Trial Outcomes & Findings for Ambu AuraGain and Teleflex LMA Protector Fiberoptic Assessments in Elective Patients (NCT NCT02724956)
NCT ID: NCT02724956
Last Updated: 2021-09-27
Results Overview
Success defined as correct placement of SGAD. 1st Attempt success of SGAD either Ambu AuraGain or Teleflex LMA Protector during insertion and placement into an airway.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
53 participants
Primary outcome timeframe
from Anesthesia Start to Anesthesia Stop, approximately 1 hour
Results posted on
2021-09-27
Participant Flow
Participant milestones
| Measure |
Ambu AuraGain
Pre-curved, rigid airway tube, SGAD. Third generation Ambu laryngeal mask satisfying 3 fundamental airway management needs by integrating gastric access and intubation capability in an anatomically curved single-use device that facilitates rapid establishment of a safe airway. A SGAD used for ventilation, and a conduit for intubation. SGAD insertion followed by fiber-optic evaluation using Ambu aScope.
|
Teleflex LMA Protector
Pre-curved, rigid airway tube, SGAD: A next-generation, single-use laryngeal mask with a dual gastric drainage channel and pharyngeal chamber. A SGAD used for ventilation, and a conduit for intubation. SGAD insertion followed by fiber-optic evaluation using Ambu aScope.
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
26
|
|
Overall Study
COMPLETED
|
26
|
24
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Ambu AuraGain
Pre-curved, rigid airway tube, SGAD. Third generation Ambu laryngeal mask satisfying 3 fundamental airway management needs by integrating gastric access and intubation capability in an anatomically curved single-use device that facilitates rapid establishment of a safe airway. A SGAD used for ventilation, and a conduit for intubation. SGAD insertion followed by fiber-optic evaluation using Ambu aScope.
|
Teleflex LMA Protector
Pre-curved, rigid airway tube, SGAD: A next-generation, single-use laryngeal mask with a dual gastric drainage channel and pharyngeal chamber. A SGAD used for ventilation, and a conduit for intubation. SGAD insertion followed by fiber-optic evaluation using Ambu aScope.
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Ambu AuraGain
n=26 Participants
SGAD placement using Ambu AuraGain
* Lubricate airway tube of SGAD \& pass the aScope through until visualization of the carina.
* Standard Parker Flex Tip endotracheal tube (ETT) size 6.0, 7.0, and 8.0 mm ETT will be used as per anesthesiologist preference.
* Pass ETT tube down the insertion cord of the Ambu aScope \& verify placement.
* Inflate cuff and remove aScope.
Ambu AuraGain: Pre-curved, rigid airway tube, SGAD. Third generation Ambu laryngeal mask satisfying 3 fundamental airway management needs by integrating gastric access and intubation capability in an anatomically curved single-use device that facilitates rapid establishment of a safe airway. A SGAD used for ventilation, and a conduit for intubation. SGAD insertion followed by fiber-optic evaluation using Ambu aScope.
Ambu aScope: Flexible scope which will be introduced into airway tube and guided through the SGAD until it will be possible to view the vocal cords. Description of the maximal optical view will be measured by the Percentage of Glottic Opening (POGO).
|
Teleflex LMA Protector
n=24 Participants
SGAD placement using the Teleflex LMA Protector
* Lubricate airway tube of SGAD \& pass the aScope through until visualization of the carina.
* Standard Parker Flex Tip ETT size 6.0 and 7.0 mm. ETT will be used as per anesthesiologist preference.
* Pass ETT tube down the insertion cord of the Ambu aScope \& verify placement.
* Inflate cuff and remove aScope.
Teleflex LMA Protector: Pre-curved, rigid airway tube, SGAD: A next-generation, single-use laryngeal mask with a dual gastric drainage channel and pharyngeal chamber. A SGAD used for ventilation, and a conduit for intubation. SGAD insertion followed by fiber-optic evaluation using Ambu aScope.
Ambu aScope: Flexible scope which will be introduced into airway tube and guided through the SGAD until it will be possible to view the vocal cords. Description of the maximal optical view will be measured by the Percentage of Glottic Opening (POGO).
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=26 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=50 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=26 Participants
|
15 Participants
n=24 Participants
|
35 Participants
n=50 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=26 Participants
|
9 Participants
n=24 Participants
|
15 Participants
n=50 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=26 Participants
|
18 Participants
n=24 Participants
|
39 Participants
n=50 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=26 Participants
|
6 Participants
n=24 Participants
|
11 Participants
n=50 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
26 participants
n=26 Participants
|
24 participants
n=24 Participants
|
50 participants
n=50 Participants
|
|
Supraglottic Airway (SGA) Sizes
SGA Size 3
|
6 Participants
n=26 Participants
|
5 Participants
n=24 Participants
|
11 Participants
n=50 Participants
|
|
Supraglottic Airway (SGA) Sizes
SGA Size 4
|
19 Participants
n=26 Participants
|
17 Participants
n=24 Participants
|
36 Participants
n=50 Participants
|
|
Supraglottic Airway (SGA) Sizes
SGA Size 5
|
1 Participants
n=26 Participants
|
2 Participants
n=24 Participants
|
3 Participants
n=50 Participants
|
PRIMARY outcome
Timeframe: from Anesthesia Start to Anesthesia Stop, approximately 1 hourSuccess defined as correct placement of SGAD. 1st Attempt success of SGAD either Ambu AuraGain or Teleflex LMA Protector during insertion and placement into an airway.
Outcome measures
| Measure |
Ambu AuraGain
n=26 Participants
Pre-curved, rigid airway tube, SGAD. Third generation Ambu laryngeal mask satisfying 3 fundamental airway management needs by integrating gastric access and intubation capability in an anatomically curved single-use device that facilitates rapid establishment of a safe airway. A SGAD used for ventilation, and a conduit for intubation. SGAD insertion followed by fiber-optic evaluation using Ambu aScope.
|
Teleflex LMA Protector
n=24 Participants
Pre-curved, rigid airway tube, SGAD: A next-generation, single-use laryngeal mask with a dual gastric drainage channel and pharyngeal chamber. A SGAD used for ventilation, and a conduit for intubation. SGAD insertion followed by fiber-optic evaluation using Ambu aScope.
|
|---|---|---|
|
1st Attempt Success With Supraglottic Airway Devices (SGAD)
Successful
|
25 Participants
|
21 Participants
|
|
1st Attempt Success With Supraglottic Airway Devices (SGAD)
Unsuccessful
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: from Anesthesia Start to Anesthesia Stop, approximately 1 hourPopulation: 8 participants were not recorded due to protocol deviation
OLP measured by a portable, handheld manometer.
Outcome measures
| Measure |
Ambu AuraGain
n=21 Participants
Pre-curved, rigid airway tube, SGAD. Third generation Ambu laryngeal mask satisfying 3 fundamental airway management needs by integrating gastric access and intubation capability in an anatomically curved single-use device that facilitates rapid establishment of a safe airway. A SGAD used for ventilation, and a conduit for intubation. SGAD insertion followed by fiber-optic evaluation using Ambu aScope.
|
Teleflex LMA Protector
n=21 Participants
Pre-curved, rigid airway tube, SGAD: A next-generation, single-use laryngeal mask with a dual gastric drainage channel and pharyngeal chamber. A SGAD used for ventilation, and a conduit for intubation. SGAD insertion followed by fiber-optic evaluation using Ambu aScope.
|
|---|---|---|
|
Oropharyngeal Leak Pressure (OLP)
|
35 cmH2O
Interval 22.0 to 68.0
|
37 cmH2O
Interval 15.0 to 56.2
|
SECONDARY outcome
Timeframe: from Anesthesia Start to Anesthesia Stop, approximately 1 hourPopulation: 1 participant was not analyzed in the Teleflex LMA Protector Arm due to device failure
Rate of successful intubation and ventilation by utilizing the SGAD as an intubation conduit guided by the Ambu® aScope™ 3 Slim.
Outcome measures
| Measure |
Ambu AuraGain
n=26 Participants
Pre-curved, rigid airway tube, SGAD. Third generation Ambu laryngeal mask satisfying 3 fundamental airway management needs by integrating gastric access and intubation capability in an anatomically curved single-use device that facilitates rapid establishment of a safe airway. A SGAD used for ventilation, and a conduit for intubation. SGAD insertion followed by fiber-optic evaluation using Ambu aScope.
|
Teleflex LMA Protector
n=23 Participants
Pre-curved, rigid airway tube, SGAD: A next-generation, single-use laryngeal mask with a dual gastric drainage channel and pharyngeal chamber. A SGAD used for ventilation, and a conduit for intubation. SGAD insertion followed by fiber-optic evaluation using Ambu aScope.
|
|---|---|---|
|
Number of Participants With a Rate of Successful Intubation and Ventilation
Successful
|
21 Participants
|
19 Participants
|
|
Number of Participants With a Rate of Successful Intubation and Ventilation
Unsuccessful
|
5 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: from Anesthesia Start to Anesthesia Stop, approximately 1 hourQualitative Assessment scale range of 1-4. (1) Easy; (2) Resistance, (3) Difficult; and (4) Unsuccessful.
Outcome measures
| Measure |
Ambu AuraGain
n=26 Participants
Pre-curved, rigid airway tube, SGAD. Third generation Ambu laryngeal mask satisfying 3 fundamental airway management needs by integrating gastric access and intubation capability in an anatomically curved single-use device that facilitates rapid establishment of a safe airway. A SGAD used for ventilation, and a conduit for intubation. SGAD insertion followed by fiber-optic evaluation using Ambu aScope.
|
Teleflex LMA Protector
n=24 Participants
Pre-curved, rigid airway tube, SGAD: A next-generation, single-use laryngeal mask with a dual gastric drainage channel and pharyngeal chamber. A SGAD used for ventilation, and a conduit for intubation. SGAD insertion followed by fiber-optic evaluation using Ambu aScope.
|
|---|---|---|
|
Number of Participants With Ease of SGAD Insertion
Resistance
|
1 Participants
|
2 Participants
|
|
Number of Participants With Ease of SGAD Insertion
Easy
|
25 Participants
|
21 Participants
|
|
Number of Participants With Ease of SGAD Insertion
Difficult
|
0 Participants
|
0 Participants
|
|
Number of Participants With Ease of SGAD Insertion
Unsuccessful
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: from Anesthesia Start to Anesthesia Stop, approximately 1 hourPOGO Score of 100% on First Attempt at Device Placement. All participant assessments and observations (clinical data) completed and recorded during the 1st visit
Outcome measures
| Measure |
Ambu AuraGain
n=26 Participants
Pre-curved, rigid airway tube, SGAD. Third generation Ambu laryngeal mask satisfying 3 fundamental airway management needs by integrating gastric access and intubation capability in an anatomically curved single-use device that facilitates rapid establishment of a safe airway. A SGAD used for ventilation, and a conduit for intubation. SGAD insertion followed by fiber-optic evaluation using Ambu aScope.
|
Teleflex LMA Protector
n=24 Participants
Pre-curved, rigid airway tube, SGAD: A next-generation, single-use laryngeal mask with a dual gastric drainage channel and pharyngeal chamber. A SGAD used for ventilation, and a conduit for intubation. SGAD insertion followed by fiber-optic evaluation using Ambu aScope.
|
|---|---|---|
|
Glottic Opening (POGO)
POGO- Observed
|
26 Participants
|
20 Participants
|
|
Glottic Opening (POGO)
POGO- Not Observed
|
0 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: from Anesthesia Start to Anesthesia Stop, approximately 1 hourPopulation: 1 participant was not analyzed in the Teleflex LMA Protector Arm due to device failure
Functionality of gastric drainage channel which will be inserted through the appropriate channel of the SGAD.
Outcome measures
| Measure |
Ambu AuraGain
n=26 Participants
Pre-curved, rigid airway tube, SGAD. Third generation Ambu laryngeal mask satisfying 3 fundamental airway management needs by integrating gastric access and intubation capability in an anatomically curved single-use device that facilitates rapid establishment of a safe airway. A SGAD used for ventilation, and a conduit for intubation. SGAD insertion followed by fiber-optic evaluation using Ambu aScope.
|
Teleflex LMA Protector
n=23 Participants
Pre-curved, rigid airway tube, SGAD: A next-generation, single-use laryngeal mask with a dual gastric drainage channel and pharyngeal chamber. A SGAD used for ventilation, and a conduit for intubation. SGAD insertion followed by fiber-optic evaluation using Ambu aScope.
|
|---|---|---|
|
Functionality of Gastric Tube Placement
Easy
|
26 Participants
|
16 Participants
|
|
Functionality of Gastric Tube Placement
Resistance
|
0 Participants
|
1 Participants
|
|
Functionality of Gastric Tube Placement
Difficult
|
0 Participants
|
0 Participants
|
|
Functionality of Gastric Tube Placement
Unsuccessful
|
0 Participants
|
6 Participants
|
Adverse Events
Ambu AuraGain
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Teleflex LMA Protector
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
Carin Hagberg, MD/Chief Academic Officer, CAO Office
UT MD Anderson Cancer Center
Phone: 713-792-5888
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place