Trial Outcomes & Findings for The Laryngeal Mask Airway in Edentulous Geriatric Patients (NCT NCT02197377)
NCT ID: NCT02197377
Last Updated: 2018-10-19
Results Overview
Edentulous elderly patients for the success in first attempt insertion, ease and time of insertion (second).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
after anaesthesia induction
Results posted on
2018-10-19
Participant Flow
Participant milestones
| Measure |
Group LMA Unique
The supraglottic airway devices were deflated fully before insertion. Size 4 LMA was used for those with a weight of 50-70 kg and size 5 LMA for those between 70-100 kg. After insertion, each device was inflated with a hand-held airway manometer (Rusch, Germany) to an intracuff pressure of 60 cm H2O.
Group LMA Supreme™: The supraglottic airway devices were deflated fully before insertion.
|
Group LMA Supreme
The supraglottic airway devices were deflated fully before insertion. Size 4 LMA was used for those with a weight of 50-70 kg and size 5 LMA for those between 70-100 kg. After insertion, each device was inflated with a hand-held airway manometer (Rusch, Germany) to an intracuff pressure of 60 cm H2O.
Group LMA Unique™: The supraglottic airway devices were deflated fully before insertion.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
30
|
27
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
| Measure |
Group LMA Unique
The supraglottic airway devices were deflated fully before insertion. Size 4 LMA was used for those with a weight of 50-70 kg and size 5 LMA for those between 70-100 kg. After insertion, each device was inflated with a hand-held airway manometer (Rusch, Germany) to an intracuff pressure of 60 cm H2O.
Group LMA Supreme™: The supraglottic airway devices were deflated fully before insertion.
|
Group LMA Supreme
The supraglottic airway devices were deflated fully before insertion. Size 4 LMA was used for those with a weight of 50-70 kg and size 5 LMA for those between 70-100 kg. After insertion, each device was inflated with a hand-held airway manometer (Rusch, Germany) to an intracuff pressure of 60 cm H2O.
Group LMA Unique™: The supraglottic airway devices were deflated fully before insertion.
|
|---|---|---|
|
Overall Study
Insertion Failure
|
0
|
3
|
Baseline Characteristics
The Laryngeal Mask Airway in Edentulous Geriatric Patients
Baseline characteristics by cohort
| Measure |
Group LMA Unique
n=30 Participants
The supraglottic airway devices were deflated fully before insertion. Size 4 LMA was used for those with a weight of 50-70 kg and size 5 LMA for those between 70-100 kg. After insertion, each device was inflated with a hand-held airway manometer (Rusch, Germany) to an intracuff pressure of 60 cm H2O.
Group LMA Supreme™: The supraglottic airway devices were deflated fully before insertion.
|
Group LMA Supreme
n=27 Participants
The supraglottic airway devices were deflated fully before insertion. Size 4 LMA was used for those with a weight of 50-70 kg and size 5 LMA for those between 70-100 kg. After insertion, each device was inflated with a hand-held airway manometer (Rusch, Germany) to an intracuff pressure of 60 cm H2O.
Group LMA Unique™: The supraglottic airway devices were deflated fully before insertion.
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
30 Participants
n=93 Participants
|
27 Participants
n=4 Participants
|
57 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
37 Participants
n=27 Participants
|
|
Region of Enrollment
Turkey
|
30 participants
n=93 Participants
|
27 participants
n=4 Participants
|
57 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: after anaesthesia inductionPopulation: Non parametric data between groups were analyzed with the X2-test, while parametric data were compared with unpaired t-test. P \< 0.05 was considered significant. 3 LMA insertion failed in Group LMA Supreme. Total 27 patients included analysis.
Edentulous elderly patients for the success in first attempt insertion, ease and time of insertion (second).
Outcome measures
| Measure |
Group LMA Unique
n=30 Participants
The supraglottic airway devices were deflated fully before insertion. Size 4 LMA was used for those with a weight of 50-70 kg and size 5 LMA for those between 70-100 kg. After insertion, each device was inflated with a hand-held airway manometer (Rusch, Germany) to an intracuff pressure of 60 cm H2O.
Group LMA Supreme™: The supraglottic airway devices were deflated fully before insertion.
|
Group LMA Supreme
n=27 Participants
The supraglottic airway devices were deflated fully before insertion. Size 4 LMA was used for those with a weight of 50-70 kg and size 5 LMA for those between 70-100 kg. After insertion, each device was inflated with a hand-held airway manometer (Rusch, Germany) to an intracuff pressure of 60 cm H2O.
Group LMA Unique™: The supraglottic airway devices were deflated fully before insertion.
|
|---|---|---|
|
First Attempt's Success Rate of Insertion
|
73.3 percentage of participants
|
86.6 percentage of participants
|
SECONDARY outcome
Timeframe: before surgeryPopulation: Non parametric data between groups were analyzed with the X2-test, while parametric data were compared with unpaired t-test. P \< 0.05 was considered significant.
The aim of this study is to compare on the oropharyngeal leak pressure in LMA Unique™ and LMA Supreme™ applications
Outcome measures
| Measure |
Group LMA Unique
n=30 Participants
The supraglottic airway devices were deflated fully before insertion. Size 4 LMA was used for those with a weight of 50-70 kg and size 5 LMA for those between 70-100 kg. After insertion, each device was inflated with a hand-held airway manometer (Rusch, Germany) to an intracuff pressure of 60 cm H2O.
Group LMA Supreme™: The supraglottic airway devices were deflated fully before insertion.
|
Group LMA Supreme
n=27 Participants
The supraglottic airway devices were deflated fully before insertion. Size 4 LMA was used for those with a weight of 50-70 kg and size 5 LMA for those between 70-100 kg. After insertion, each device was inflated with a hand-held airway manometer (Rusch, Germany) to an intracuff pressure of 60 cm H2O.
Group LMA Unique™: The supraglottic airway devices were deflated fully before insertion.
|
|---|---|---|
|
Oropharyngeal Leak Pressure
|
17.1 cm H20
Standard Deviation 6.33
|
20.56 cm H20
Standard Deviation 8.22
|
Adverse Events
Group LMA Unique
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group LMA Supreme
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place