Trial Outcomes & Findings for AMBU AScope2 Fiberoptic Intubation Versus Fastrach Intubating LMA (NCT NCT01656967)
NCT ID: NCT01656967
Last Updated: 2018-11-08
Results Overview
Total Intubation Time includes time for SGA insertion and for ETT insertion. The total time to intubation was measured from the beginning of SGA insertion to successful endotracheal tube intubation verified by detection of CO2 on the capnogram.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
66 participants
Primary outcome timeframe
Duration of Intubation, including supraglottic airway (SGA) insertion and endotracheal tube (ETT) insertion
Results posted on
2018-11-08
Participant Flow
Participant milestones
| Measure |
AMBU Aura-I/aScope 2
First, the AMBU Aura-I LMA will be inserted. Then, then patient will be intubated with assistance of the AMBU aScope 2 disposable fiberoptic system.
AMBU Aura-I LMA and aScope 2 Disposable Fiberoptic Camera
|
LMA Fastrach
The LMA Fastrach Single Use Laryngeal Mask Airway (The Laryngeal Mask Airway Company, California) will be placed, followed by blind intubation using the LMA Fastrach EndoTracheal Tube.
LMA Fastrach Single Use
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
33
|
|
Overall Study
SGA Placement
|
32
|
33
|
|
Overall Study
ETT Insertion
|
29
|
31
|
|
Overall Study
COMPLETED
|
29
|
31
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
| Measure |
AMBU Aura-I/aScope 2
First, the AMBU Aura-I LMA will be inserted. Then, then patient will be intubated with assistance of the AMBU aScope 2 disposable fiberoptic system.
AMBU Aura-I LMA and aScope 2 Disposable Fiberoptic Camera
|
LMA Fastrach
The LMA Fastrach Single Use Laryngeal Mask Airway (The Laryngeal Mask Airway Company, California) will be placed, followed by blind intubation using the LMA Fastrach EndoTracheal Tube.
LMA Fastrach Single Use
|
|---|---|---|
|
Overall Study
faulty monitor
|
1
|
0
|
|
Overall Study
unsuccessful ETT insertion
|
3
|
2
|
Baseline Characteristics
AMBU AScope2 Fiberoptic Intubation Versus Fastrach Intubating LMA
Baseline characteristics by cohort
| Measure |
AMBU Aura-I/aScope 2
n=32 Participants
First, the AMBU Aura-I LMA will be inserted. Then, then patient will be intubated with assistance of the AMBU aScope 2 disposable fiberoptic system.
AMBU Aura-I LMA and aScope 2 Disposable Fiberoptic Camera
|
LMA Fastrach
n=33 Participants
The LMA Fastrach Single Use Laryngeal Mask Airway (The Laryngeal Mask Airway Company, California) will be placed, followed by blind intubation using the LMA Fastrach EndoTracheal Tube.
LMA Fastrach Single Use
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.8 years
STANDARD_DEVIATION 13.7 • n=5 Participants
|
44.4 years
STANDARD_DEVIATION 13.7 • n=7 Participants
|
42.1 years
STANDARD_DEVIATION 13.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=5 Participants
|
33 participants
n=7 Participants
|
65 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Duration of Intubation, including supraglottic airway (SGA) insertion and endotracheal tube (ETT) insertionTotal Intubation Time includes time for SGA insertion and for ETT insertion. The total time to intubation was measured from the beginning of SGA insertion to successful endotracheal tube intubation verified by detection of CO2 on the capnogram.
Outcome measures
| Measure |
AMBU Aura-I/aScope 2
n=29 Participants
First, the AMBU Aura-I LMA will be inserted. Then, then patient will be intubated with assistance of the AMBU aScope 2 disposable fiberoptic system.
AMBU Aura-I LMA and aScope 2 Disposable Fiberoptic Camera
|
LMA Fastrach
n=31 Participants
The LMA Fastrach Single Use Laryngeal Mask Airway (The Laryngeal Mask Airway Company, California) will be placed, followed by blind intubation using the LMA Fastrach EndoTracheal Tube.
LMA Fastrach Single Use
|
|---|---|---|
|
Total Intubation Time
|
89.6 seconds
Interval 67.8 to 117.5
|
52.1 seconds
Interval 46.4 to 69.8
|
SECONDARY outcome
Timeframe: At SGA insertionTime for SGA insertion was measured from when the tip of the cuff was at the mouth to detection of CO2 on the capnogram.
Outcome measures
| Measure |
AMBU Aura-I/aScope 2
n=32 Participants
First, the AMBU Aura-I LMA will be inserted. Then, then patient will be intubated with assistance of the AMBU aScope 2 disposable fiberoptic system.
AMBU Aura-I LMA and aScope 2 Disposable Fiberoptic Camera
|
LMA Fastrach
n=33 Participants
The LMA Fastrach Single Use Laryngeal Mask Airway (The Laryngeal Mask Airway Company, California) will be placed, followed by blind intubation using the LMA Fastrach EndoTracheal Tube.
LMA Fastrach Single Use
|
|---|---|---|
|
Time for Supraglottic Airway (SGA) Insertion
|
28.6 seconds
Interval 20.9 to 37.9
|
30.3 seconds
Interval 23.0 to 36.8
|
SECONDARY outcome
Timeframe: At ETT insertionAfter the SGA is inserted, time for intubation will be recorded. Time for ETT insertion was measured, for arm 1, from when the AMBU aScope is at the connector level of the Aura-I or, for arm 2, from when the ETT is at the connector level of the Intubating LMA to first detection of CO2 on the capnogram. The AScope 2 disposable fiberoptic camera will be used to assist with intubation for Group 1 patients. Group 2 patients will be intubated using the LMA-Fastrach EndoTracheal Tube.
Outcome measures
| Measure |
AMBU Aura-I/aScope 2
n=29 Participants
First, the AMBU Aura-I LMA will be inserted. Then, then patient will be intubated with assistance of the AMBU aScope 2 disposable fiberoptic system.
AMBU Aura-I LMA and aScope 2 Disposable Fiberoptic Camera
|
LMA Fastrach
n=31 Participants
The LMA Fastrach Single Use Laryngeal Mask Airway (The Laryngeal Mask Airway Company, California) will be placed, followed by blind intubation using the LMA Fastrach EndoTracheal Tube.
LMA Fastrach Single Use
|
|---|---|---|
|
Time for Endotracheal Tube (ETT) Insertion
|
60.9 seconds
Interval 41.0 to 84.0
|
23.1 seconds
Interval 20.6 to 33.0
|
SECONDARY outcome
Timeframe: At SGA insertionOutcome measures
| Measure |
AMBU Aura-I/aScope 2
n=32 Participants
First, the AMBU Aura-I LMA will be inserted. Then, then patient will be intubated with assistance of the AMBU aScope 2 disposable fiberoptic system.
AMBU Aura-I LMA and aScope 2 Disposable Fiberoptic Camera
|
LMA Fastrach
n=33 Participants
The LMA Fastrach Single Use Laryngeal Mask Airway (The Laryngeal Mask Airway Company, California) will be placed, followed by blind intubation using the LMA Fastrach EndoTracheal Tube.
LMA Fastrach Single Use
|
|---|---|---|
|
Number of Participants in Whom SGA Insertion Was Successful on the First Attempt
|
30 participants
|
30 participants
|
SECONDARY outcome
Timeframe: At ETT insertionOutcome measures
| Measure |
AMBU Aura-I/aScope 2
n=32 Participants
First, the AMBU Aura-I LMA will be inserted. Then, then patient will be intubated with assistance of the AMBU aScope 2 disposable fiberoptic system.
AMBU Aura-I LMA and aScope 2 Disposable Fiberoptic Camera
|
LMA Fastrach
n=33 Participants
The LMA Fastrach Single Use Laryngeal Mask Airway (The Laryngeal Mask Airway Company, California) will be placed, followed by blind intubation using the LMA Fastrach EndoTracheal Tube.
LMA Fastrach Single Use
|
|---|---|---|
|
Number of Participants in Whom ETT Insertion Was Successful on the First Attempt
|
26 participants
|
27 participants
|
SECONDARY outcome
Timeframe: At SGA insertionEase of SGA insertion is subjectively assessed by the operator on a scale from 1 to 5 (1 = extremely easy, 5 = extremely difficult).
Outcome measures
| Measure |
AMBU Aura-I/aScope 2
n=33 Participants
First, the AMBU Aura-I LMA will be inserted. Then, then patient will be intubated with assistance of the AMBU aScope 2 disposable fiberoptic system.
AMBU Aura-I LMA and aScope 2 Disposable Fiberoptic Camera
|
LMA Fastrach
n=33 Participants
The LMA Fastrach Single Use Laryngeal Mask Airway (The Laryngeal Mask Airway Company, California) will be placed, followed by blind intubation using the LMA Fastrach EndoTracheal Tube.
LMA Fastrach Single Use
|
|---|---|---|
|
Number of Participants With Overall Success for SGA Placement
|
30 participants
|
30 participants
|
SECONDARY outcome
Timeframe: At ETT insertionEase of ETT insertion is subjectively assessed by the operator on a scale from 1 to 5 (1 = extremely easy, 5 = extremely difficult).
Outcome measures
| Measure |
AMBU Aura-I/aScope 2
n=33 Participants
First, the AMBU Aura-I LMA will be inserted. Then, then patient will be intubated with assistance of the AMBU aScope 2 disposable fiberoptic system.
AMBU Aura-I LMA and aScope 2 Disposable Fiberoptic Camera
|
LMA Fastrach
n=33 Participants
The LMA Fastrach Single Use Laryngeal Mask Airway (The Laryngeal Mask Airway Company, California) will be placed, followed by blind intubation using the LMA Fastrach EndoTracheal Tube.
LMA Fastrach Single Use
|
|---|---|---|
|
Number of Participant With Overall Intubation Success
|
29 participant
|
31 participant
|
SECONDARY outcome
Timeframe: Within 30 minutes of completion of surgeryThe patient will be assessed for Post-Operative Hoarseness, Sore Mouth, Sore Neck, Sore Jaw, Dysphonia, Dysphagia, and Altered Tongue Sensation.
Outcome measures
| Measure |
AMBU Aura-I/aScope 2
n=33 Participants
First, the AMBU Aura-I LMA will be inserted. Then, then patient will be intubated with assistance of the AMBU aScope 2 disposable fiberoptic system.
AMBU Aura-I LMA and aScope 2 Disposable Fiberoptic Camera
|
LMA Fastrach
n=33 Participants
The LMA Fastrach Single Use Laryngeal Mask Airway (The Laryngeal Mask Airway Company, California) will be placed, followed by blind intubation using the LMA Fastrach EndoTracheal Tube.
LMA Fastrach Single Use
|
|---|---|---|
|
Post-Operative Discomfort Upon Entering the Post-Anesthesia Care Unit (PACU)
|
29 participants
|
30 participants
|
SECONDARY outcome
Timeframe: Approximately 1-2 hours after entering the PACUThe patient will be assessed for Post-Operative Hoarseness, Sore Mouth, Sore Neck, Sore Jaw, Dysphonia, Dysphagia, and Altered Tongue Sensation.
Outcome measures
| Measure |
AMBU Aura-I/aScope 2
n=33 Participants
First, the AMBU Aura-I LMA will be inserted. Then, then patient will be intubated with assistance of the AMBU aScope 2 disposable fiberoptic system.
AMBU Aura-I LMA and aScope 2 Disposable Fiberoptic Camera
|
LMA Fastrach
n=33 Participants
The LMA Fastrach Single Use Laryngeal Mask Airway (The Laryngeal Mask Airway Company, California) will be placed, followed by blind intubation using the LMA Fastrach EndoTracheal Tube.
LMA Fastrach Single Use
|
|---|---|---|
|
Post-Operative Discomfort Upon Leaving the Post-Anesthesia Care Unit (PACU)
|
29 participants
|
30 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Following SGA InsertionThe oropharyngeal leak pressure (OLP) was determined by closing the expiratory valve of the circle system at a fixed gas flow of 3 L/min and noting the airway pressure at which equilibrium was reached (not permitted to exceed 40 cm H2O).
Outcome measures
| Measure |
AMBU Aura-I/aScope 2
n=32 Participants
First, the AMBU Aura-I LMA will be inserted. Then, then patient will be intubated with assistance of the AMBU aScope 2 disposable fiberoptic system.
AMBU Aura-I LMA and aScope 2 Disposable Fiberoptic Camera
|
LMA Fastrach
n=33 Participants
The LMA Fastrach Single Use Laryngeal Mask Airway (The Laryngeal Mask Airway Company, California) will be placed, followed by blind intubation using the LMA Fastrach EndoTracheal Tube.
LMA Fastrach Single Use
|
|---|---|---|
|
Orolaryngeal Pressure
|
28.0 mmHg
Interval 24.5 to 30.0
|
26.0 mmHg
Interval 24.0 to 30.0
|
Adverse Events
AMBU Aura-I/aScope 2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
LMA Fastrach
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AMBU Aura-I/aScope 2
n=29 participants at risk
First, the AMBU Aura-I LMA will be inserted. Then, then patient will be intubated with assistance of the AMBU aScope 2 disposable fiberoptic system.
AMBU Aura-I LMA and aScope 2 Disposable Fiberoptic Camera
|
LMA Fastrach
n=31 participants at risk
The LMA Fastrach Single Use Laryngeal Mask Airway (The Laryngeal Mask Airway Company, California) will be placed, followed by blind intubation using the LMA Fastrach EndoTracheal Tube.
LMA Fastrach Single Use
|
|---|---|---|
|
Surgical and medical procedures
Hoarseness
|
3.4%
1/29 • Number of events 13 • Adverse Event data include measures of post-operative discomfort upon entering the Post-Anesthesia Care Unit (PACU). Patients entered the PACU within 30 minutes of completion of surgery. Data collected for 6 months duration.
|
6.5%
2/31 • Number of events 16 • Adverse Event data include measures of post-operative discomfort upon entering the Post-Anesthesia Care Unit (PACU). Patients entered the PACU within 30 minutes of completion of surgery. Data collected for 6 months duration.
|
|
Surgical and medical procedures
Sore mouth
|
10.3%
3/29 • Number of events 29 • Adverse Event data include measures of post-operative discomfort upon entering the Post-Anesthesia Care Unit (PACU). Patients entered the PACU within 30 minutes of completion of surgery. Data collected for 6 months duration.
|
25.8%
8/31 • Number of events 31 • Adverse Event data include measures of post-operative discomfort upon entering the Post-Anesthesia Care Unit (PACU). Patients entered the PACU within 30 minutes of completion of surgery. Data collected for 6 months duration.
|
|
Surgical and medical procedures
Sore neck
|
3.4%
1/29 • Number of events 1 • Adverse Event data include measures of post-operative discomfort upon entering the Post-Anesthesia Care Unit (PACU). Patients entered the PACU within 30 minutes of completion of surgery. Data collected for 6 months duration.
|
9.7%
3/31 • Number of events 3 • Adverse Event data include measures of post-operative discomfort upon entering the Post-Anesthesia Care Unit (PACU). Patients entered the PACU within 30 minutes of completion of surgery. Data collected for 6 months duration.
|
|
Surgical and medical procedures
Sore Jaw
|
0.00%
0/29 • Adverse Event data include measures of post-operative discomfort upon entering the Post-Anesthesia Care Unit (PACU). Patients entered the PACU within 30 minutes of completion of surgery. Data collected for 6 months duration.
|
3.2%
1/31 • Number of events 1 • Adverse Event data include measures of post-operative discomfort upon entering the Post-Anesthesia Care Unit (PACU). Patients entered the PACU within 30 minutes of completion of surgery. Data collected for 6 months duration.
|
|
Surgical and medical procedures
Dysphonia
|
3.4%
1/29 • Number of events 5 • Adverse Event data include measures of post-operative discomfort upon entering the Post-Anesthesia Care Unit (PACU). Patients entered the PACU within 30 minutes of completion of surgery. Data collected for 6 months duration.
|
3.2%
1/31 • Number of events 7 • Adverse Event data include measures of post-operative discomfort upon entering the Post-Anesthesia Care Unit (PACU). Patients entered the PACU within 30 minutes of completion of surgery. Data collected for 6 months duration.
|
|
Surgical and medical procedures
Dysphagia
|
10.3%
3/29 • Number of events 21 • Adverse Event data include measures of post-operative discomfort upon entering the Post-Anesthesia Care Unit (PACU). Patients entered the PACU within 30 minutes of completion of surgery. Data collected for 6 months duration.
|
6.5%
2/31 • Number of events 22 • Adverse Event data include measures of post-operative discomfort upon entering the Post-Anesthesia Care Unit (PACU). Patients entered the PACU within 30 minutes of completion of surgery. Data collected for 6 months duration.
|
|
Surgical and medical procedures
Altered tongue sensation
|
0.00%
0/29 • Adverse Event data include measures of post-operative discomfort upon entering the Post-Anesthesia Care Unit (PACU). Patients entered the PACU within 30 minutes of completion of surgery. Data collected for 6 months duration.
|
3.2%
1/31 • Number of events 1 • Adverse Event data include measures of post-operative discomfort upon entering the Post-Anesthesia Care Unit (PACU). Patients entered the PACU within 30 minutes of completion of surgery. Data collected for 6 months duration.
|
Additional Information
Dr. Carin A. Hagberg
The University of Texas Health Science Center at Houston
Phone: (713) 500-6240
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place