Trial Outcomes & Findings for A Dual Channel Supraglottic Airway Device (LMA Gastro) for Oxygenation in Patients Undergoing ERCP (NCT NCT04740164)
NCT ID: NCT04740164
Last Updated: 2024-11-06
Results Overview
The desaturation (SpO2 \< 90%) between patients undergoing ERCP with LMA® Gastro™ vs standard nasal cannula
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
66 participants
Primary outcome timeframe
The time between Anesthesia Start time and Anesthesia End time, 1.5 hrs in average
Results posted on
2024-11-06
Participant Flow
This study enrolled 66 patients from 02/24/2021 to 06/24/2022. Patients ≥18 years old undergoing elective ERCP with TIVA were eligible for enrollment.
Participant milestones
| Measure |
LMA Gastro
This group of patients received GA during their procedure, using LMA Gastro for intubation.
|
Standard of Care
This group received TIVA during their procedure.
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
33
|
|
Overall Study
COMPLETED
|
26
|
30
|
|
Overall Study
NOT COMPLETED
|
7
|
3
|
Reasons for withdrawal
| Measure |
LMA Gastro
This group of patients received GA during their procedure, using LMA Gastro for intubation.
|
Standard of Care
This group received TIVA during their procedure.
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
4
|
0
|
|
Overall Study
Physician Decision
|
3
|
3
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
LMA Gastro
n=26 Participants
This group of patients received GA during their procedure, using LMA Gastro for intubation.
|
Standard of Care
n=30 Participants
This group received TIVA during their procedure.
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.6154 years
n=26 Participants
|
62.8667 years
n=30 Participants
|
59.96 years
n=56 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=26 Participants
|
8 Participants
n=30 Participants
|
23 Participants
n=56 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=26 Participants
|
22 Participants
n=30 Participants
|
33 Participants
n=56 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
26 participants
n=26 Participants
|
30 participants
n=30 Participants
|
56 participants
n=56 Participants
|
|
ASA Status (grade)
II (better)
|
0 Participants
n=26 Participants
|
1 Participants
n=30 Participants
|
1 Participants
n=56 Participants
|
|
ASA Status (grade)
III (worse)
|
26 Participants
n=26 Participants
|
29 Participants
n=30 Participants
|
55 Participants
n=56 Participants
|
PRIMARY outcome
Timeframe: The time between Anesthesia Start time and Anesthesia End time, 1.5 hrs in averageThe desaturation (SpO2 \< 90%) between patients undergoing ERCP with LMA® Gastro™ vs standard nasal cannula
Outcome measures
| Measure |
LMA Gastro
n=26 Participants
This group of patients received GA during their procedure, using LMA Gastro for intubation.
|
Standard of Care
n=30 Participants
This group received TIVA during their procedure.
|
|---|---|---|
|
Number of Participants That Had Desaturation Episodes of SpO2 <90%
Desaturation <90% - Yes
|
0 Participants
|
3 Participants
|
|
Number of Participants That Had Desaturation Episodes of SpO2 <90%
Desaturation <90% - No
|
26 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: The time between Anesthesia Start time and Anesthesia End time, 1.5 hrs in averageNumber of Participants that required additional manuevers to secure airway during their surgery
Outcome measures
| Measure |
LMA Gastro
n=26 Participants
This group of patients received GA during their procedure, using LMA Gastro for intubation.
|
Standard of Care
n=30 Participants
This group received TIVA during their procedure.
|
|---|---|---|
|
Incidence of Additional Airway Maneuvers
Yes
|
5 Participants
|
19 Participants
|
|
Incidence of Additional Airway Maneuvers
No
|
21 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: The time between Anesthesia Start time and Anesthesia End timePatients in which Duodenoscope was withdrawn to facilitate airway support
Outcome measures
| Measure |
LMA Gastro
n=26 Participants
This group of patients received GA during their procedure, using LMA Gastro for intubation.
|
Standard of Care
n=30 Participants
This group received TIVA during their procedure.
|
|---|---|---|
|
Incidence of Withdrawal of Duodenoscope From Airway to Facilitate Airway Support
Yes
|
9 Participants
|
10 Participants
|
|
Incidence of Withdrawal of Duodenoscope From Airway to Facilitate Airway Support
No
|
17 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: From PACU arrival to PACU discharge, 3 hours in averageNumber of adverse events reported by the participants and/or reported by care providers during Surgery and in PACU, 3 hrs in average
Outcome measures
| Measure |
LMA Gastro
n=26 Participants
This group of patients received GA during their procedure, using LMA Gastro for intubation.
|
Standard of Care
n=30 Participants
This group received TIVA during their procedure.
|
|---|---|---|
|
Incidence of Adverse Events
|
24 events
|
3 events
|
SECONDARY outcome
Timeframe: From anesthesia start to anesthesia end" and "procedure start to procedure end, up to 165 minutesDefined as "anesthesia start to anesthesia end" and "procedure start to procedure end" respectively
Outcome measures
| Measure |
LMA Gastro
n=26 Participants
This group of patients received GA during their procedure, using LMA Gastro for intubation.
|
Standard of Care
n=30 Participants
This group received TIVA during their procedure.
|
|---|---|---|
|
To Evaluate Times Related to Anesthesia and Procedure
Total Anesthesia Time
|
75.0769 minutes
Interval 46.0 to 152.0
|
62.8667 minutes
Interval 35.0 to 165.0
|
|
To Evaluate Times Related to Anesthesia and Procedure
Total Procedure Time
|
32.6154 minutes
Interval 3.0 to 113.0
|
45.5333 minutes
Interval 13.0 to 143.0
|
SECONDARY outcome
Timeframe: From procedure end and anesthesia end, up to 60 minutesThe time elapsed between procedure end and anesthesia end
Outcome measures
| Measure |
LMA Gastro
n=26 Participants
This group of patients received GA during their procedure, using LMA Gastro for intubation.
|
Standard of Care
n=30 Participants
This group received TIVA during their procedure.
|
|---|---|---|
|
To Evaluate Time From Procedure End to Anesthesia End
|
18.5769 minutes
Interval 10.0 to 49.0
|
11.2 minutes
Interval 2.0 to 22.0
|
SECONDARY outcome
Timeframe: From "anesthesia start" to "anesthesia end", on average 5 hoursHeart rates were measured prior treatment administration and at the end of the procedure.
Outcome measures
| Measure |
LMA Gastro
n=26 Participants
This group of patients received GA during their procedure, using LMA Gastro for intubation.
|
Standard of Care
n=30 Participants
This group received TIVA during their procedure.
|
|---|---|---|
|
To Describe Heart Rates Within the Two Groups
Heart rate post intervention
|
77.1154 bpm
Standard Deviation 15.8501
|
66.9667 bpm
Standard Deviation 10.3607
|
|
To Describe Heart Rates Within the Two Groups
Heart rate prior to intervention
|
79.8846 bpm
Standard Deviation 16.7412
|
77.3667 bpm
Standard Deviation 13.7853
|
SECONDARY outcome
Timeframe: From "anesthesia start" to "anesthesia end", on average 5 hoursBlood pressure and end tidal carbon dioxide \[CO2\] were measured prior treatment administration and at the end of the procedure.
Outcome measures
| Measure |
LMA Gastro
n=26 Participants
This group of patients received GA during their procedure, using LMA Gastro for intubation.
|
Standard of Care
n=30 Participants
This group received TIVA during their procedure.
|
|---|---|---|
|
To Describe Blood Pressure and End Tidal Carbon Dioxide [CO2] Within the Two Groups
Systolic Blood pressure prior to intervention
|
127.2308 mmhg
Standard Deviation 19.4757
|
137.5714 mmhg
Standard Deviation 28.3097
|
|
To Describe Blood Pressure and End Tidal Carbon Dioxide [CO2] Within the Two Groups
Systolic Blood pressure post intervention
|
122.0769 mmhg
Standard Deviation 15.0676
|
128.2 mmhg
Standard Deviation 23.5231
|
|
To Describe Blood Pressure and End Tidal Carbon Dioxide [CO2] Within the Two Groups
Diastolic Blood pressure prior to intervention
|
78.3462 mmhg
Standard Deviation 10.7664
|
80.8571 mmhg
Standard Deviation 15.1846
|
|
To Describe Blood Pressure and End Tidal Carbon Dioxide [CO2] Within the Two Groups
Diastolic Blood pressure post intervention
|
76.9231 mmhg
Standard Deviation 10.0833
|
77.7 mmhg
Standard Deviation 15.0611
|
|
To Describe Blood Pressure and End Tidal Carbon Dioxide [CO2] Within the Two Groups
End tidal carbon dioxide [CO2] prior to intervention
|
18.6364 mmhg
Standard Deviation 11.4129
|
25.2 mmhg
Standard Deviation 11.7858
|
|
To Describe Blood Pressure and End Tidal Carbon Dioxide [CO2] Within the Two Groups
End tidal carbon dioxide [CO2] post intervention
|
22.0769 mmhg
Standard Deviation 9.1693
|
28.75 mmhg
Standard Deviation 10.707
|
SECONDARY outcome
Timeframe: From "anesthesia start" to "anesthesia end", on average 5 hoursOxygen saturations were measured prior treatment administration and at the end of the procedure.
Outcome measures
| Measure |
LMA Gastro
n=26 Participants
This group of patients received GA during their procedure, using LMA Gastro for intubation.
|
Standard of Care
n=30 Participants
This group received TIVA during their procedure.
|
|---|---|---|
|
To Describe Oxygen Saturations Within the Two Groups
Oxygen saturation prior to intervention
|
98.5769 percentage of saturation
Standard Deviation 1.9426
|
99.033 percentage of saturation
Standard Deviation 1.1885
|
|
To Describe Oxygen Saturations Within the Two Groups
Oxygen saturation post intervention
|
93.7692 percentage of saturation
Standard Deviation 1.6796
|
98.5 percentage of saturation
Standard Deviation 1.9783
|
SECONDARY outcome
Timeframe: At the end of procedure, between 5 - 10 minutesPopulation: This outcome is evaluating the providers not participants. This outcome is only applicable to the LMA Gastro arm since it is in this arm we are using the study device.
Number of attempts means how many times the anesthesiologist tried to secure airway.
Outcome measures
| Measure |
LMA Gastro
n=5 Participants
This group of patients received GA during their procedure, using LMA Gastro for intubation.
|
Standard of Care
This group received TIVA during their procedure.
|
|---|---|---|
|
To Evaluate Anesthesiologist Placing the Device
Successful on Attempt 1
|
77 percentage of successful attempts
|
—
|
|
To Evaluate Anesthesiologist Placing the Device
Successful on Attempt 2
|
19 percentage of successful attempts
|
—
|
|
To Evaluate Anesthesiologist Placing the Device
Successful on Attempt 3
|
4 percentage of successful attempts
|
—
|
Adverse Events
LMA Gastro
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Standard of Care
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
LMA Gastro
n=26 participants at risk
This group of patients received GA during their procedure, using LMA Gastro for intubation.
|
Standard of Care
n=30 participants at risk
This group received TIVA during their procedure.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Horseness
|
15.4%
4/26 • Number of events 4 • Since anesthesia start to discharge ready in PACU, up to 5 hours
|
3.3%
1/30 • Number of events 1 • Since anesthesia start to discharge ready in PACU, up to 5 hours
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
50.0%
13/26 • Number of events 13 • Since anesthesia start to discharge ready in PACU, up to 5 hours
|
6.7%
2/30 • Number of events 2 • Since anesthesia start to discharge ready in PACU, up to 5 hours
|
|
General disorders
Sore mouth
|
7.7%
2/26 • Number of events 2 • Since anesthesia start to discharge ready in PACU, up to 5 hours
|
0.00%
0/30 • Since anesthesia start to discharge ready in PACU, up to 5 hours
|
|
Musculoskeletal and connective tissue disorders
Sore Jaw
|
7.7%
2/26 • Number of events 2 • Since anesthesia start to discharge ready in PACU, up to 5 hours
|
0.00%
0/30 • Since anesthesia start to discharge ready in PACU, up to 5 hours
|
|
General disorders
Dysphagia
|
15.4%
4/26 • Number of events 4 • Since anesthesia start to discharge ready in PACU, up to 5 hours
|
0.00%
0/30 • Since anesthesia start to discharge ready in PACU, up to 5 hours
|
Additional Information
Dr. Katherine Hagan
The University of Texas MD Anderson Cancer Center
Phone: (713) 794-5945
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place