Trial Outcomes & Findings for A New Insertion Technique for Laryngeal Mask Airway (NCT NCT01749033)
NCT ID: NCT01749033
Last Updated: 2019-12-17
Results Overview
The primary outcomes for this study will be postoperative pharyngolaryngeal complications of sore throat as reported by the participant.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
450 participants
Primary outcome timeframe
24 hours
Results posted on
2019-12-17
Participant Flow
Participant milestones
| Measure |
Group 1 Classic
Group 1 Using the classic inserting technique and completely deflated LMA recommended in the LMA manual.
Group 1 Classic: Active Comparator: Group 1 classic
Group 1 Using the classic inserting technique and completely deflated LMA recommended in the LMA manual.
|
Group 2 Pre Inflated
Group 2 (pre-inflated): Using the recommended inserting technique with the pre-inflated volume that exists in a LMA from the manufacturer
Group 2 pre-inflated: Group 2 (pre-inflated): Using the recommended inserting technique with the pre-inflated volume that exists in a LMA from the manufacturer.
|
Group 3 ELL-PIC Technique
Group 3 (ELL-PIC): Using the ELL-PIC technique.
Group 3 ELL-PIC: Group 3 (ELL-PIC): Using the ELL-PIC technique
|
|---|---|---|---|
|
Overall Study
STARTED
|
150
|
150
|
150
|
|
Overall Study
COMPLETED
|
147
|
145
|
149
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
1
|
Reasons for withdrawal
| Measure |
Group 1 Classic
Group 1 Using the classic inserting technique and completely deflated LMA recommended in the LMA manual.
Group 1 Classic: Active Comparator: Group 1 classic
Group 1 Using the classic inserting technique and completely deflated LMA recommended in the LMA manual.
|
Group 2 Pre Inflated
Group 2 (pre-inflated): Using the recommended inserting technique with the pre-inflated volume that exists in a LMA from the manufacturer
Group 2 pre-inflated: Group 2 (pre-inflated): Using the recommended inserting technique with the pre-inflated volume that exists in a LMA from the manufacturer.
|
Group 3 ELL-PIC Technique
Group 3 (ELL-PIC): Using the ELL-PIC technique.
Group 3 ELL-PIC: Group 3 (ELL-PIC): Using the ELL-PIC technique
|
|---|---|---|---|
|
Overall Study
Did not receive allocated intervention
|
3
|
3
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
1
|
Baseline Characteristics
Some subjects were dropped from the study lost to follow up or the anesthetic management plan changed during the surgical procedure.
Baseline characteristics by cohort
| Measure |
Group 1 Classic
n=150 Participants
Group 1 Using the classic inserting technique and completely deflated LMA recommended in the LMA manual.
Group 1 Classic: Active Comparator: Group 1 classic
Group 1 Using the classic inserting technique and completely deflated LMA recommended in the LMA manual.
|
Group 2 Pre Inflated
n=150 Participants
Group 2 (pre-inflated): Using the recommended inserting technique with the pre-inflated volume that exists in a LMA from the manufacturer
Group 2 pre-inflated: Group 2 (pre-inflated): Using the recommended inserting technique with the pre-inflated volume that exists in a LMA from the manufacturer.
|
Group 3 ELL-PIC Technique
n=150 Participants
Group 3 (ELL-PIC): Using the ELL-PIC technique.
Group 3 ELL-PIC: Group 3 (ELL-PIC): Using the ELL-PIC technique
|
Total
n=450 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=147 Participants • Some subjects were dropped from the study lost to follow up or the anesthetic management plan changed during the surgical procedure.
|
0 Participants
n=145 Participants • Some subjects were dropped from the study lost to follow up or the anesthetic management plan changed during the surgical procedure.
|
0 Participants
n=149 Participants • Some subjects were dropped from the study lost to follow up or the anesthetic management plan changed during the surgical procedure.
|
0 Participants
n=441 Participants • Some subjects were dropped from the study lost to follow up or the anesthetic management plan changed during the surgical procedure.
|
|
Age, Categorical
Between 18 and 65 years
|
147 Participants
n=147 Participants • Some subjects were dropped from the study lost to follow up or the anesthetic management plan changed during the surgical procedure.
|
145 Participants
n=145 Participants • Some subjects were dropped from the study lost to follow up or the anesthetic management plan changed during the surgical procedure.
|
149 Participants
n=149 Participants • Some subjects were dropped from the study lost to follow up or the anesthetic management plan changed during the surgical procedure.
|
441 Participants
n=441 Participants • Some subjects were dropped from the study lost to follow up or the anesthetic management plan changed during the surgical procedure.
|
|
Age, Categorical
>=65 years
|
0 Participants
n=147 Participants • Some subjects were dropped from the study lost to follow up or the anesthetic management plan changed during the surgical procedure.
|
0 Participants
n=145 Participants • Some subjects were dropped from the study lost to follow up or the anesthetic management plan changed during the surgical procedure.
|
0 Participants
n=149 Participants • Some subjects were dropped from the study lost to follow up or the anesthetic management plan changed during the surgical procedure.
|
0 Participants
n=441 Participants • Some subjects were dropped from the study lost to follow up or the anesthetic management plan changed during the surgical procedure.
|
|
Age, Continuous
|
45 years
STANDARD_DEVIATION 16 • n=147 Participants • Some subjects were dropped from the study lost to follow up or the anesthetic management plan changed during the surgical procedure.
|
47 years
STANDARD_DEVIATION 16 • n=145 Participants • Some subjects were dropped from the study lost to follow up or the anesthetic management plan changed during the surgical procedure.
|
46 years
STANDARD_DEVIATION 16 • n=149 Participants • Some subjects were dropped from the study lost to follow up or the anesthetic management plan changed during the surgical procedure.
|
46 years
STANDARD_DEVIATION 16 • n=441 Participants • Some subjects were dropped from the study lost to follow up or the anesthetic management plan changed during the surgical procedure.
|
|
Sex: Female, Male
Female
|
58 Participants
n=147 Participants • Subject number is different because of dropout, lost to follow up or changed anesthetic care.
|
60 Participants
n=145 Participants • Subject number is different because of dropout, lost to follow up or changed anesthetic care.
|
67 Participants
n=149 Participants • Subject number is different because of dropout, lost to follow up or changed anesthetic care.
|
185 Participants
n=441 Participants • Subject number is different because of dropout, lost to follow up or changed anesthetic care.
|
|
Sex: Female, Male
Male
|
89 Participants
n=147 Participants • Subject number is different because of dropout, lost to follow up or changed anesthetic care.
|
85 Participants
n=145 Participants • Subject number is different because of dropout, lost to follow up or changed anesthetic care.
|
82 Participants
n=149 Participants • Subject number is different because of dropout, lost to follow up or changed anesthetic care.
|
256 Participants
n=441 Participants • Subject number is different because of dropout, lost to follow up or changed anesthetic care.
|
|
Region of Enrollment
United States
|
147 participants
n=147 Participants • Some subjects were dropped from the study lost to follow up or the anesthetic management plan changed during the surgical procedure.
|
145 participants
n=145 Participants • Some subjects were dropped from the study lost to follow up or the anesthetic management plan changed during the surgical procedure.
|
149 participants
n=149 Participants • Some subjects were dropped from the study lost to follow up or the anesthetic management plan changed during the surgical procedure.
|
450 participants
n=441 Participants • Some subjects were dropped from the study lost to follow up or the anesthetic management plan changed during the surgical procedure.
|
|
OMA Insertion attempts
1 attempt
|
122 Participants
n=147 Participants • The (N) analyzed is lower because of drop outs and change in anesthesic method during the case.
|
126 Participants
n=145 Participants • The (N) analyzed is lower because of drop outs and change in anesthesic method during the case.
|
136 Participants
n=149 Participants • The (N) analyzed is lower because of drop outs and change in anesthesic method during the case.
|
384 Participants
n=441 Participants • The (N) analyzed is lower because of drop outs and change in anesthesic method during the case.
|
|
OMA Insertion attempts
2 attempts
|
21 Participants
n=147 Participants • The (N) analyzed is lower because of drop outs and change in anesthesic method during the case.
|
16 Participants
n=145 Participants • The (N) analyzed is lower because of drop outs and change in anesthesic method during the case.
|
12 Participants
n=149 Participants • The (N) analyzed is lower because of drop outs and change in anesthesic method during the case.
|
49 Participants
n=441 Participants • The (N) analyzed is lower because of drop outs and change in anesthesic method during the case.
|
|
OMA Insertion attempts
3 attempts
|
3 Participants
n=147 Participants • The (N) analyzed is lower because of drop outs and change in anesthesic method during the case.
|
3 Participants
n=145 Participants • The (N) analyzed is lower because of drop outs and change in anesthesic method during the case.
|
1 Participants
n=149 Participants • The (N) analyzed is lower because of drop outs and change in anesthesic method during the case.
|
7 Participants
n=441 Participants • The (N) analyzed is lower because of drop outs and change in anesthesic method during the case.
|
|
OMA Insertion attempts
4 attempts
|
1 Participants
n=147 Participants • The (N) analyzed is lower because of drop outs and change in anesthesic method during the case.
|
0 Participants
n=145 Participants • The (N) analyzed is lower because of drop outs and change in anesthesic method during the case.
|
0 Participants
n=149 Participants • The (N) analyzed is lower because of drop outs and change in anesthesic method during the case.
|
1 Participants
n=441 Participants • The (N) analyzed is lower because of drop outs and change in anesthesic method during the case.
|
|
OSA insertion time in seconds
|
54 Seconds
n=147 Participants • Subjects were lost to follow up or the anesthetic care changed during the surgical procedure.
|
54 Seconds
n=145 Participants • Subjects were lost to follow up or the anesthetic care changed during the surgical procedure.
|
56 Seconds
n=149 Participants • Subjects were lost to follow up or the anesthetic care changed during the surgical procedure.
|
55 Seconds
n=441 Participants • Subjects were lost to follow up or the anesthetic care changed during the surgical procedure.
|
|
Duration of OMA device
|
71 minutes
n=147 Participants • Subjects were lost to follow up or anesthetic management technique changed.
|
65 minutes
n=145 Participants • Subjects were lost to follow up or anesthetic management technique changed.
|
62 minutes
n=149 Participants • Subjects were lost to follow up or anesthetic management technique changed.
|
66 minutes
n=441 Participants • Subjects were lost to follow up or anesthetic management technique changed.
|
|
BMI (kg/m∧2 )
|
27.4 BMI (kg/m∧2 )
STANDARD_DEVIATION 5.2 • n=147 Participants • Subjects lost to follow up or required a different anesthetic regimen during the surgical procedure.
|
27.7 BMI (kg/m∧2 )
STANDARD_DEVIATION 5.8 • n=145 Participants • Subjects lost to follow up or required a different anesthetic regimen during the surgical procedure.
|
27.8 BMI (kg/m∧2 )
STANDARD_DEVIATION 5.5 • n=149 Participants • Subjects lost to follow up or required a different anesthetic regimen during the surgical procedure.
|
27.7 BMI (kg/m∧2 )
STANDARD_DEVIATION 5.6 • n=441 Participants • Subjects lost to follow up or required a different anesthetic regimen during the surgical procedure.
|
|
Neck Circumference (cm)
|
38 centimeters
n=147 Participants • Some subjects may be have been lost to followup or there was a change in anesthetic care during the surgical procedure.
|
38 centimeters
n=145 Participants • Some subjects may be have been lost to followup or there was a change in anesthetic care during the surgical procedure.
|
38 centimeters
n=149 Participants • Some subjects may be have been lost to followup or there was a change in anesthetic care during the surgical procedure.
|
38 centimeters
n=441 Participants • Some subjects may be have been lost to followup or there was a change in anesthetic care during the surgical procedure.
|
|
Mallampati Class
Class I
|
69 participants
n=147 Participants • Some participants may have been lost to follow up, dropped out or there was a change in anesthetic technique during the surgical procedure
|
60 participants
n=145 Participants • Some participants may have been lost to follow up, dropped out or there was a change in anesthetic technique during the surgical procedure
|
64 participants
n=149 Participants • Some participants may have been lost to follow up, dropped out or there was a change in anesthetic technique during the surgical procedure
|
193 participants
n=441 Participants • Some participants may have been lost to follow up, dropped out or there was a change in anesthetic technique during the surgical procedure
|
|
Mallampati Class
Class II
|
39 participants
n=147 Participants • Some participants may have been lost to follow up, dropped out or there was a change in anesthetic technique during the surgical procedure
|
52 participants
n=145 Participants • Some participants may have been lost to follow up, dropped out or there was a change in anesthetic technique during the surgical procedure
|
49 participants
n=149 Participants • Some participants may have been lost to follow up, dropped out or there was a change in anesthetic technique during the surgical procedure
|
140 participants
n=441 Participants • Some participants may have been lost to follow up, dropped out or there was a change in anesthetic technique during the surgical procedure
|
|
Mallampati Class
Class III
|
20 participants
n=147 Participants • Some participants may have been lost to follow up, dropped out or there was a change in anesthetic technique during the surgical procedure
|
20 participants
n=145 Participants • Some participants may have been lost to follow up, dropped out or there was a change in anesthetic technique during the surgical procedure
|
24 participants
n=149 Participants • Some participants may have been lost to follow up, dropped out or there was a change in anesthetic technique during the surgical procedure
|
64 participants
n=441 Participants • Some participants may have been lost to follow up, dropped out or there was a change in anesthetic technique during the surgical procedure
|
|
Mallampati Class
Class IV
|
19 participants
n=147 Participants • Some participants may have been lost to follow up, dropped out or there was a change in anesthetic technique during the surgical procedure
|
13 participants
n=145 Participants • Some participants may have been lost to follow up, dropped out or there was a change in anesthetic technique during the surgical procedure
|
12 participants
n=149 Participants • Some participants may have been lost to follow up, dropped out or there was a change in anesthetic technique during the surgical procedure
|
44 participants
n=441 Participants • Some participants may have been lost to follow up, dropped out or there was a change in anesthetic technique during the surgical procedure
|
|
ASA physical status
ASA l
|
74 ASA STATUS
n=147 Participants • Subject lost to follow up, drop out or there was a change in the anesthetic technique during the surgical procedure.
|
70 ASA STATUS
n=145 Participants • Subject lost to follow up, drop out or there was a change in the anesthetic technique during the surgical procedure.
|
70 ASA STATUS
n=149 Participants • Subject lost to follow up, drop out or there was a change in the anesthetic technique during the surgical procedure.
|
214 ASA STATUS
n=441 Participants • Subject lost to follow up, drop out or there was a change in the anesthetic technique during the surgical procedure.
|
|
ASA physical status
ASA ll
|
67 ASA STATUS
n=147 Participants • Subject lost to follow up, drop out or there was a change in the anesthetic technique during the surgical procedure.
|
69 ASA STATUS
n=145 Participants • Subject lost to follow up, drop out or there was a change in the anesthetic technique during the surgical procedure.
|
76 ASA STATUS
n=149 Participants • Subject lost to follow up, drop out or there was a change in the anesthetic technique during the surgical procedure.
|
212 ASA STATUS
n=441 Participants • Subject lost to follow up, drop out or there was a change in the anesthetic technique during the surgical procedure.
|
|
ASA physical status
ASA lll
|
4 ASA STATUS
n=147 Participants • Subject lost to follow up, drop out or there was a change in the anesthetic technique during the surgical procedure.
|
4 ASA STATUS
n=145 Participants • Subject lost to follow up, drop out or there was a change in the anesthetic technique during the surgical procedure.
|
3 ASA STATUS
n=149 Participants • Subject lost to follow up, drop out or there was a change in the anesthetic technique during the surgical procedure.
|
11 ASA STATUS
n=441 Participants • Subject lost to follow up, drop out or there was a change in the anesthetic technique during the surgical procedure.
|
|
ASA physical status
Not documented
|
2 ASA STATUS
n=147 Participants • Subject lost to follow up, drop out or there was a change in the anesthetic technique during the surgical procedure.
|
2 ASA STATUS
n=145 Participants • Subject lost to follow up, drop out or there was a change in the anesthetic technique during the surgical procedure.
|
0 ASA STATUS
n=149 Participants • Subject lost to follow up, drop out or there was a change in the anesthetic technique during the surgical procedure.
|
4 ASA STATUS
n=441 Participants • Subject lost to follow up, drop out or there was a change in the anesthetic technique during the surgical procedure.
|
|
Surgical Procedure Performed
Knee Arthroscopy
|
95 participants
n=147 Participants • Some subjects dropped out. Some of the planned anesthetic techniques were changed during the surgical procedure.
|
85 participants
n=145 Participants • Some subjects dropped out. Some of the planned anesthetic techniques were changed during the surgical procedure.
|
93 participants
n=149 Participants • Some subjects dropped out. Some of the planned anesthetic techniques were changed during the surgical procedure.
|
273 participants
n=441 Participants • Some subjects dropped out. Some of the planned anesthetic techniques were changed during the surgical procedure.
|
|
Surgical Procedure Performed
Shoulder Arthroscopy
|
29 participants
n=147 Participants • Some subjects dropped out. Some of the planned anesthetic techniques were changed during the surgical procedure.
|
42 participants
n=145 Participants • Some subjects dropped out. Some of the planned anesthetic techniques were changed during the surgical procedure.
|
41 participants
n=149 Participants • Some subjects dropped out. Some of the planned anesthetic techniques were changed during the surgical procedure.
|
112 participants
n=441 Participants • Some subjects dropped out. Some of the planned anesthetic techniques were changed during the surgical procedure.
|
|
Surgical Procedure Performed
Elbow Artrhroscopy
|
8 participants
n=147 Participants • Some subjects dropped out. Some of the planned anesthetic techniques were changed during the surgical procedure.
|
6 participants
n=145 Participants • Some subjects dropped out. Some of the planned anesthetic techniques were changed during the surgical procedure.
|
5 participants
n=149 Participants • Some subjects dropped out. Some of the planned anesthetic techniques were changed during the surgical procedure.
|
19 participants
n=441 Participants • Some subjects dropped out. Some of the planned anesthetic techniques were changed during the surgical procedure.
|
|
Surgical Procedure Performed
Other Arthroscopy
|
7 participants
n=147 Participants • Some subjects dropped out. Some of the planned anesthetic techniques were changed during the surgical procedure.
|
3 participants
n=145 Participants • Some subjects dropped out. Some of the planned anesthetic techniques were changed during the surgical procedure.
|
1 participants
n=149 Participants • Some subjects dropped out. Some of the planned anesthetic techniques were changed during the surgical procedure.
|
11 participants
n=441 Participants • Some subjects dropped out. Some of the planned anesthetic techniques were changed during the surgical procedure.
|
|
Surgical Procedure Performed
Breast and skin
|
2 participants
n=147 Participants • Some subjects dropped out. Some of the planned anesthetic techniques were changed during the surgical procedure.
|
4 participants
n=145 Participants • Some subjects dropped out. Some of the planned anesthetic techniques were changed during the surgical procedure.
|
4 participants
n=149 Participants • Some subjects dropped out. Some of the planned anesthetic techniques were changed during the surgical procedure.
|
10 participants
n=441 Participants • Some subjects dropped out. Some of the planned anesthetic techniques were changed during the surgical procedure.
|
|
Surgical Procedure Performed
Hernia Repair
|
3 participants
n=147 Participants • Some subjects dropped out. Some of the planned anesthetic techniques were changed during the surgical procedure.
|
1 participants
n=145 Participants • Some subjects dropped out. Some of the planned anesthetic techniques were changed during the surgical procedure.
|
3 participants
n=149 Participants • Some subjects dropped out. Some of the planned anesthetic techniques were changed during the surgical procedure.
|
7 participants
n=441 Participants • Some subjects dropped out. Some of the planned anesthetic techniques were changed during the surgical procedure.
|
|
Surgical Procedure Performed
Procedure of the eye
|
3 participants
n=147 Participants • Some subjects dropped out. Some of the planned anesthetic techniques were changed during the surgical procedure.
|
3 participants
n=145 Participants • Some subjects dropped out. Some of the planned anesthetic techniques were changed during the surgical procedure.
|
2 participants
n=149 Participants • Some subjects dropped out. Some of the planned anesthetic techniques were changed during the surgical procedure.
|
8 participants
n=441 Participants • Some subjects dropped out. Some of the planned anesthetic techniques were changed during the surgical procedure.
|
|
Surgical Procedure Performed
Other
|
0 participants
n=147 Participants • Some subjects dropped out. Some of the planned anesthetic techniques were changed during the surgical procedure.
|
1 participants
n=145 Participants • Some subjects dropped out. Some of the planned anesthetic techniques were changed during the surgical procedure.
|
0 participants
n=149 Participants • Some subjects dropped out. Some of the planned anesthetic techniques were changed during the surgical procedure.
|
1 participants
n=441 Participants • Some subjects dropped out. Some of the planned anesthetic techniques were changed during the surgical procedure.
|
|
Perioperative opioid use
Intraoperative opioid (morEq milligrams)
|
10 morphine equivalents milligrams
n=147 Participants • Some subjects dropped out. Some anesthetic techniques were changed during the surgical procedure.
|
10 morphine equivalents milligrams
n=145 Participants • Some subjects dropped out. Some anesthetic techniques were changed during the surgical procedure.
|
10 morphine equivalents milligrams
n=149 Participants • Some subjects dropped out. Some anesthetic techniques were changed during the surgical procedure.
|
10 morphine equivalents milligrams
n=441 Participants • Some subjects dropped out. Some anesthetic techniques were changed during the surgical procedure.
|
|
Perioperative opioid use
Postoperative opioid (morEq milligrams))
|
2.7 morphine equivalents milligrams
n=147 Participants • Some subjects dropped out. Some anesthetic techniques were changed during the surgical procedure.
|
1.3 morphine equivalents milligrams
n=145 Participants • Some subjects dropped out. Some anesthetic techniques were changed during the surgical procedure.
|
1.4 morphine equivalents milligrams
n=149 Participants • Some subjects dropped out. Some anesthetic techniques were changed during the surgical procedure.
|
1.4 morphine equivalents milligrams
n=441 Participants • Some subjects dropped out. Some anesthetic techniques were changed during the surgical procedure.
|
|
Perioperative opioid use
Total opioid (morEq milligrams)
|
15 morphine equivalents milligrams
n=147 Participants • Some subjects dropped out. Some anesthetic techniques were changed during the surgical procedure.
|
13 morphine equivalents milligrams
n=145 Participants • Some subjects dropped out. Some anesthetic techniques were changed during the surgical procedure.
|
13 morphine equivalents milligrams
n=149 Participants • Some subjects dropped out. Some anesthetic techniques were changed during the surgical procedure.
|
13 morphine equivalents milligrams
n=441 Participants • Some subjects dropped out. Some anesthetic techniques were changed during the surgical procedure.
|
|
Time to discharge
Phase 1 immediate PACU (minutes)
|
67 minutes
n=147 Participants • Some subjects were dropped from the study lost to follow up or the anesthetic management plan changed during the surgical procedure.
|
63 minutes
n=145 Participants • Some subjects were dropped from the study lost to follow up or the anesthetic management plan changed during the surgical procedure.
|
60 minutes
n=149 Participants • Some subjects were dropped from the study lost to follow up or the anesthetic management plan changed during the surgical procedure.
|
63 minutes
n=441 Participants • Some subjects were dropped from the study lost to follow up or the anesthetic management plan changed during the surgical procedure.
|
|
Time to discharge
Phase 2 PACU transition home (minutes)
|
90 minutes
n=147 Participants • Some subjects were dropped from the study lost to follow up or the anesthetic management plan changed during the surgical procedure.
|
95 minutes
n=145 Participants • Some subjects were dropped from the study lost to follow up or the anesthetic management plan changed during the surgical procedure.
|
95 minutes
n=149 Participants • Some subjects were dropped from the study lost to follow up or the anesthetic management plan changed during the surgical procedure.
|
93 minutes
n=441 Participants • Some subjects were dropped from the study lost to follow up or the anesthetic management plan changed during the surgical procedure.
|
|
Time to discharge
Time to discharge (minutes)
|
240 minutes
n=147 Participants • Some subjects were dropped from the study lost to follow up or the anesthetic management plan changed during the surgical procedure.
|
236 minutes
n=145 Participants • Some subjects were dropped from the study lost to follow up or the anesthetic management plan changed during the surgical procedure.
|
221 minutes
n=149 Participants • Some subjects were dropped from the study lost to follow up or the anesthetic management plan changed during the surgical procedure.
|
233 minutes
n=441 Participants • Some subjects were dropped from the study lost to follow up or the anesthetic management plan changed during the surgical procedure.
|
PRIMARY outcome
Timeframe: 24 hoursThe primary outcomes for this study will be postoperative pharyngolaryngeal complications of sore throat as reported by the participant.
Outcome measures
| Measure |
Group 1 Classic
n=147 Participants
Group 1 Using the classic inserting technique and completely deflated LMA recommended in the LMA manual.
Group 1 Classic: Active Comparator: Group 1 classic
Group 1 Using the classic inserting technique and completely deflated LMA recommended in the LMA manual.
|
Group 2 Pre Inflated
n=145 Participants
Group 2 (pre-inflated): Using the recommended inserting technique with the pre-inflated volume that exists in a LMA from the manufacturer
Group 2 pre-inflated: Group 2 (pre-inflated): Using the recommended inserting technique with the pre-inflated volume that exists in a LMA from the manufacturer.
|
Group 3 ELL-PIC Technique
n=149 Participants
Group 3 (ELL-PIC): Using the ELL-PIC technique.
Group 3 ELL-PIC: Group 3 (ELL-PIC): Using the ELL-PIC technique
|
|---|---|---|---|
|
Number of Subjects Who Present With Postoperative Sore Throat
|
71 Participants
|
71 Participants
|
67 Participants
|
PRIMARY outcome
Timeframe: 24 hoursThe primary outcomes for this study will be postoperative pharyngolaryngeal complications including dysphonia. Difficulty in speaking as assessed by the study team and reported by the participant 24 hours after LMA airway placement.
Outcome measures
| Measure |
Group 1 Classic
n=147 Participants
Group 1 Using the classic inserting technique and completely deflated LMA recommended in the LMA manual.
Group 1 Classic: Active Comparator: Group 1 classic
Group 1 Using the classic inserting technique and completely deflated LMA recommended in the LMA manual.
|
Group 2 Pre Inflated
n=145 Participants
Group 2 (pre-inflated): Using the recommended inserting technique with the pre-inflated volume that exists in a LMA from the manufacturer
Group 2 pre-inflated: Group 2 (pre-inflated): Using the recommended inserting technique with the pre-inflated volume that exists in a LMA from the manufacturer.
|
Group 3 ELL-PIC Technique
n=149 Participants
Group 3 (ELL-PIC): Using the ELL-PIC technique.
Group 3 ELL-PIC: Group 3 (ELL-PIC): Using the ELL-PIC technique
|
|---|---|---|---|
|
The Primary Outcomes for This Study Will be Postoperative Pharyngolaryngeal Complications Including Dysphonia
|
39 Participants
|
31 Participants
|
25 Participants
|
PRIMARY outcome
Timeframe: 24 hoursThe primary outcomes for this study will be postoperative pharyngolaryngeal complication of dysphagia 24 hours after airway placement. This is assessed by a study team member during the 24 hour follow up or reported by the participant.
Outcome measures
| Measure |
Group 1 Classic
n=147 Participants
Group 1 Using the classic inserting technique and completely deflated LMA recommended in the LMA manual.
Group 1 Classic: Active Comparator: Group 1 classic
Group 1 Using the classic inserting technique and completely deflated LMA recommended in the LMA manual.
|
Group 2 Pre Inflated
n=145 Participants
Group 2 (pre-inflated): Using the recommended inserting technique with the pre-inflated volume that exists in a LMA from the manufacturer
Group 2 pre-inflated: Group 2 (pre-inflated): Using the recommended inserting technique with the pre-inflated volume that exists in a LMA from the manufacturer.
|
Group 3 ELL-PIC Technique
n=149 Participants
Group 3 (ELL-PIC): Using the ELL-PIC technique.
Group 3 ELL-PIC: Group 3 (ELL-PIC): Using the ELL-PIC technique
|
|---|---|---|---|
|
The Primary Outcomes for This Study Will be Postoperative Dysphagia.
|
45 Participants
|
38 Participants
|
34 Participants
|
PRIMARY outcome
Timeframe: 24 hoursThe primary outcomes for this study will be postoperative pharyngolaryngeal complications including dysphagia, sore throat and dysphonia 24 hours after airway placement.
Outcome measures
| Measure |
Group 1 Classic
n=147 Participants
Group 1 Using the classic inserting technique and completely deflated LMA recommended in the LMA manual.
Group 1 Classic: Active Comparator: Group 1 classic
Group 1 Using the classic inserting technique and completely deflated LMA recommended in the LMA manual.
|
Group 2 Pre Inflated
n=145 Participants
Group 2 (pre-inflated): Using the recommended inserting technique with the pre-inflated volume that exists in a LMA from the manufacturer
Group 2 pre-inflated: Group 2 (pre-inflated): Using the recommended inserting technique with the pre-inflated volume that exists in a LMA from the manufacturer.
|
Group 3 ELL-PIC Technique
n=149 Participants
Group 3 (ELL-PIC): Using the ELL-PIC technique.
Group 3 ELL-PIC: Group 3 (ELL-PIC): Using the ELL-PIC technique
|
|---|---|---|---|
|
The Primary Outcomes for This Study Will be Postoperative Pharyngolaryngeal Complications Including Dysphagia, Sore Throat and Dysphonia.
|
83 Participants
|
80 Participants
|
78 Participants
|
SECONDARY outcome
Timeframe: 24 hoursSeverity of sore throat 24 hours after airway placement on a 11 point scale of 0-10 ( 0 equals no pain and 10 equals worst pain ever) per recovery hour. Low pain = 0 high pain= 500 composite score (0 to 11 points per hour x 24 hours)
Outcome measures
| Measure |
Group 1 Classic
n=147 Participants
Group 1 Using the classic inserting technique and completely deflated LMA recommended in the LMA manual.
Group 1 Classic: Active Comparator: Group 1 classic
Group 1 Using the classic inserting technique and completely deflated LMA recommended in the LMA manual.
|
Group 2 Pre Inflated
n=145 Participants
Group 2 (pre-inflated): Using the recommended inserting technique with the pre-inflated volume that exists in a LMA from the manufacturer
Group 2 pre-inflated: Group 2 (pre-inflated): Using the recommended inserting technique with the pre-inflated volume that exists in a LMA from the manufacturer.
|
Group 3 ELL-PIC Technique
n=149 Participants
Group 3 (ELL-PIC): Using the ELL-PIC technique.
Group 3 ELL-PIC: Group 3 (ELL-PIC): Using the ELL-PIC technique
|
|---|---|---|---|
|
Severity of Sore Throat
|
143 units on a scale
Interval 30.0 to 440.0
|
143 units on a scale
Interval 24.0 to 440.0
|
102 units on a scale
Interval 34.0 to 275.0
|
SECONDARY outcome
Timeframe: Immediately after LMA removalPresence of blood immediately after the removal of the LMA after surgery.
Outcome measures
| Measure |
Group 1 Classic
n=147 Participants
Group 1 Using the classic inserting technique and completely deflated LMA recommended in the LMA manual.
Group 1 Classic: Active Comparator: Group 1 classic
Group 1 Using the classic inserting technique and completely deflated LMA recommended in the LMA manual.
|
Group 2 Pre Inflated
n=145 Participants
Group 2 (pre-inflated): Using the recommended inserting technique with the pre-inflated volume that exists in a LMA from the manufacturer
Group 2 pre-inflated: Group 2 (pre-inflated): Using the recommended inserting technique with the pre-inflated volume that exists in a LMA from the manufacturer.
|
Group 3 ELL-PIC Technique
n=149 Participants
Group 3 (ELL-PIC): Using the ELL-PIC technique.
Group 3 ELL-PIC: Group 3 (ELL-PIC): Using the ELL-PIC technique
|
|---|---|---|---|
|
Blood on LMA After Removal
|
26 Participants
|
24 Participants
|
13 Participants
|
Adverse Events
Group 1 Classic
Serious events: 0 serious events
Other events: 83 other events
Deaths: 0 deaths
Group 2 Pre Inflated
Serious events: 0 serious events
Other events: 80 other events
Deaths: 0 deaths
Group 3 ELLIA Technique
Serious events: 0 serious events
Other events: 78 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1 Classic
n=147 participants at risk
Group 1 Using the classic inserting technique and completely deflated LMA recommended in the LMA manual.
Group 1 Classic: Active Comparator: Group 1 classic
Group 1 Using the classic inserting technique and completely deflated LMA recommended in the LMA manual.
|
Group 2 Pre Inflated
n=145 participants at risk
Group 2 (pre-inflated): Using the recommended inserting technique with the pre-inflated volume that exists in a LMA from the manufacturer
Group 2 pre-inflated: Group 2 (pre-inflated): Using the recommended inserting technique with the pre-inflated volume that exists in a LMA from the manufacturer.
|
Group 3 ELLIA Technique
n=149 participants at risk
Group 3 (ELLIA): Using the ELLIA technique.
Group 3 ELLIA: Group 3 (ELLIA): Using the ELLIA technique
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Postoperative Pharyngolaryngeal Complications Including Dysphagia, Sore Throat and Dysphonia.
|
56.5%
83/147 • Number of events 83 • 24 hours after the airway device removal
|
55.2%
80/145 • Number of events 80 • 24 hours after the airway device removal
|
52.3%
78/149 • Number of events 78 • 24 hours after the airway device removal
|
|
Respiratory, thoracic and mediastinal disorders
Blood on OMA after removal of the OMA
|
17.7%
26/147 • Number of events 26 • 24 hours after the airway device removal
|
16.6%
24/145 • Number of events 24 • 24 hours after the airway device removal
|
8.7%
13/149 • Number of events 13 • 24 hours after the airway device removal
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place