Trial Outcomes & Findings for Comparison of Endotracheal Intubation Over the Aintree Via the I-gel and Laryngeal Mask Airway Supreme (NCT NCT02476565)
NCT ID: NCT02476565
Last Updated: 2018-03-16
Results Overview
This measure of time begins with the handling of the supraglottic device to confirming the appropriate placement of the device by noting the presences of end tidal carbon dioxide.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
39 participants
Primary outcome timeframe
Up to 10 minutes
Results posted on
2018-03-16
Participant Flow
Participant milestones
| Measure |
I-gel Supraglottic Device
The I-gel is an alternative supraglottic device made from thermoplastic elastomer which provides the seal over the airway versus an inflatable cuff.
I-gel supraglottic device: The fiberscope (with the Aintree loaded on top of it) will be advanced through the supraglottic device into the trachea. Next, the supraglottic device will be removed and the endotracheal tube will be advanced into the airway over the Aintree airway intubation catheter. Finally, the Aintree catheter is removed and the endotracheal tube will be left in the airway.
|
LMA-Supreme Supraglottic Device
The LMA-Supreme is a single-use disposable supraglottic airway that utilizes an inflatable cuff
LMA-Supreme supraglottic device: The fiberscope (with the Aintree loaded on top of it) will be advanced through the supraglottic device into the trachea. Next, the supraglottic device will be removed and the endotracheal tube will be advanced into the airway over the Aintree airway intubation catheter. Finally, the Aintree catheter is removed and the endotracheal tube will be left in the airway.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
19
|
|
Overall Study
COMPLETED
|
20
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Data not available for 10 subjects
Baseline characteristics by cohort
| Measure |
LMA-Supreme Supraglottic Device
n=19 Participants
The LMA-Supreme is a single-use disposable supraglottic airway that utilizes an inflatable cuff
LMA-Supreme supraglottic device: The fiberscope (with the Aintree loaded on top of it) will be advanced through the supraglottic device into the trachea. Next, the supraglottic device will be removed and the endotracheal tube will be advanced into the airway over the Aintree airway intubation catheter. Finally, the Aintree catheter is removed and the endotracheal tube will be left in the airway.
|
I-gel Supraglottic Device
n=20 Participants
The I-gel is an alternative supraglottic device made from thermoplastic elastomer which provides the seal over the airway versus an inflatable cuff.
I-gel supraglottic device: The fiberscope (with the Aintree loaded on top of it) will be advanced through the supraglottic device into the trachea. Next, the supraglottic device will be removed and the endotracheal tube will be advanced into the airway over the Aintree airway intubation catheter. Finally, the Aintree catheter is removed and the endotracheal tube will be left in the airway.
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54 years
STANDARD_DEVIATION 15 • n=14 Participants • Data not available for 10 subjects
|
58 years
STANDARD_DEVIATION 14 • n=15 Participants • Data not available for 10 subjects
|
56 years
STANDARD_DEVIATION 14 • n=29 Participants • Data not available for 10 subjects
|
|
Sex: Female, Male
Female
|
1 Participants
n=15 Participants • Data not available for 10 subjects
|
2 Participants
n=14 Participants • Data not available for 10 subjects
|
3 Participants
n=29 Participants • Data not available for 10 subjects
|
|
Sex: Female, Male
Male
|
14 Participants
n=15 Participants • Data not available for 10 subjects
|
12 Participants
n=14 Participants • Data not available for 10 subjects
|
26 Participants
n=29 Participants • Data not available for 10 subjects
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
19 Participants
n=19 Participants
|
20 Participants
n=20 Participants
|
39 Participants
n=39 Participants
|
|
Body Mass Index (BMI)
|
28.3 kg/m2
STANDARD_DEVIATION 8.0 • n=19 Participants
|
27.3 kg/m2
STANDARD_DEVIATION 8.3 • n=20 Participants
|
27.7 kg/m2
STANDARD_DEVIATION 8.1 • n=39 Participants
|
PRIMARY outcome
Timeframe: Up to 10 minutesPopulation: unable to confirm accuracy of data in 1 participant in the I-gel group, that participant's data was not included in the analysis
This measure of time begins with the handling of the supraglottic device to confirming the appropriate placement of the device by noting the presences of end tidal carbon dioxide.
Outcome measures
| Measure |
I-gel Supraglottic Device
n=19 Participants
The I-gel is an alternative supraglottic device made from thermoplastic elastomer which provides the seal over the airway versus an inflatable cuff.
I-gel supraglottic device: The fiberscope (with the Aintree loaded on top of it) will be advanced through the supraglottic device into the trachea. Next, the supraglottic device will be removed and the endotracheal tube will be advanced into the airway over the Aintree airway intubation catheter. Finally, the Aintree catheter is removed and the endotracheal tube will be left in the airway.
|
LMA-Supreme Supraglottic Device
n=19 Participants
The LMA-Supreme is a single-use disposable supraglottic airway that utilizes an inflatable cuff
LMA-Supreme supraglottic device: The fiberscope (with the Aintree loaded on top of it) will be advanced through the supraglottic device into the trachea. Next, the supraglottic device will be removed and the endotracheal tube will be advanced into the airway over the Aintree airway intubation catheter. Finally, the Aintree catheter is removed and the endotracheal tube will be left in the airway.
|
|---|---|---|
|
Time to Successful Tracheal Intubation
|
197 seconds
Standard Deviation 93
|
304 seconds
Standard Deviation 173
|
SECONDARY outcome
Timeframe: Up to 10 minutesPopulation: unable to confirm accuracy of data in 1 participant in the I-gel group, that participant's data was not included in the analysis
This measure of time begins with the handling of the supra glottic device to confirming the appropriate placement of the device by noting the presences of end tidal carbon dioxide
Outcome measures
| Measure |
I-gel Supraglottic Device
n=19 Participants
The I-gel is an alternative supraglottic device made from thermoplastic elastomer which provides the seal over the airway versus an inflatable cuff.
I-gel supraglottic device: The fiberscope (with the Aintree loaded on top of it) will be advanced through the supraglottic device into the trachea. Next, the supraglottic device will be removed and the endotracheal tube will be advanced into the airway over the Aintree airway intubation catheter. Finally, the Aintree catheter is removed and the endotracheal tube will be left in the airway.
|
LMA-Supreme Supraglottic Device
n=19 Participants
The LMA-Supreme is a single-use disposable supraglottic airway that utilizes an inflatable cuff
LMA-Supreme supraglottic device: The fiberscope (with the Aintree loaded on top of it) will be advanced through the supraglottic device into the trachea. Next, the supraglottic device will be removed and the endotracheal tube will be advanced into the airway over the Aintree airway intubation catheter. Finally, the Aintree catheter is removed and the endotracheal tube will be left in the airway.
|
|---|---|---|
|
Time to Placement of the Supra Glottic Device
|
155 seconds
Standard Deviation 182
|
301 seconds
Standard Deviation 246
|
SECONDARY outcome
Timeframe: Up to 10 minutesPopulation: 4 participants in the LMA-Supreme arm were not included in analysis because the study was aborted at the request of the attending or the times to established safety cutoff for airway establishment (10 minutes) was exceeded.
Percent of subjects who required 0, 1, 2, and 3 airway manipulations for the placement of the supraglottic device
Outcome measures
| Measure |
I-gel Supraglottic Device
n=20 Participants
The I-gel is an alternative supraglottic device made from thermoplastic elastomer which provides the seal over the airway versus an inflatable cuff.
I-gel supraglottic device: The fiberscope (with the Aintree loaded on top of it) will be advanced through the supraglottic device into the trachea. Next, the supraglottic device will be removed and the endotracheal tube will be advanced into the airway over the Aintree airway intubation catheter. Finally, the Aintree catheter is removed and the endotracheal tube will be left in the airway.
|
LMA-Supreme Supraglottic Device
n=15 Participants
The LMA-Supreme is a single-use disposable supraglottic airway that utilizes an inflatable cuff
LMA-Supreme supraglottic device: The fiberscope (with the Aintree loaded on top of it) will be advanced through the supraglottic device into the trachea. Next, the supraglottic device will be removed and the endotracheal tube will be advanced into the airway over the Aintree airway intubation catheter. Finally, the Aintree catheter is removed and the endotracheal tube will be left in the airway.
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|---|---|---|
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Percent of Subjects Who Required 0, 1, 2, and 3 Airway Manipulations for the Placement of the Supraglottic Device
0 manipulations
|
80 percent of participants
|
80 percent of participants
|
|
Percent of Subjects Who Required 0, 1, 2, and 3 Airway Manipulations for the Placement of the Supraglottic Device
1 manipulations
|
10 percent of participants
|
13 percent of participants
|
|
Percent of Subjects Who Required 0, 1, 2, and 3 Airway Manipulations for the Placement of the Supraglottic Device
2 manipulations
|
5 percent of participants
|
7 percent of participants
|
|
Percent of Subjects Who Required 0, 1, 2, and 3 Airway Manipulations for the Placement of the Supraglottic Device
3 manipulations
|
5 percent of participants
|
0 percent of participants
|
SECONDARY outcome
Timeframe: Up to 10 minutesPopulation: unable to confirm accuracy of data in 1 participant in the I-gel group, that participant's data was not included in the analysis
This measure of time begins with the handling of the fiberscope to withdrawal of the fiberscope from the Aintree and setting the fiberscope down
Outcome measures
| Measure |
I-gel Supraglottic Device
n=19 Participants
The I-gel is an alternative supraglottic device made from thermoplastic elastomer which provides the seal over the airway versus an inflatable cuff.
I-gel supraglottic device: The fiberscope (with the Aintree loaded on top of it) will be advanced through the supraglottic device into the trachea. Next, the supraglottic device will be removed and the endotracheal tube will be advanced into the airway over the Aintree airway intubation catheter. Finally, the Aintree catheter is removed and the endotracheal tube will be left in the airway.
|
LMA-Supreme Supraglottic Device
n=19 Participants
The LMA-Supreme is a single-use disposable supraglottic airway that utilizes an inflatable cuff
LMA-Supreme supraglottic device: The fiberscope (with the Aintree loaded on top of it) will be advanced through the supraglottic device into the trachea. Next, the supraglottic device will be removed and the endotracheal tube will be advanced into the airway over the Aintree airway intubation catheter. Finally, the Aintree catheter is removed and the endotracheal tube will be left in the airway.
|
|---|---|---|
|
Time to Placement of the Aintree Airway Intubation Catheter
|
155 seconds
Standard Deviation 182
|
301 seconds
Standard Deviation 246
|
SECONDARY outcome
Timeframe: Up to 10 minutesPopulation: 2 participants in I-gel arm were excluded from analysis because times to established safety cutoff for airway establishment(10 minutes) was exceeded. 3 participants in LMA-Supreme arm were excluded in analysis because study was aborted at request of attending or times to established safety cutoff for airway establishment (10 minutes) was exceeded.
Percent of subjects who required 0, 1, 2, 3 and 6 airway manipulations for the placement of the Aintree.
Outcome measures
| Measure |
I-gel Supraglottic Device
n=18 Participants
The I-gel is an alternative supraglottic device made from thermoplastic elastomer which provides the seal over the airway versus an inflatable cuff.
I-gel supraglottic device: The fiberscope (with the Aintree loaded on top of it) will be advanced through the supraglottic device into the trachea. Next, the supraglottic device will be removed and the endotracheal tube will be advanced into the airway over the Aintree airway intubation catheter. Finally, the Aintree catheter is removed and the endotracheal tube will be left in the airway.
|
LMA-Supreme Supraglottic Device
n=16 Participants
The LMA-Supreme is a single-use disposable supraglottic airway that utilizes an inflatable cuff
LMA-Supreme supraglottic device: The fiberscope (with the Aintree loaded on top of it) will be advanced through the supraglottic device into the trachea. Next, the supraglottic device will be removed and the endotracheal tube will be advanced into the airway over the Aintree airway intubation catheter. Finally, the Aintree catheter is removed and the endotracheal tube will be left in the airway.
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|---|---|---|
|
Percent of Subjects Who Required 0, 1, 2, 3 and 6 Airway Manipulations for the Placement of the Aintree.
6 manipulations
|
0 percent of participants
|
6 percent of participants
|
|
Percent of Subjects Who Required 0, 1, 2, 3 and 6 Airway Manipulations for the Placement of the Aintree.
0 manipulations
|
67 percent of participants
|
25 percent of participants
|
|
Percent of Subjects Who Required 0, 1, 2, 3 and 6 Airway Manipulations for the Placement of the Aintree.
1 manipulations
|
33 percent of participants
|
25 percent of participants
|
|
Percent of Subjects Who Required 0, 1, 2, 3 and 6 Airway Manipulations for the Placement of the Aintree.
2 manipulations
|
0 percent of participants
|
31 percent of participants
|
|
Percent of Subjects Who Required 0, 1, 2, 3 and 6 Airway Manipulations for the Placement of the Aintree.
3 manipulations
|
0 percent of participants
|
12 percent of participants
|
SECONDARY outcome
Timeframe: Up to 10 minutesPopulation: unable to confirm accuracy of data in 1 participant in the I-gel group, that participant's data was not included in the analysis
Time to the appropriate placement of the endotracheal tube.
Outcome measures
| Measure |
I-gel Supraglottic Device
n=19 Participants
The I-gel is an alternative supraglottic device made from thermoplastic elastomer which provides the seal over the airway versus an inflatable cuff.
I-gel supraglottic device: The fiberscope (with the Aintree loaded on top of it) will be advanced through the supraglottic device into the trachea. Next, the supraglottic device will be removed and the endotracheal tube will be advanced into the airway over the Aintree airway intubation catheter. Finally, the Aintree catheter is removed and the endotracheal tube will be left in the airway.
|
LMA-Supreme Supraglottic Device
n=19 Participants
The LMA-Supreme is a single-use disposable supraglottic airway that utilizes an inflatable cuff
LMA-Supreme supraglottic device: The fiberscope (with the Aintree loaded on top of it) will be advanced through the supraglottic device into the trachea. Next, the supraglottic device will be removed and the endotracheal tube will be advanced into the airway over the Aintree airway intubation catheter. Finally, the Aintree catheter is removed and the endotracheal tube will be left in the airway.
|
|---|---|---|
|
Time to Placement of the Endotrotracheal Tube
|
81 second
Standard Deviation 71
|
96 second
Standard Deviation 117
|
SECONDARY outcome
Timeframe: Up to 10 minutesPopulation: 2 participants in I-gel arm were excluded from analysis because times to established safety cutoff for airway establishment(10 minutes) was exceeded. 5 participants in LMA-Supreme arm were excluded in analysis because study was aborted at request of attending or times to established safety cutoff for airway establishment (10 minutes) was exceeded.
Percent of subjects with 0, 1, 2 and 3 airway manipulations required for placement of endotrachial tube
Outcome measures
| Measure |
I-gel Supraglottic Device
n=18 Participants
The I-gel is an alternative supraglottic device made from thermoplastic elastomer which provides the seal over the airway versus an inflatable cuff.
I-gel supraglottic device: The fiberscope (with the Aintree loaded on top of it) will be advanced through the supraglottic device into the trachea. Next, the supraglottic device will be removed and the endotracheal tube will be advanced into the airway over the Aintree airway intubation catheter. Finally, the Aintree catheter is removed and the endotracheal tube will be left in the airway.
|
LMA-Supreme Supraglottic Device
n=14 Participants
The LMA-Supreme is a single-use disposable supraglottic airway that utilizes an inflatable cuff
LMA-Supreme supraglottic device: The fiberscope (with the Aintree loaded on top of it) will be advanced through the supraglottic device into the trachea. Next, the supraglottic device will be removed and the endotracheal tube will be advanced into the airway over the Aintree airway intubation catheter. Finally, the Aintree catheter is removed and the endotracheal tube will be left in the airway.
|
|---|---|---|
|
Percent of Subjects With 0, 1, 2 and 3 Airway Manipulations Required for Placement of Endotrachial Tube
0 manipulations
|
67 percent of participants
|
57 percent of participants
|
|
Percent of Subjects With 0, 1, 2 and 3 Airway Manipulations Required for Placement of Endotrachial Tube
1 manipulations
|
17 percent of participants
|
43 percent of participants
|
|
Percent of Subjects With 0, 1, 2 and 3 Airway Manipulations Required for Placement of Endotrachial Tube
2 manipulations
|
11 percent of participants
|
0 percent of participants
|
|
Percent of Subjects With 0, 1, 2 and 3 Airway Manipulations Required for Placement of Endotrachial Tube
3 manipulations
|
6 percent of participants
|
0 percent of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 10 minutesThe visualization of each of the following structures provides one point, for a maximum score of 7. 1. Right true vocal cord. 2. Left true vocal cord. 3. Right false vocal cord. 4. Left false vocal cord. 5. Right posterior cartilage 6. Left posterior cartilage 7. Epiglottis
Outcome measures
| Measure |
I-gel Supraglottic Device
n=20 Participants
The I-gel is an alternative supraglottic device made from thermoplastic elastomer which provides the seal over the airway versus an inflatable cuff.
I-gel supraglottic device: The fiberscope (with the Aintree loaded on top of it) will be advanced through the supraglottic device into the trachea. Next, the supraglottic device will be removed and the endotracheal tube will be advanced into the airway over the Aintree airway intubation catheter. Finally, the Aintree catheter is removed and the endotracheal tube will be left in the airway.
|
LMA-Supreme Supraglottic Device
n=19 Participants
The LMA-Supreme is a single-use disposable supraglottic airway that utilizes an inflatable cuff
LMA-Supreme supraglottic device: The fiberscope (with the Aintree loaded on top of it) will be advanced through the supraglottic device into the trachea. Next, the supraglottic device will be removed and the endotracheal tube will be advanced into the airway over the Aintree airway intubation catheter. Finally, the Aintree catheter is removed and the endotracheal tube will be left in the airway.
|
|---|---|---|
|
Visualization Score
|
6.0 units on a scale
Standard Deviation 1.3
|
3.4 units on a scale
Standard Deviation 2.9
|
Adverse Events
I-gel Supraglottic Device
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
LMA-Supreme Supraglottic Device
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
I-gel Supraglottic Device
n=20 participants at risk
The I-gel is an alternative supraglottic device made from thermoplastic elastomer which provides the seal over the airway versus an inflatable cuff.
I-gel supraglottic device: The fiberscope (with the Aintree loaded on top of it) will be advanced through the supraglottic device into the trachea. Next, the supraglottic device will be removed and the endotracheal tube will be advanced into the airway over the Aintree airway intubation catheter. Finally, the Aintree catheter is removed and the endotracheal tube will be left in the airway.
|
LMA-Supreme Supraglottic Device
n=19 participants at risk
The LMA-Supreme is a single-use disposable supraglottic airway that utilizes an inflatable cuff
LMA-Supreme supraglottic device: The fiberscope (with the Aintree loaded on top of it) will be advanced through the supraglottic device into the trachea. Next, the supraglottic device will be removed and the endotracheal tube will be advanced into the airway over the Aintree airway intubation catheter. Finally, the Aintree catheter is removed and the endotracheal tube will be left in the airway.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Coughing
|
5.0%
1/20 • Number of events 1 • from start of anesthesia to successful intubation, up to 10 minutes
|
0.00%
0/19 • from start of anesthesia to successful intubation, up to 10 minutes
|
|
Respiratory, thoracic and mediastinal disorders
Post Extubation Stridor
|
5.0%
1/20 • Number of events 1 • from start of anesthesia to successful intubation, up to 10 minutes
|
0.00%
0/19 • from start of anesthesia to successful intubation, up to 10 minutes
|
Additional Information
Antonio Hernandez, MD
Vanderbilt University Medical Center
Phone: 615 322-4650
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place