by the manufacturer of the GlideScope® video laryngoscope
|
Intervention
n=70 Participants
Patients will be randomly assigned to either having their ETT placed with use of flexible, disposable tracheoscope (aScope, Ambu, Denmark) (intervention group).
aScope (Ambu Inc. 6740 Baymeadow Drive Glen Burnie, MD): The aScope is a flexible, disposable plastic tracheoscope that incorporates a high-resolution video camera with an LED light at its flexible tip and has attached monitor.
|
|---|---|---|
|
Intubation Time
|
66 time in seconds
Interval 47.0 to 89.0
|
71 time in seconds
Interval 52.0 to 100.0
|
SECONDARY outcome
Timeframe: 30 minutescounted as each approach of the ETT to the glottic entrance.
Outcome measures
| Measure |
Control
n=70 Participants
Patients will be randomly assigned to having their ETT placed with use of a pre-formed stylet provided by the manufacturer of the GVL (control group)
Control: pre-formed stylet provided by the manufacturer of the GlideScope® video laryngoscope
|
Intervention
n=70 Participants
Patients will be randomly assigned to either having their ETT placed with use of flexible, disposable tracheoscope (aScope, Ambu, Denmark) (intervention group).
aScope (Ambu Inc. 6740 Baymeadow Drive Glen Burnie, MD): The aScope is a flexible, disposable plastic tracheoscope that incorporates a high-resolution video camera with an LED light at its flexible tip and has attached monitor.
|
|---|---|---|
|
The Number of Intubation Attempts
|
1.2 Number of intubation attempts
Standard Deviation 0.6
|
1.1 Number of intubation attempts
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: 30 minutesPopulation: Only those participants with available data were analyzed for the assessment. All subjects reported had mild, moderate or severe neck movement.
One observer will video-record the entire intubation procedure. At a later time, an otherwise unrelated observer will watch the video-records and grade the neck movement during intubation. Neck movement will be classified as Grade 0: no neck movement, Grade 1: minimal neck movement, or Grade 2: moderate neck movement. Results are reported as total with mild, moderate, or severe neck movement.
Outcome measures
| Measure |
Control
n=47 Participants
Patients will be randomly assigned to having their ETT placed with use of a pre-formed stylet provided by the manufacturer of the GVL (control group)
Control: pre-formed stylet provided by the manufacturer of the GlideScope® video laryngoscope
|
Intervention
n=54 Participants
Patients will be randomly assigned to either having their ETT placed with use of flexible, disposable tracheoscope (aScope, Ambu, Denmark) (intervention group).
aScope (Ambu Inc. 6740 Baymeadow Drive Glen Burnie, MD): The aScope is a flexible, disposable plastic tracheoscope that incorporates a high-resolution video camera with an LED light at its flexible tip and has attached monitor.
|
|---|---|---|
|
Neck Movement
|
47 Participants
|
54 Participants
|
SECONDARY outcome
Timeframe: 30 minutesThe laryngeal view as Grade 1 (full view of the glottis) or Grade 2 (glottis partly exposed, anterior commissure not seen) according to the method described by Cormack and Lehane (1984).
Outcome measures
| Measure |
Control
n=70 Participants
Patients will be randomly assigned to having their ETT placed with use of a pre-formed stylet provided by the manufacturer of the GVL (control group)
Control: pre-formed stylet provided by the manufacturer of the GlideScope® video laryngoscope
|
Intervention
n=70 Participants
Patients will be randomly assigned to either having their ETT placed with use of flexible, disposable tracheoscope (aScope, Ambu, Denmark) (intervention group).
aScope (Ambu Inc. 6740 Baymeadow Drive Glen Burnie, MD): The aScope is a flexible, disposable plastic tracheoscope that incorporates a high-resolution video camera with an LED light at its flexible tip and has attached monitor.
|
|---|---|---|
|
Laryngeal View Grade of 1 or 2
|
62 Participants
|
50 Participants
|
SECONDARY outcome
Timeframe: 2-4 hours after intubationAfter completion of the procedure the intubator will be asked to score the ease of intubation. To do this, he/she will give a score from 0-100 with 0 being the easiest and 100 being the hardest.
Outcome measures
| Measure |
Control
n=70 Participants
Patients will be randomly assigned to having their ETT placed with use of a pre-formed stylet provided by the manufacturer of the GVL (control group)
Control: pre-formed stylet provided by the manufacturer of the GlideScope® video laryngoscope
|
Intervention
n=70 Participants
Patients will be randomly assigned to either having their ETT placed with use of flexible, disposable tracheoscope (aScope, Ambu, Denmark) (intervention group).
aScope (Ambu Inc. 6740 Baymeadow Drive Glen Burnie, MD): The aScope is a flexible, disposable plastic tracheoscope that incorporates a high-resolution video camera with an LED light at its flexible tip and has attached monitor.
|
|---|---|---|
|
Ease of Intubation
|
36 units on a scale
Standard Deviation 23
|
39 units on a scale
Standard Deviation 25
|
Adverse Events
Control
Intervention
Serious adverse events
| Measure |
Control
n=70 participants at risk
Patients will be randomly assigned to having their ETT placed with use of a pre-formed stylet provided by the manufacturer of the GVL (control group)
Control: pre-formed stylet provided by the manufacturer of the GlideScope® video laryngoscope
|
Intervention
n=70 participants at risk
Patients will be randomly assigned to either having their ETT placed with use of flexible, disposable tracheoscope (aScope, Ambu, Denmark) (intervention group).
aScope (Ambu Inc. 6740 Baymeadow Drive Glen Burnie, MD): The aScope is a flexible, disposable plastic tracheoscope that incorporates a high-resolution video camera with an LED light at its flexible tip and has attached monitor.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Unable to intubate
|
2.9%
2/70 • Number of events 2
|
2.9%
2/70 • Number of events 2
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place