Trial Outcomes & Findings for Comparison Study of Two Supraglottic Airway Devices Used for Patients Under General Anesthesia (NCT NCT01001078)
NCT ID: NCT01001078
Last Updated: 2015-01-22
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
After introduction of the supraglottic device before the beginning of the surgery.
Results posted on
2015-01-22
Participant Flow
Recruitment was done at a university hospital mainly in the ambulatory surgery unit from september 2009 to april 2011. 50 patients were recruited in 2009, one fourth in 2010 and the last fourth in 2011. 311 patients were assessed for eligibility, 211 were excluded. 178 did not meet inclusion criteria and 33 declined to participate.
Participant milestones
| Measure |
I-Gel
Group in which the I-Gel will be used in the first and second attempts to secure the airway. If a third attempt is needed, the LMA Supreme will be used. If the third attempt fails, a standard endotracheal tube will be used.
Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured as well. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O.
|
LMA Supreme
Group in which the LMA Supreme will be used in the first and second attempts to secure the airway. If a third attempt is needed, the I-Gel will be used. If the third attempt fails, a standard endotracheal tube will be used.
The cuff of the LMA Supreme will be inflated with 25 mL of air and then by intervals of 5 mL until no leak is heard (max 45 mL). Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured at a cuff volume without audible leak and also at 45 mL. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O. Once the leak tests are done, the cuff will be deflated to initial volume necessary to avoid audible leaks.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
Received Allocated Intervention
|
46
|
46
|
|
Overall Study
Received Crossover
|
2
|
3
|
|
Overall Study
Intubated
|
2
|
1
|
|
Overall Study
Lost to Followup Interview
|
5
|
2
|
|
Overall Study
COMPLETED
|
50
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison Study of Two Supraglottic Airway Devices Used for Patients Under General Anesthesia
Baseline characteristics by cohort
| Measure |
I-Gel
n=50 Participants
Group in which the I-Gel will be used in the first and second attempts to secure the airway. If a third attempt is needed, the LMA Supreme will be used. If the third attempt fails, a standard endotracheal tube will be used.
Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured as well. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O.
|
LMA Supreme
n=50 Participants
Group in which the LMA Supreme will be used in the first and second attempts to secure the airway. If a third attempt is needed, the I-Gel will be used. If the third attempt fails, a standard endotracheal tube will be used.
The cuff of the LMA Supreme will be inflated with 25 mL of air and then by intervals of 5 mL until no leak is heard (max 45 mL). Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured at a cuff volume without audible leak and also at 45 mL. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O. Once the leak tests are done, the cuff will be deflated to initial volume necessary to avoid audible leaks.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50 years
STANDARD_DEVIATION 16 • n=5 Participants
|
50 years
STANDARD_DEVIATION 18 • n=7 Participants
|
50 years
STANDARD_DEVIATION 17 • n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Weight
|
72 kilograms
STANDARD_DEVIATION 11 • n=5 Participants
|
71 kilograms
STANDARD_DEVIATION 13 • n=7 Participants
|
71.5 kilograms
STANDARD_DEVIATION 12 • n=5 Participants
|
|
BMI
|
26 kg/m^2
STANDARD_DEVIATION 4 • n=5 Participants
|
26 kg/m^2
STANDARD_DEVIATION 4 • n=7 Participants
|
26 kg/m^2
STANDARD_DEVIATION 4 • n=5 Participants
|
|
Height
|
1.68 meters
STANDARD_DEVIATION 0.09 • n=5 Participants
|
1.67 meters
STANDARD_DEVIATION 0.10 • n=7 Participants
|
1.68 meters
STANDARD_DEVIATION 0.095 • n=5 Participants
|
PRIMARY outcome
Timeframe: After introduction of the supraglottic device before the beginning of the surgery.Outcome measures
| Measure |
I-Gel
n=46 Participants
Group in which the I-Gel will be used in the first and second attempts to secure the airway. If a third attempt is needed, the LMA Supreme will be used. If the third attempt fails, a standard endotracheal tube will be used.
Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured as well. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O.
|
LMA Supreme
n=46 Participants
Group in which the LMA Supreme will be used in the first and second attempts to secure the airway. If a third attempt is needed, the I-Gel will be used. If the third attempt fails, a standard endotracheal tube will be used.
The cuff of the LMA Supreme will be inflated with 25 mL of air and then by intervals of 5 mL until no leak is heard (max 45 mL). Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured at a cuff volume without audible leak and also at 45 mL. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O. Once the leak tests are done, the cuff will be deflated to initial volume necessary to avoid audible leaks.
|
|---|---|---|
|
Measure of the Airway Leak Pressure
|
23 cmH2O
Standard Deviation 7
|
21 cmH2O
Standard Deviation 8
|
SECONDARY outcome
Timeframe: After introduction of the SAD before the beginning of the surgery.Outcome measures
| Measure |
I-Gel
n=46 Participants
Group in which the I-Gel will be used in the first and second attempts to secure the airway. If a third attempt is needed, the LMA Supreme will be used. If the third attempt fails, a standard endotracheal tube will be used.
Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured as well. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O.
|
LMA Supreme
n=46 Participants
Group in which the LMA Supreme will be used in the first and second attempts to secure the airway. If a third attempt is needed, the I-Gel will be used. If the third attempt fails, a standard endotracheal tube will be used.
The cuff of the LMA Supreme will be inflated with 25 mL of air and then by intervals of 5 mL until no leak is heard (max 45 mL). Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured at a cuff volume without audible leak and also at 45 mL. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O. Once the leak tests are done, the cuff will be deflated to initial volume necessary to avoid audible leaks.
|
|---|---|---|
|
Measure of the Peak Airway Pressure
|
14 cm H20
Standard Deviation 3
|
14 cm H20
Standard Deviation 5
|
SECONDARY outcome
Timeframe: From opening of the mouth to thoracic expansion and presence of End Tidal CO2 up to five minutes.Outcome measures
| Measure |
I-Gel
n=46 Participants
Group in which the I-Gel will be used in the first and second attempts to secure the airway. If a third attempt is needed, the LMA Supreme will be used. If the third attempt fails, a standard endotracheal tube will be used.
Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured as well. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O.
|
LMA Supreme
n=46 Participants
Group in which the LMA Supreme will be used in the first and second attempts to secure the airway. If a third attempt is needed, the I-Gel will be used. If the third attempt fails, a standard endotracheal tube will be used.
The cuff of the LMA Supreme will be inflated with 25 mL of air and then by intervals of 5 mL until no leak is heard (max 45 mL). Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured at a cuff volume without audible leak and also at 45 mL. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O. Once the leak tests are done, the cuff will be deflated to initial volume necessary to avoid audible leaks.
|
|---|---|---|
|
Time Needed to Secure the Airway
|
19 seconds
Standard Deviation 7
|
27 seconds
Standard Deviation 17
|
SECONDARY outcome
Timeframe: At the beginning of anesthesia before the beginning of the surgery.Outcome measures
| Measure |
I-Gel
n=50 Participants
Group in which the I-Gel will be used in the first and second attempts to secure the airway. If a third attempt is needed, the LMA Supreme will be used. If the third attempt fails, a standard endotracheal tube will be used.
Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured as well. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O.
|
LMA Supreme
n=50 Participants
Group in which the LMA Supreme will be used in the first and second attempts to secure the airway. If a third attempt is needed, the I-Gel will be used. If the third attempt fails, a standard endotracheal tube will be used.
The cuff of the LMA Supreme will be inflated with 25 mL of air and then by intervals of 5 mL until no leak is heard (max 45 mL). Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured at a cuff volume without audible leak and also at 45 mL. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O. Once the leak tests are done, the cuff will be deflated to initial volume necessary to avoid audible leaks.
|
|---|---|---|
|
Number of Participants With Successful Attempts to Introduce the Devices
1st attempt successful
|
43 participants
|
44 participants
|
|
Number of Participants With Successful Attempts to Introduce the Devices
2nd attempt successful
|
3 participants
|
2 participants
|
|
Number of Participants With Successful Attempts to Introduce the Devices
Crossover device
|
2 participants
|
3 participants
|
|
Number of Participants With Successful Attempts to Introduce the Devices
Intubation
|
2 participants
|
1 participants
|
SECONDARY outcome
Timeframe: On the day following surgeryPopulation: 5 participants were lost to follow-up and 4 participants had the crossover device or were intubated in the I-Gel group. 4 participants were lost to follow-up and 3 participants had the crossover device or were intubated in the LMA Supreme group (one of participants was lost to follow-up and had the crossover device or was intubated)
Intent to treat assessment of adverse events, per intervention, was intended. The adverse effects were assessed by phone; or in person if patient in the hospital; on the following day.
Outcome measures
| Measure |
I-Gel
n=41 Participants
Group in which the I-Gel will be used in the first and second attempts to secure the airway. If a third attempt is needed, the LMA Supreme will be used. If the third attempt fails, a standard endotracheal tube will be used.
Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured as well. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O.
|
LMA Supreme
n=44 Participants
Group in which the LMA Supreme will be used in the first and second attempts to secure the airway. If a third attempt is needed, the I-Gel will be used. If the third attempt fails, a standard endotracheal tube will be used.
The cuff of the LMA Supreme will be inflated with 25 mL of air and then by intervals of 5 mL until no leak is heard (max 45 mL). Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured at a cuff volume without audible leak and also at 45 mL. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O. Once the leak tests are done, the cuff will be deflated to initial volume necessary to avoid audible leaks.
|
|---|---|---|
|
Adverse Effects After Anesthesia (Sore Throat, Cough, Dysphagia, Dysphonia)
Sore Throat (absent)
|
23 participants
|
26 participants
|
|
Adverse Effects After Anesthesia (Sore Throat, Cough, Dysphagia, Dysphonia)
Sore Throat (mild)
|
10 participants
|
13 participants
|
|
Adverse Effects After Anesthesia (Sore Throat, Cough, Dysphagia, Dysphonia)
Sore Throat (moderate)
|
6 participants
|
4 participants
|
|
Adverse Effects After Anesthesia (Sore Throat, Cough, Dysphagia, Dysphonia)
Sore Throat (severe)
|
2 participants
|
1 participants
|
|
Adverse Effects After Anesthesia (Sore Throat, Cough, Dysphagia, Dysphonia)
Cough (absent)
|
36 participants
|
38 participants
|
|
Adverse Effects After Anesthesia (Sore Throat, Cough, Dysphagia, Dysphonia)
Cough (mild)
|
5 participants
|
5 participants
|
|
Adverse Effects After Anesthesia (Sore Throat, Cough, Dysphagia, Dysphonia)
Cough (moderate)
|
0 participants
|
1 participants
|
|
Adverse Effects After Anesthesia (Sore Throat, Cough, Dysphagia, Dysphonia)
Cough (severe)
|
0 participants
|
0 participants
|
|
Adverse Effects After Anesthesia (Sore Throat, Cough, Dysphagia, Dysphonia)
Dysphagia (absent)
|
25 participants
|
29 participants
|
|
Adverse Effects After Anesthesia (Sore Throat, Cough, Dysphagia, Dysphonia)
Dysphagia (mild)
|
7 participants
|
9 participants
|
|
Adverse Effects After Anesthesia (Sore Throat, Cough, Dysphagia, Dysphonia)
Dysphagia (moderate)
|
9 participants
|
4 participants
|
|
Adverse Effects After Anesthesia (Sore Throat, Cough, Dysphagia, Dysphonia)
Dysphagia (severe)
|
0 participants
|
2 participants
|
|
Adverse Effects After Anesthesia (Sore Throat, Cough, Dysphagia, Dysphonia)
Dysphonia (absent)
|
34 participants
|
35 participants
|
|
Adverse Effects After Anesthesia (Sore Throat, Cough, Dysphagia, Dysphonia)
Dysphonia (mild)
|
5 participants
|
5 participants
|
|
Adverse Effects After Anesthesia (Sore Throat, Cough, Dysphagia, Dysphonia)
Dysphonia (moderate)
|
1 participants
|
3 participants
|
|
Adverse Effects After Anesthesia (Sore Throat, Cough, Dysphagia, Dysphonia)
Dysphonia (severe)
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: During and after anesthesia when the device is removed.Outcome measures
| Measure |
I-Gel
n=46 Participants
Group in which the I-Gel will be used in the first and second attempts to secure the airway. If a third attempt is needed, the LMA Supreme will be used. If the third attempt fails, a standard endotracheal tube will be used.
Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured as well. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O.
|
LMA Supreme
n=46 Participants
Group in which the LMA Supreme will be used in the first and second attempts to secure the airway. If a third attempt is needed, the I-Gel will be used. If the third attempt fails, a standard endotracheal tube will be used.
The cuff of the LMA Supreme will be inflated with 25 mL of air and then by intervals of 5 mL until no leak is heard (max 45 mL). Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured at a cuff volume without audible leak and also at 45 mL. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O. Once the leak tests are done, the cuff will be deflated to initial volume necessary to avoid audible leaks.
|
|---|---|---|
|
Airway Manipulation and Blood on Device at Removal
Repositionning during surgery
|
2 participants
|
3 participants
|
|
Airway Manipulation and Blood on Device at Removal
Blood on device at removal
|
5 participants
|
6 participants
|
Adverse Events
I-Gel
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
LMA Supreme
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
I-Gel
n=50 participants at risk
Group in which the I-Gel will be used in the first and second attempts to secure the airway. If a third attempt is needed, the LMA Supreme will be used. If the third attempt fails, a standard endotracheal tube will be used.
Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured as well. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O.
|
LMA Supreme
n=50 participants at risk
Group in which the LMA Supreme will be used in the first and second attempts to secure the airway. If a third attempt is needed, the I-Gel will be used. If the third attempt fails, a standard endotracheal tube will be used.
The cuff of the LMA Supreme will be inflated with 25 mL of air and then by intervals of 5 mL until no leak is heard (max 45 mL). Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured at a cuff volume without audible leak and also at 45 mL. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O. Once the leak tests are done, the cuff will be deflated to initial volume necessary to avoid audible leaks.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
severe sore throat
|
4.0%
2/50 • Number of events 2 • 24 hour after placement of the device
|
2.0%
1/50 • Number of events 1 • 24 hour after placement of the device
|
|
Respiratory, thoracic and mediastinal disorders
severe cough
|
0.00%
0/50 • 24 hour after placement of the device
|
0.00%
0/50 • 24 hour after placement of the device
|
|
Gastrointestinal disorders
severe dysphagia
|
0.00%
0/50 • 24 hour after placement of the device
|
4.0%
2/50 • Number of events 2 • 24 hour after placement of the device
|
|
Respiratory, thoracic and mediastinal disorders
severe dysphonia
|
2.0%
1/50 • Number of events 1 • 24 hour after placement of the device
|
2.0%
1/50 • Number of events 1 • 24 hour after placement of the device
|
|
Respiratory, thoracic and mediastinal disorders
mild sore throat
|
20.0%
10/50 • Number of events 10 • 24 hour after placement of the device
|
26.0%
13/50 • Number of events 13 • 24 hour after placement of the device
|
|
Respiratory, thoracic and mediastinal disorders
moderate sore throat
|
12.0%
6/50 • Number of events 6 • 24 hour after placement of the device
|
8.0%
4/50 • Number of events 4 • 24 hour after placement of the device
|
|
Gastrointestinal disorders
mild dysphagia
|
14.0%
7/50 • Number of events 7 • 24 hour after placement of the device
|
18.0%
9/50 • Number of events 9 • 24 hour after placement of the device
|
|
Gastrointestinal disorders
moderate dysphagia
|
18.0%
9/50 • Number of events 9 • 24 hour after placement of the device
|
8.0%
4/50 • Number of events 4 • 24 hour after placement of the device
|
|
Respiratory, thoracic and mediastinal disorders
mild dysphonia
|
10.0%
5/50 • Number of events 5 • 24 hour after placement of the device
|
10.0%
5/50 • Number of events 5 • 24 hour after placement of the device
|
|
Respiratory, thoracic and mediastinal disorders
moderate dysphonia
|
2.0%
1/50 • Number of events 1 • 24 hour after placement of the device
|
6.0%
3/50 • Number of events 3 • 24 hour after placement of the device
|
|
Respiratory, thoracic and mediastinal disorders
mild cough
|
10.0%
5/50 • Number of events 5 • 24 hour after placement of the device
|
10.0%
5/50 • Number of events 5 • 24 hour after placement of the device
|
|
Respiratory, thoracic and mediastinal disorders
moderate cough
|
0.00%
0/50 • 24 hour after placement of the device
|
2.0%
1/50 • Number of events 1 • 24 hour after placement of the device
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place