Trial Outcomes & Findings for Geriatric Patients and Laryngeal Mask Unique (NCT NCT02219282)
NCT ID: NCT02219282
Last Updated: 2017-06-29
Results Overview
The aim of this study is primarily to measure the success of placement on first try in dentulous and edentulous elderly patients for success of placement on first try.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
66 participants
Primary outcome timeframe
Baseline
Results posted on
2017-06-29
Participant Flow
Participant milestones
| Measure |
Group Dentulous
Laryngeal Mask Unique insertion
Laryngeal Mask Unique insertion: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience.
|
Group Edentulous
Laryngeal Mask Unique insertion
Laryngeal Mask Unique insertion: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience.
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
33
|
|
Overall Study
COMPLETED
|
32
|
32
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Geriatric Patients and Laryngeal Mask Unique
Baseline characteristics by cohort
| Measure |
Group Dentulous
n=33 Participants
Laryngeal Mask Unique insertion
Laryngeal Mask Unique insertion: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience.
|
Group Edentulous
n=33 Participants
Laryngeal Mask Unique insertion
Laryngeal Mask Unique insertion: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience.
|
Total
n=66 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
|
33 Participants
n=93 Participants
|
33 Participants
n=4 Participants
|
66 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
46 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
|
Region of Enrollment
Turkey
|
33 participants
n=93 Participants
|
33 participants
n=4 Participants
|
66 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: For one patient in each group, dentulous and edentulous, insertion of the LMU was unsuccessful on the third attempt, and these patients were intubated; therefore, these two patients were excluded from the study and were not included in the statistical analysis
The aim of this study is primarily to measure the success of placement on first try in dentulous and edentulous elderly patients for success of placement on first try.
Outcome measures
| Measure |
Group Dentulous
n=32 Participants
Laryngeal Mask Unique insertion
Laryngeal Mask Unique insertion: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience.
|
Group Edentulous
n=32 Participants
Laryngeal Mask Unique insertion
Laryngeal Mask Unique insertion: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience.
|
|---|---|---|
|
Number of Participants With Successful Laryngeal Mask Placement
First Attempt
|
26 Participants
|
20 Participants
|
|
Number of Participants With Successful Laryngeal Mask Placement
Second Attempt
|
6 Participants
|
11 Participants
|
|
Number of Participants With Successful Laryngeal Mask Placement
Third attempt
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: BaselineOropharyngeal leak pressure (cm H20) in dentulous and edentulous elderly patients.
Outcome measures
| Measure |
Group Dentulous
n=32 Participants
Laryngeal Mask Unique insertion
Laryngeal Mask Unique insertion: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience.
|
Group Edentulous
n=32 Participants
Laryngeal Mask Unique insertion
Laryngeal Mask Unique insertion: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience.
|
|---|---|---|
|
Oropharyngeal Leak Pressure
|
21.75 cm H20
Standard Deviation 4.62
|
20.75 cm H20
Standard Deviation 5.04
|
SECONDARY outcome
Timeframe: Before anesthesia induction, before laryngeal mask insertion and in the 1st, 2nd, 3rd and 5th minutes after laryngeal mask insertionMean blood pressure (MBP) (mmHg) were recorded in both groups.
Outcome measures
| Measure |
Group Dentulous
n=32 Participants
Laryngeal Mask Unique insertion
Laryngeal Mask Unique insertion: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience.
|
Group Edentulous
n=32 Participants
Laryngeal Mask Unique insertion
Laryngeal Mask Unique insertion: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience.
|
|---|---|---|
|
Haemodynamic Response to Insertion of Airway Device.
Before anesthesia induction
|
94.3 mmHg
Standard Deviation 10
|
95.1 mmHg
Standard Deviation 12
|
|
Haemodynamic Response to Insertion of Airway Device.
before laryngeal mask insertion
|
80.1 mmHg
Standard Deviation 8
|
80.2 mmHg
Standard Deviation 9
|
|
Haemodynamic Response to Insertion of Airway Device.
1 minutes after laryngeal mask insertion
|
80.1 mmHg
Standard Deviation 5
|
79.2 mmHg
Standard Deviation 6
|
|
Haemodynamic Response to Insertion of Airway Device.
2 minutes after laryngeal mask insertion
|
70.2 mmHg
Standard Deviation 8
|
73.1 mmHg
Standard Deviation 6
|
|
Haemodynamic Response to Insertion of Airway Device.
3 minutes after laryngeal mask insertion
|
71.2 mmHg
Standard Deviation 7
|
70.3 mmHg
Standard Deviation 8
|
|
Haemodynamic Response to Insertion of Airway Device.
5 minutes after laryngeal mask insertion
|
70.4 mmHg
Standard Deviation 7
|
72.6 mmHg
Standard Deviation 8
|
SECONDARY outcome
Timeframe: During Laryngeal mask placementEase (according to Likert scale 1-4 point from easy to diffucult).
Outcome measures
| Measure |
Group Dentulous
n=32 Participants
Laryngeal Mask Unique insertion
Laryngeal Mask Unique insertion: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience.
|
Group Edentulous
n=32 Participants
Laryngeal Mask Unique insertion
Laryngeal Mask Unique insertion: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience.
|
|---|---|---|
|
Ease of Placement Laryngeal Mask
1
|
30 Participants
|
25 Participants
|
|
Ease of Placement Laryngeal Mask
2
|
2 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: During placement of Laryngeal MaskDuration of insertion (second) Laryngeal Mask;second
Outcome measures
| Measure |
Group Dentulous
n=32 Participants
Laryngeal Mask Unique insertion
Laryngeal Mask Unique insertion: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience.
|
Group Edentulous
n=32 Participants
Laryngeal Mask Unique insertion
Laryngeal Mask Unique insertion: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience.
|
|---|---|---|
|
Insertion Time of Laryngeal Mask
|
14.40 seconds
Standard Deviation 4.80
|
13.43 seconds
Standard Deviation 4.11
|
Adverse Events
Group Dentulous
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group Edentulous
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