Trial Outcomes & Findings for A Comparison of Different Ventilation Strategies in Children Using the Proseal™ Laryngeal Mask Airway (NCT NCT00966433)
NCT ID: NCT00966433
Last Updated: 2018-12-05
Results Overview
Differences in End-tidal Carbon Dioxide Compared Between the Spontaneous Ventilation and Pressure Support Ventilation Groups will be calculated by subtracting the mean of End-tidal Carbon Dioxide from the PSV group to the SV group
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
33 participants
Primary outcome timeframe
up to 90 minutes
Results posted on
2018-12-05
Participant Flow
Participant milestones
| Measure |
Spontaneous Ventilation
Pt's will be allowed to breathe spontaneously through the PLMA during surgery without the assistance of positive pressure ventilation.
Spontaneous ventilation: The patient will breathe spontaneously (on their own)while under general anesthesia throughout the duration of the surgery.
|
Pressure Support Ventilation
Pt's will receive positive pressure assistance with each spontaneous breath through the PLMA.
Pressure support Ventilation: The patient will breathe on their own and with a little assistance from the anesthesia machine while under general anesthesia throughout the duration of the surgery.
|
Pressure Control Ventilation
Pt.'s will be placed on the ventilator and ventilated with pressure control. through the PLMA.
Pressure control ventilation: The patient's ventilation will be completely supported by the anesthesia machine while under general anesthesia throughout the duration of the surgery.
|
|---|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
11
|
|
Overall Study
COMPLETED
|
10
|
10
|
11
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Comparison of Different Ventilation Strategies in Children Using the Proseal™ Laryngeal Mask Airway
Baseline characteristics by cohort
| Measure |
Spontaneous Ventilation
n=10 Participants
Pt's will be allowed to breathe spontaneously through the PLMA during surgery without the assistance of positive pressure ventilation.
Spontaneous ventilation: The patient will breathe spontaneously (on their own)while under general anesthesia throughout the duration of the surgery.
|
Pressure Support Ventilation
n=10 Participants
Pt's will receive positive pressure assistance with each spontaneous breath through the PLMA.
Pressure support Ventilation: The patient will breathe on their own and with a little assistance from the anesthesia machine while under general anesthesia throughout the duration of the surgery.
|
Pressure Control Ventilation
n=11 Participants
Pt.'s will be placed on the ventilator and ventilated with pressure control. through the PLMA.
Pressure control ventilation: The patient's ventilation will be completely supported by the anesthesia machine while under general anesthesia throughout the duration of the surgery.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
28 Months
STANDARD_DEVIATION 18 • n=99 Participants
|
32 Months
STANDARD_DEVIATION 17 • n=107 Participants
|
27 Months
STANDARD_DEVIATION 16 • n=206 Participants
|
28.9 Months
STANDARD_DEVIATION 17.01 • n=7 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
28 Participants
n=7 Participants
|
|
ASA Status
I
|
9 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
26 Participants
n=7 Participants
|
|
ASA Status
II
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: up to 90 minutesDifferences in End-tidal Carbon Dioxide Compared Between the Spontaneous Ventilation and Pressure Support Ventilation Groups will be calculated by subtracting the mean of End-tidal Carbon Dioxide from the PSV group to the SV group
Outcome measures
| Measure |
Pressure Support Ventilation
n=10 Participants
Pt's will receive positive pressure assistance with each spontaneous breath through the PLMA.
Pressure support Ventilation: The patient will breathe on their own and with a little assistance from the anesthesia machine while under general anesthesia throughout the duration of the surgery.
|
Spontaneous Ventilation
n=10 Participants
Pt's will be allowed to breathe spontaneously through the PLMA during surgery without the assistance of positive pressure ventilation.
Spontaneous ventilation: The patient will breathe spontaneously (on their own)while under general anesthesia throughout the duration of the surgery.
|
|---|---|---|
|
Differences in End-tidal Carbon Dioxide Compared Between the Spontaneous Ventilation and Pressure Support Ventilation Groups.
|
47 mmHg
Standard Deviation 6
|
55.2 mmHg
Standard Deviation 5.5
|
PRIMARY outcome
Timeframe: up to 90 minutesTidal Volume Compared Between the Spontaneous Ventilation and Pressure Support Ventilation Groups. Measured in mL/Kg and will be calculated by subtracting the mean of tidal volume from the PSV group to the SV group
Outcome measures
| Measure |
Pressure Support Ventilation
n=10 Participants
Pt's will receive positive pressure assistance with each spontaneous breath through the PLMA.
Pressure support Ventilation: The patient will breathe on their own and with a little assistance from the anesthesia machine while under general anesthesia throughout the duration of the surgery.
|
Spontaneous Ventilation
n=10 Participants
Pt's will be allowed to breathe spontaneously through the PLMA during surgery without the assistance of positive pressure ventilation.
Spontaneous ventilation: The patient will breathe spontaneously (on their own)while under general anesthesia throughout the duration of the surgery.
|
|---|---|---|
|
Differences Tidal Volume Compared Between the Spontaneous Ventilation and Pressure Support Ventilation Groups.
|
7.6 mL/kg
Standard Deviation .5
|
4.0 mL/kg
Standard Deviation .8
|
PRIMARY outcome
Timeframe: up to 90 minutesMean Values of ETCO2 in SV and PCV groups reported in mmHg
Outcome measures
| Measure |
Pressure Support Ventilation
n=11 Participants
Pt's will receive positive pressure assistance with each spontaneous breath through the PLMA.
Pressure support Ventilation: The patient will breathe on their own and with a little assistance from the anesthesia machine while under general anesthesia throughout the duration of the surgery.
|
Spontaneous Ventilation
n=10 Participants
Pt's will be allowed to breathe spontaneously through the PLMA during surgery without the assistance of positive pressure ventilation.
Spontaneous ventilation: The patient will breathe spontaneously (on their own)while under general anesthesia throughout the duration of the surgery.
|
|---|---|---|
|
Mean Values of ETCO2 in SV and PCV Groups
|
43.1 mmHg
Standard Deviation 0.8
|
55.2 mmHg
Standard Deviation 5.5
|
PRIMARY outcome
Timeframe: up to 90 minutesMean Tidal Volume Values compared between SV and PCV Groups. Measured in mL/kg
Outcome measures
| Measure |
Pressure Support Ventilation
n=11 Participants
Pt's will receive positive pressure assistance with each spontaneous breath through the PLMA.
Pressure support Ventilation: The patient will breathe on their own and with a little assistance from the anesthesia machine while under general anesthesia throughout the duration of the surgery.
|
Spontaneous Ventilation
n=10 Participants
Pt's will be allowed to breathe spontaneously through the PLMA during surgery without the assistance of positive pressure ventilation.
Spontaneous ventilation: The patient will breathe spontaneously (on their own)while under general anesthesia throughout the duration of the surgery.
|
|---|---|---|
|
Mean Tidal Volume Values Compared Between SV and PCV Groups
|
7.6 mL/kg
Standard Deviation 0.2
|
4.0 mL/kg
Standard Deviation 0.8
|
PRIMARY outcome
Timeframe: up to 90 minutesMean Values of ETCO2 between the PSV and PCV Groups. Measured in mmHg
Outcome measures
| Measure |
Pressure Support Ventilation
n=11 Participants
Pt's will receive positive pressure assistance with each spontaneous breath through the PLMA.
Pressure support Ventilation: The patient will breathe on their own and with a little assistance from the anesthesia machine while under general anesthesia throughout the duration of the surgery.
|
Spontaneous Ventilation
n=10 Participants
Pt's will be allowed to breathe spontaneously through the PLMA during surgery without the assistance of positive pressure ventilation.
Spontaneous ventilation: The patient will breathe spontaneously (on their own)while under general anesthesia throughout the duration of the surgery.
|
|---|---|---|
|
Mean Values of ETCO2 Between the PSV and PCV Groups
|
43.1 mmHg
Standard Deviation 0.8
|
47.0 mmHg
Standard Deviation 6.0
|
PRIMARY outcome
Timeframe: up to 90 minutesMean Values of Tidal Volume Between the PSV and PCV Groups. Measured in mL/kg
Outcome measures
| Measure |
Pressure Support Ventilation
n=11 Participants
Pt's will receive positive pressure assistance with each spontaneous breath through the PLMA.
Pressure support Ventilation: The patient will breathe on their own and with a little assistance from the anesthesia machine while under general anesthesia throughout the duration of the surgery.
|
Spontaneous Ventilation
n=10 Participants
Pt's will be allowed to breathe spontaneously through the PLMA during surgery without the assistance of positive pressure ventilation.
Spontaneous ventilation: The patient will breathe spontaneously (on their own)while under general anesthesia throughout the duration of the surgery.
|
|---|---|---|
|
Mean Values of Tidal Volume Between the PSV and PCV Groups
|
7.6 mL/kg
Standard Deviation 0.2
|
7.6 mL/kg
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: up to 90 minutesDifferences in respiratory rates between spontaneous ventilation and pressure support ventilation groups will be calculated by subtracting the mean of from the respiratory rates PSV group to the SV group.
Outcome measures
| Measure |
Pressure Support Ventilation
n=10 Participants
Pt's will receive positive pressure assistance with each spontaneous breath through the PLMA.
Pressure support Ventilation: The patient will breathe on their own and with a little assistance from the anesthesia machine while under general anesthesia throughout the duration of the surgery.
|
Spontaneous Ventilation
n=10 Participants
Pt's will be allowed to breathe spontaneously through the PLMA during surgery without the assistance of positive pressure ventilation.
Spontaneous ventilation: The patient will breathe spontaneously (on their own)while under general anesthesia throughout the duration of the surgery.
|
|---|---|---|
|
Differences in Respiratory Rates Between Spontaneous Ventilation and Pressure Support Ventilation Groups.
|
14.2 breath/min
Standard Deviation 5.3
|
28.1 breath/min
Standard Deviation 5.3
|
SECONDARY outcome
Timeframe: up to 90 minutesOutcome measures
| Measure |
Pressure Support Ventilation
n=11 Participants
Pt's will receive positive pressure assistance with each spontaneous breath through the PLMA.
Pressure support Ventilation: The patient will breathe on their own and with a little assistance from the anesthesia machine while under general anesthesia throughout the duration of the surgery.
|
Spontaneous Ventilation
n=10 Participants
Pt's will be allowed to breathe spontaneously through the PLMA during surgery without the assistance of positive pressure ventilation.
Spontaneous ventilation: The patient will breathe spontaneously (on their own)while under general anesthesia throughout the duration of the surgery.
|
|---|---|---|
|
Mean Values of Respiratory Rate Compared Between the Spontaneous Ventilation and Pressure Control Ventilation Groups.
|
21.2 breath/min
Standard Deviation 3.0
|
28.1 breath/min
Standard Deviation 5.3
|
SECONDARY outcome
Timeframe: up to 90 minutesOutcome measures
| Measure |
Pressure Support Ventilation
n=11 Participants
Pt's will receive positive pressure assistance with each spontaneous breath through the PLMA.
Pressure support Ventilation: The patient will breathe on their own and with a little assistance from the anesthesia machine while under general anesthesia throughout the duration of the surgery.
|
Spontaneous Ventilation
n=10 Participants
Pt's will be allowed to breathe spontaneously through the PLMA during surgery without the assistance of positive pressure ventilation.
Spontaneous ventilation: The patient will breathe spontaneously (on their own)while under general anesthesia throughout the duration of the surgery.
|
|---|---|---|
|
Mean Values of Respiratory Rate Compared Between Pressure Support Ventilation and Pressure Control Ventilation Groups.
|
21.2 breath/min
Standard Deviation 3.0
|
14.2 breath/min
Standard Deviation 5.3
|
Adverse Events
Spontaneous Ventilation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pressure Support Ventilation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pressure Control Ventilation
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. Thomas Templeton, MD
Wake Forest University Health Sciences
Phone: 336-716-4285
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place