Trial Outcomes & Findings for Second Generation LMA Versus Endotracheal Tube in Obese Patients (NCT NCT03748342)
NCT ID: NCT03748342
Last Updated: 2025-04-17
Results Overview
Patients in the 2 groups will be assessed for postoperative hypoxia (1 or more episodes) in the PACU using a visual analog scale.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
97 participants
Primary outcome timeframe
Up to 80 minutes post-operatively
Results posted on
2025-04-17
Participant Flow
Participant milestones
| Measure |
Standard Endotracheal Tube
Normal endotracheal tube
|
Second-Generation LMA
Second-Generation Laryngeal Mask Airway: A second-generation LMA will be used for airway management (instead of ETT).
|
|---|---|---|
|
Overall Study
STARTED
|
48
|
49
|
|
Overall Study
COMPLETED
|
48
|
49
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Second Generation LMA Versus Endotracheal Tube in Obese Patients
Baseline characteristics by cohort
| Measure |
Standard Endotracheal Tube
n=48 Participants
7.0/8.0 ETT
|
Second-Generation LMA
n=49 Participants
Second-Generation Laryngeal Mask Airway: A second-generation LMA will be used for airway management (instead of ETT).
|
Total
n=97 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.38 years
STANDARD_DEVIATION 13.63 • n=5 Participants
|
47.06 years
STANDARD_DEVIATION 14.32 • n=7 Participants
|
46.23 years
STANDARD_DEVIATION 13.93 • n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
36 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
5 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
BMI
|
34.53 kg/m2
STANDARD_DEVIATION 4.91 • n=5 Participants
|
35.8 kg/m2
STANDARD_DEVIATION 5.11 • n=7 Participants
|
35.17 kg/m2
STANDARD_DEVIATION 5.03 • n=5 Participants
|
|
Smoking Status
Never
|
34 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Smoking Status
Used to but quit
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Smoking Status
Current Smoker
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 80 minutes post-operativelyPatients in the 2 groups will be assessed for postoperative hypoxia (1 or more episodes) in the PACU using a visual analog scale.
Outcome measures
| Measure |
Standard Endotracheal Tube
n=48 Participants
Normal endotracheal tube
|
Second-Generation LMA
n=49 Participants
Second-Generation Laryngeal Mask Airway: A second-generation LMA will be used for airway management (instead of ETT).
|
|---|---|---|
|
Proportion of Participants With Postoperative Hypoxia
|
54.2 percentage of participants
|
34.7 percentage of participants
|
SECONDARY outcome
Timeframe: Intra-operativelyBlood pressure monitor readings (events) will be recorded throughout the surgery and compared to baseline pre-operative values.
Outcome measures
| Measure |
Standard Endotracheal Tube
n=48 Participants
Normal endotracheal tube
|
Second-Generation LMA
n=49 Participants
Second-Generation Laryngeal Mask Airway: A second-generation LMA will be used for airway management (instead of ETT).
|
|---|---|---|
|
Alterations in Blood Pressure
|
0 events
|
0 events
|
SECONDARY outcome
Timeframe: Intra-operativelyHeart rate monitor readings (events) will be recorded throughout the surgery and compared to baseline pre-operative values.
Outcome measures
| Measure |
Standard Endotracheal Tube
n=48 Participants
Normal endotracheal tube
|
Second-Generation LMA
n=49 Participants
Second-Generation Laryngeal Mask Airway: A second-generation LMA will be used for airway management (instead of ETT).
|
|---|---|---|
|
Alterations in Heart Rate
|
0 events
|
0 events
|
SECONDARY outcome
Timeframe: BaselineOxygen saturation readings (events) will be recorded throughout the surgery and compared to baseline pre-operative values. Number of participants that did not require O2 is reported in the data table below.
Outcome measures
| Measure |
Standard Endotracheal Tube
n=48 Participants
Normal endotracheal tube
|
Second-Generation LMA
n=49 Participants
Second-Generation Laryngeal Mask Airway: A second-generation LMA will be used for airway management (instead of ETT).
|
|---|---|---|
|
Alterations in Oxygen Saturation (at Baseline)
|
0 events
|
0 events
|
SECONDARY outcome
Timeframe: at 15 mins postoperativelyOxygen saturation readings (at T15- after 15 mins in PACU) will be recorded throughout the surgery and compared to baseline pre-operative values.
Outcome measures
| Measure |
Standard Endotracheal Tube
n=48 Participants
Normal endotracheal tube
|
Second-Generation LMA
n=49 Participants
Second-Generation Laryngeal Mask Airway: A second-generation LMA will be used for airway management (instead of ETT).
|
|---|---|---|
|
Alterations in Oxygen Saturation (at T15)
O2 required (SpO2<95%)
|
10 Participants
|
10 Participants
|
|
Alterations in Oxygen Saturation (at T15)
O2 not required
|
38 Participants
|
39 Participants
|
SECONDARY outcome
Timeframe: at 45 mins postoperativelyOxygen saturation readings (at T45- after 45 mins in PACU) will be recorded throughout the surgery and compared to baseline pre-operative values.
Outcome measures
| Measure |
Standard Endotracheal Tube
n=48 Participants
Normal endotracheal tube
|
Second-Generation LMA
n=49 Participants
Second-Generation Laryngeal Mask Airway: A second-generation LMA will be used for airway management (instead of ETT).
|
|---|---|---|
|
Alterations in Oxygen Saturation (at T45)
O2 required (SpO2<90%)
|
3 Participants
|
0 Participants
|
|
Alterations in Oxygen Saturation (at T45)
O2 required (SpO2<95%)
|
3 Participants
|
3 Participants
|
|
Alterations in Oxygen Saturation (at T45)
O2 not required
|
42 Participants
|
46 Participants
|
SECONDARY outcome
Timeframe: at 80 mins postoperativelyOxygen saturation readings (at T80- after 80 mins in PACU) will be recorded throughout the surgery and compared to baseline pre-operative values.
Outcome measures
| Measure |
Standard Endotracheal Tube
n=47 Participants
Normal endotracheal tube
|
Second-Generation LMA
n=49 Participants
Second-Generation Laryngeal Mask Airway: A second-generation LMA will be used for airway management (instead of ETT).
|
|---|---|---|
|
Alterations in Oxygen Saturation (at T80)
O2 required (SpO2<90%)
|
3 Participants
|
0 Participants
|
|
Alterations in Oxygen Saturation (at T80)
O2 required (SpO2<95%)
|
2 Participants
|
1 Participants
|
|
Alterations in Oxygen Saturation (at T80)
O2 not required
|
42 Participants
|
48 Participants
|
SECONDARY outcome
Timeframe: BaselineRespiratory rate readings (events) will be recorded at baseline.
Outcome measures
| Measure |
Standard Endotracheal Tube
n=48 Participants
Normal endotracheal tube
|
Second-Generation LMA
n=49 Participants
Second-Generation Laryngeal Mask Airway: A second-generation LMA will be used for airway management (instead of ETT).
|
|---|---|---|
|
Alterations in Respiratory Rate
|
16.33 events
Standard Deviation 2.04
|
16.2 events
Standard Deviation 2.16
|
Adverse Events
Standard Endotracheal Tube
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Second-Generation LMA
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