Trial Outcomes & Findings for Comparison Between the I-gel and the LMA-Unique (NCT NCT02163486)
NCT ID: NCT02163486
Last Updated: 2018-10-19
Results Overview
The aim of this study is to compare the effect of different head and neck positions on the oropharyngeal leak pressure in LMA-Unique and I-Gel applications. Head and neck positions are limited to neutral, extension and right laterally deviated.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
103 participants
Primary outcome timeframe
Immediately after head and neck positioning is completed
Results posted on
2018-10-19
Participant Flow
Participant milestones
| Measure |
Group U (UNIQUE)
Group LMA- UNIQUE, inserted according to described standard method. Between 30-40 kg, no.3. Between 50-70 kg, no. 4 Between 70-100 kg, no. 5. LMA-Unique Before LMA-U is inserted, a water-based lubricant without local anesthetic, was spread on the surfaces that will touch the palate and LMA-Unique cuff was completely deflated. Group U (UNIQUE): Group Laryngeal Mask Airway-Unique.
Group U (UNIQUE): Before LMA-Unique was inserted, to lubricate the surface in contact with the palate a water-based gel without local anesthetic was applied to completely cover the LMA-Unique cuff.
|
Group I (I-GEL ): Group I-GEL
Group I (I-GEL): Between 30-60 kg, no. 3. Between 50-90 kg, no. 4. For \> 90 kg no.5. I-GEL
I-GEL: Before I-gel was inserted, to lubricate the surface in contact with the palate a water-based gel without local anesthetic was applied to completely cover the I-GEL cuff.
I-GEL: K-Y Jelly® is a registered trademark of Johnson and Johnson Inc
|
|---|---|---|
|
Overall Study
STARTED
|
51
|
52
|
|
Overall Study
COMPLETED
|
50
|
50
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison Between the I-gel and the LMA-Unique
Baseline characteristics by cohort
| Measure |
Group U (UNIQUE)
n=50 Participants
Group LMA- UNIQUE, inserted according to described standard method. Between 30-40 kg, no.3. Between 50-70 kg, no. 4 Between 70-100 kg, no. 5. LMA-Unique Before SGAD is inserted, a water-based lubricant without local anesthetic, was spread on the surfaces that will touch the palate and LMA-U cuff was completely deflated.oup U (UNIQUE): Group Laryngeal Mask Airway-Unique.
Group U (UNIQUE): Before LMA-Unique was inserted, to lubricate the surface in contact with the palate a water-based gel without local anesthetic was applied to completely cover the LMA-Unique cuff.
|
Group I (I-GEL ): Group I-GEL
n=50 Participants
Group I (I-GEL): Between 30-60 kg, no. 3. Between 50-90 kg, no. 4. For \> 90 kg no.5. I-GEL
I-GEL: Before I-gel was inserted, to lubricate the surface in contact with the palate a water-based gel without local anesthetic was applied to completely cover the I-GEL cuff.
I-GEL: K-Y Jelly® is a registered trademark of Johnson and Johnson Inc
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
50 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Region of Enrollment
Turkey
|
50 participants
n=5 Participants
|
50 participants
n=7 Participants
|
100 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Immediately after head and neck positioning is completedThe aim of this study is to compare the effect of different head and neck positions on the oropharyngeal leak pressure in LMA-Unique and I-Gel applications. Head and neck positions are limited to neutral, extension and right laterally deviated.
Outcome measures
| Measure |
Group U (UNIQUE)
n=50 Participants
Group LMA- UNIQUE, inserted according to described standard method. Between 30-40 kg, no.3. Between 50-70 kg, no. 4 Between 70-100 kg, no. 5. LMA-Unique Before SGAD is inserted, a water-based lubricant without local anesthetic, was spread on the surfaces that will touch the palate and LMA-U cuff was completely deflated.oup U (UNIQUE): Group Laryngeal Mask Airway-Unique.
Group U (UNIQUE): Before LMA-Unique was inserted, to lubricate the surface in contact with the palate a water-based gel without local anesthetic was applied to completely cover the LMA-Unique cuff.
|
Group I (I-GEL ): Group I-GEL
n=50 Participants
Group I (I-GEL): Between 30-60 kg, no. 3. Between 50-90 kg, no. 4. For \> 90 kg no.5. I-GEL
I-GEL: Before I-gel was inserted, to lubricate the surface in contact with the palate a water-based gel without local anesthetic was applied to completely cover the I-GEL cuff.
I-GEL: K-Y Jelly® is a registered trademark of Johnson and Johnson Inc
|
|---|---|---|
|
Oropharyngeal Leak Pressure
when neutral position
|
25.06 cm H20
Standard Deviation 7.53
|
28.24 cm H20
Standard Deviation 8.29
|
|
Oropharyngeal Leak Pressure
when extension position
|
22.88 cm H20
Standard Deviation 7.83
|
26.62 cm H20
Standard Deviation 8.77
|
|
Oropharyngeal Leak Pressure
when right position
|
27.30 cm H20
Standard Deviation 7.23
|
26.04 cm H20
Standard Deviation 8.61
|
SECONDARY outcome
Timeframe: Baseline to first successful ventilation, in secondsDuration from mouth opening to first successful ventilation, in seconds
Outcome measures
| Measure |
Group U (UNIQUE)
n=50 Participants
Group LMA- UNIQUE, inserted according to described standard method. Between 30-40 kg, no.3. Between 50-70 kg, no. 4 Between 70-100 kg, no. 5. LMA-Unique Before SGAD is inserted, a water-based lubricant without local anesthetic, was spread on the surfaces that will touch the palate and LMA-U cuff was completely deflated.oup U (UNIQUE): Group Laryngeal Mask Airway-Unique.
Group U (UNIQUE): Before LMA-Unique was inserted, to lubricate the surface in contact with the palate a water-based gel without local anesthetic was applied to completely cover the LMA-Unique cuff.
|
Group I (I-GEL ): Group I-GEL
n=50 Participants
Group I (I-GEL): Between 30-60 kg, no. 3. Between 50-90 kg, no. 4. For \> 90 kg no.5. I-GEL
I-GEL: Before I-gel was inserted, to lubricate the surface in contact with the palate a water-based gel without local anesthetic was applied to completely cover the I-GEL cuff.
I-GEL: K-Y Jelly® is a registered trademark of Johnson and Johnson Inc
|
|---|---|---|
|
The Time for Successful Placement (Second)
|
13.46 seconds
Standard Deviation 2.60
|
12.14 seconds
Standard Deviation 4.22
|
SECONDARY outcome
Timeframe: Baseline to first successful ventilation,Population: The number of patients with succesful placement of airway device at the first attempt
The number of attempts until succesful placement of airway device
Outcome measures
| Measure |
Group U (UNIQUE)
n=50 Participants
Group LMA- UNIQUE, inserted according to described standard method. Between 30-40 kg, no.3. Between 50-70 kg, no. 4 Between 70-100 kg, no. 5. LMA-Unique Before SGAD is inserted, a water-based lubricant without local anesthetic, was spread on the surfaces that will touch the palate and LMA-U cuff was completely deflated.oup U (UNIQUE): Group Laryngeal Mask Airway-Unique.
Group U (UNIQUE): Before LMA-Unique was inserted, to lubricate the surface in contact with the palate a water-based gel without local anesthetic was applied to completely cover the LMA-Unique cuff.
|
Group I (I-GEL ): Group I-GEL
n=50 Participants
Group I (I-GEL): Between 30-60 kg, no. 3. Between 50-90 kg, no. 4. For \> 90 kg no.5. I-GEL
I-GEL: Before I-gel was inserted, to lubricate the surface in contact with the palate a water-based gel without local anesthetic was applied to completely cover the I-GEL cuff.
I-GEL: K-Y Jelly® is a registered trademark of Johnson and Johnson Inc
|
|---|---|---|
|
Number of Attempts
Succesful second Attempt
|
2 Participants
|
1 Participants
|
|
Number of Attempts
Succesful third Attempt
|
0 Participants
|
1 Participants
|
|
Number of Attempts
Succesful First Attempt
|
48 Participants
|
48 Participants
|
SECONDARY outcome
Timeframe: BaselineEase of placement: 1. no reaction 2. straining, retching
Outcome measures
| Measure |
Group U (UNIQUE)
n=50 Participants
Group LMA- UNIQUE, inserted according to described standard method. Between 30-40 kg, no.3. Between 50-70 kg, no. 4 Between 70-100 kg, no. 5. LMA-Unique Before SGAD is inserted, a water-based lubricant without local anesthetic, was spread on the surfaces that will touch the palate and LMA-U cuff was completely deflated.oup U (UNIQUE): Group Laryngeal Mask Airway-Unique.
Group U (UNIQUE): Before LMA-Unique was inserted, to lubricate the surface in contact with the palate a water-based gel without local anesthetic was applied to completely cover the LMA-Unique cuff.
|
Group I (I-GEL ): Group I-GEL
n=50 Participants
Group I (I-GEL): Between 30-60 kg, no. 3. Between 50-90 kg, no. 4. For \> 90 kg no.5. I-GEL
I-GEL: Before I-gel was inserted, to lubricate the surface in contact with the palate a water-based gel without local anesthetic was applied to completely cover the I-GEL cuff.
I-GEL: K-Y Jelly® is a registered trademark of Johnson and Johnson Inc
|
|---|---|---|
|
Ease of Placement
no reaction
|
49 participants
|
49 participants
|
|
Ease of Placement
straining, retching
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: at postoperative 1st and 24th hoursPatients were asked about the presence of sore throat - defined as the presence of constant pain in the throat, voice loss and difficulty swallowing , at postoperative 1st and 24th hours.
Outcome measures
| Measure |
Group U (UNIQUE)
n=50 Participants
Group LMA- UNIQUE, inserted according to described standard method. Between 30-40 kg, no.3. Between 50-70 kg, no. 4 Between 70-100 kg, no. 5. LMA-Unique Before SGAD is inserted, a water-based lubricant without local anesthetic, was spread on the surfaces that will touch the palate and LMA-U cuff was completely deflated.oup U (UNIQUE): Group Laryngeal Mask Airway-Unique.
Group U (UNIQUE): Before LMA-Unique was inserted, to lubricate the surface in contact with the palate a water-based gel without local anesthetic was applied to completely cover the LMA-Unique cuff.
|
Group I (I-GEL ): Group I-GEL
n=50 Participants
Group I (I-GEL): Between 30-60 kg, no. 3. Between 50-90 kg, no. 4. For \> 90 kg no.5. I-GEL
I-GEL: Before I-gel was inserted, to lubricate the surface in contact with the palate a water-based gel without local anesthetic was applied to completely cover the I-GEL cuff.
I-GEL: K-Y Jelly® is a registered trademark of Johnson and Johnson Inc
|
|---|---|---|
|
Incidence of Post-operative Sore Throat
|
5 participants
|
0 participants
|
Adverse Events
Group U (UNIQUE)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group I (I-GEL ): Group I-GEL
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