Trial Outcomes & Findings for Laryngeal Mask Airway in Laparoscopic Hernia Repair (NCT NCT06023394)
NCT ID: NCT06023394
Last Updated: 2025-04-03
Results Overview
Oyxgen saturation will be measured by pulse oximetry in percent saturation at three time points during the anesthetic
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
62 participants
Primary outcome timeframe
Patients will have oxygen saturation measured directly after placement airway device, the first oxygen saturation recorded five minutes after the start of surgery, and immediately prior to removal airway device, assessed up to 2 hours.
Results posted on
2025-04-03
Participant Flow
Participant milestones
| Measure |
Cohort A: Receives Laryngeal Mask Airway Device
In this study arm, after induction of general anesthesia, the patients will receive a laryngeal mask airway device.
Laryngeal Mask Airway: Laryngeal mask airway will be used as an airway device for Cohort A in the standard fashion.
|
Cohort B: Receives Endotracheal Tube Device
In this arm, after induction of general anesthesia, the patients will receive an endotracheal tube airway device.
Endotracheal Tube Device: Endotracheal tube airway will be used as an airway device for Cohort B in the standard fashion.
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
31
|
|
Overall Study
COMPLETED
|
25
|
25
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
Reasons for withdrawal
| Measure |
Cohort A: Receives Laryngeal Mask Airway Device
In this study arm, after induction of general anesthesia, the patients will receive a laryngeal mask airway device.
Laryngeal Mask Airway: Laryngeal mask airway will be used as an airway device for Cohort A in the standard fashion.
|
Cohort B: Receives Endotracheal Tube Device
In this arm, after induction of general anesthesia, the patients will receive an endotracheal tube airway device.
Endotracheal Tube Device: Endotracheal tube airway will be used as an airway device for Cohort B in the standard fashion.
|
|---|---|---|
|
Overall Study
Surgery was not performed laparoscopically
|
4
|
2
|
|
Overall Study
Surgery not performed (hernia not identified on diagnostic laparoscopy)
|
0
|
3
|
|
Overall Study
Did not receive allocated intervention (Patient received ETT per surgeon)
|
1
|
0
|
|
Overall Study
Did not received allocated intervention (no airway device documented in EMR)
|
1
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Cohort A: Receives Laryngeal Mask Airway Device
n=25 Participants
In this study arm, after induction of general anesthesia, the patients will receive a laryngeal mask airway device.
Laryngeal Mask Airway: Laryngeal mask airway will be used as an airway device for Cohort A in the standard fashion.
|
Cohort B: Receives Endotracheal Tube Device
n=25 Participants
In this arm, after induction of general anesthesia, the patients will receive an endotracheal tube airway device.
Endotracheal Tube Device: Endotracheal tube airway will be used as an airway device for Cohort B in the standard fashion.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
25 Participants
n=25 Participants
|
25 Participants
n=25 Participants
|
50 Participants
n=50 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
|
Age, Continuous
|
3.5 years
n=25 Participants
|
3.1 years
n=25 Participants
|
3.21 years
n=50 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=25 Participants
|
6 Participants
n=25 Participants
|
13 Participants
n=50 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=25 Participants
|
19 Participants
n=25 Participants
|
37 Participants
n=50 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
25 participants
n=25 Participants
|
25 participants
n=25 Participants
|
50 participants
n=50 Participants
|
PRIMARY outcome
Timeframe: Patients will have oxygen saturation measured directly after placement airway device, the first oxygen saturation recorded five minutes after the start of surgery, and immediately prior to removal airway device, assessed up to 2 hours.Oyxgen saturation will be measured by pulse oximetry in percent saturation at three time points during the anesthetic
Outcome measures
| Measure |
Cohort A: Receives Laryngeal Mask Airway Device
n=25 Participants
In this study arm, after induction of general anesthesia, the patients will receive a laryngeal mask airway device.
Laryngeal Mask Airway: Laryngeal mask airway will be used as an airway device for Cohort A in the standard fashion.
|
Cohort B: Receives Endotracheal Tube Device
n=25 Participants
In this arm, after induction of general anesthesia, the patients will receive an endotracheal tube airway device.
Endotracheal Tube Device: Endotracheal tube airway will be used as an airway device for Cohort B in the standard fashion.
|
|---|---|---|
|
Oxygen Saturation Measured by Pulse Oximetry in Percent Saturation
SpO2 after placement airway device
|
100 Percent Saturation
Interval 100.0 to 100.0
|
100 Percent Saturation
Interval 99.0 to 100.0
|
|
Oxygen Saturation Measured by Pulse Oximetry in Percent Saturation
SpO2 5 minutes after surgery start
|
100 Percent Saturation
Interval 100.0 to 100.0
|
100 Percent Saturation
Interval 99.0 to 100.0
|
|
Oxygen Saturation Measured by Pulse Oximetry in Percent Saturation
SpO2 prior to airway device removal
|
100 Percent Saturation
Interval 100.0 to 100.0
|
100 Percent Saturation
Interval 99.0 to 100.0
|
SECONDARY outcome
Timeframe: Patients will have end-tidal carbon dioxide measured directly after placement of device, the first end-tidal carbon dioxide measurement recorded five minutes after the start of surgery, and immediately prior to removal of device, assessed up to 2 hours.Patients will have end-tidal carbon dioxide measured by capnography in mm Hg at three standardized time points during anesthesia.
Outcome measures
| Measure |
Cohort A: Receives Laryngeal Mask Airway Device
n=25 Participants
In this study arm, after induction of general anesthesia, the patients will receive a laryngeal mask airway device.
Laryngeal Mask Airway: Laryngeal mask airway will be used as an airway device for Cohort A in the standard fashion.
|
Cohort B: Receives Endotracheal Tube Device
n=25 Participants
In this arm, after induction of general anesthesia, the patients will receive an endotracheal tube airway device.
Endotracheal Tube Device: Endotracheal tube airway will be used as an airway device for Cohort B in the standard fashion.
|
|---|---|---|
|
End-tidal Carbon Dioxide Measured by Capnography in mm Hg
ETCO2 prior to removal of airway device
|
45 millimeters mercury (mm Hg)
Interval 43.0 to 53.0
|
49 millimeters mercury (mm Hg)
Interval 43.0 to 57.0
|
|
End-tidal Carbon Dioxide Measured by Capnography in mm Hg
ETCO2 after placement of airway device
|
44 millimeters mercury (mm Hg)
Interval 39.0 to 50.0
|
43 millimeters mercury (mm Hg)
Interval 41.0 to 48.0
|
|
End-tidal Carbon Dioxide Measured by Capnography in mm Hg
ETCO2 5 minutes after surgery start
|
47 millimeters mercury (mm Hg)
Interval 43.0 to 49.0
|
48 millimeters mercury (mm Hg)
Interval 42.0 to 50.0
|
SECONDARY outcome
Timeframe: Patients will have peak airway pressure measured directly after placement airway device, the first airway pressure recorded five minutes after the start of surgery, and immediately prior to removal airway device, assessed up to 2 hours.Patients will have peak airway pressure in cm H2O measured at three standardized time points during anesthesia.
Outcome measures
| Measure |
Cohort A: Receives Laryngeal Mask Airway Device
n=25 Participants
In this study arm, after induction of general anesthesia, the patients will receive a laryngeal mask airway device.
Laryngeal Mask Airway: Laryngeal mask airway will be used as an airway device for Cohort A in the standard fashion.
|
Cohort B: Receives Endotracheal Tube Device
n=25 Participants
In this arm, after induction of general anesthesia, the patients will receive an endotracheal tube airway device.
Endotracheal Tube Device: Endotracheal tube airway will be used as an airway device for Cohort B in the standard fashion.
|
|---|---|---|
|
Peak Airway Pressure Will be Measured in cm H2O
Peak airway pressure after placement of airway device
|
11 cm H20
Interval 7.0 to 12.0
|
14 cm H20
Interval 12.0 to 16.0
|
|
Peak Airway Pressure Will be Measured in cm H2O
Peak airway pressure 5 minutes after surgery start
|
13 cm H20
Interval 11.0 to 14.0
|
16 cm H20
Interval 15.0 to 19.0
|
|
Peak Airway Pressure Will be Measured in cm H2O
Peak airway pressure prior to removal of airway device
|
7 cm H20
Interval 1.0 to 11.0
|
11 cm H20
Interval 5.0 to 14.0
|
SECONDARY outcome
Timeframe: Patients will have the occurrence of laryngospasm documented at any time point during the surgery, assessed up to 2 hours.Will document if laryngospasm occurs in both groups at any time during the surgery.
Outcome measures
| Measure |
Cohort A: Receives Laryngeal Mask Airway Device
n=25 Participants
In this study arm, after induction of general anesthesia, the patients will receive a laryngeal mask airway device.
Laryngeal Mask Airway: Laryngeal mask airway will be used as an airway device for Cohort A in the standard fashion.
|
Cohort B: Receives Endotracheal Tube Device
n=25 Participants
In this arm, after induction of general anesthesia, the patients will receive an endotracheal tube airway device.
Endotracheal Tube Device: Endotracheal tube airway will be used as an airway device for Cohort B in the standard fashion.
|
|---|---|---|
|
Documentation of Laryngospasm Occurrence
|
0 Presence of laryngospasm
|
0 Presence of laryngospasm
|
SECONDARY outcome
Timeframe: Patients will have the occurrence of oxygen desaturation documented if it occurs at any time point during the surgery, assessed up to 2 hours.Will document if oxygen desaturation occurs at any time during the surgery as defined as an oxygen saturation of less than 90%.
Outcome measures
| Measure |
Cohort A: Receives Laryngeal Mask Airway Device
n=25 Participants
In this study arm, after induction of general anesthesia, the patients will receive a laryngeal mask airway device.
Laryngeal Mask Airway: Laryngeal mask airway will be used as an airway device for Cohort A in the standard fashion.
|
Cohort B: Receives Endotracheal Tube Device
n=25 Participants
In this arm, after induction of general anesthesia, the patients will receive an endotracheal tube airway device.
Endotracheal Tube Device: Endotracheal tube airway will be used as an airway device for Cohort B in the standard fashion.
|
|---|---|---|
|
Documentation of Oxygen Desaturation
|
1 Occurence of oxygen desaturation
|
1 Occurence of oxygen desaturation
|
Adverse Events
Cohort A: Receives Laryngeal Mask Airway Device
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort B: Receives Endotracheal Tube Device
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
Dr. Emily Weisberg, pediatric anesthesiologist
Children's Mercy Kansas City
Phone: 9136605813
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place