Trial Outcomes & Findings for A Comparison of Different Ventilation Strategies in Infants Using the PLMA™ (NCT NCT03235817)
NCT ID: NCT03235817
Last Updated: 2022-03-18
Results Overview
Mean values of end-tidal carbon dioxide (ETCO2) and tidal volume (TV) between 5 and 45 minutes compared between the spontaneous ventilation (SV) and pressure support ventilation groups (PSV).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
39 participants
Primary outcome timeframe
Up to 45 minutes
Results posted on
2022-03-18
Participant Flow
Participant milestones
| Measure |
Spontaneous Ventilation
Spontaneous ventilation: The patient will breathe spontaneously (on their own) while under general anesthesia throughout the duration of the surgery.
|
Pressure Support Ventilation
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
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
|
13
|
13
|
13
|
|
Overall Study
COMPLETED
|
10
|
12
|
11
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Comparison of Different Ventilation Strategies in Infants Using the PLMA™
Baseline characteristics by cohort
| Measure |
Spontaneous Ventilation
n=10 Participants
Spontaneous ventilation: The patient will breathe spontaneously (on their own) while under general anesthesia throughout the duration of the surgery.
|
Pressure Support Ventilation
n=12 Participants
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
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=33 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
Age
|
7.1 months
STANDARD_DEVIATION 2 • n=5 Participants
|
7.3 months
STANDARD_DEVIATION 2 • n=7 Participants
|
6.9 months
STANDARD_DEVIATION 1.9 • n=5 Participants
|
7.1 months
STANDARD_DEVIATION 2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Weight
|
8 kg
STANDARD_DEVIATION 1.7 • n=5 Participants
|
8.5 kg
STANDARD_DEVIATION .9 • n=7 Participants
|
8.2 kg
STANDARD_DEVIATION 1.3 • n=5 Participants
|
8.2 kg
STANDARD_DEVIATION 1.4 • n=4 Participants
|
|
PLMA Size (ProSeal laryngeal mask airway)
Size 1.5
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
PLMA Size (ProSeal laryngeal mask airway)
Size 2
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Induction Time
|
9.5 minutes
STANDARD_DEVIATION 5.9 • n=5 Participants
|
8.6 minutes
STANDARD_DEVIATION 3.3 • n=7 Participants
|
9.6 minutes
STANDARD_DEVIATION 3.1 • n=5 Participants
|
9.2 minutes
STANDARD_DEVIATION 4.3 • n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 45 minutesMean values of end-tidal carbon dioxide (ETCO2) and tidal volume (TV) between 5 and 45 minutes compared between the spontaneous ventilation (SV) and pressure support ventilation groups (PSV).
Outcome measures
| Measure |
Spontaneous Ventilation
n=10 Participants
Spontaneous ventilation: The patient will breathe spontaneously (on their own) while under general anesthesia throughout the duration of the surgery.
|
Pressure Support Ventilation
n=12 Participants
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.
|
|---|---|---|
|
Mean Values of End-tidal Carbon Dioxide and Tidal Volume Compared Between the Spontaneous Ventilation and Pressure Support Ventilation Groups.
Mean Values of Tidal Volume
|
4.5 cc/kg
Standard Deviation .3
|
7 cc/kg
Standard Deviation .5
|
|
Mean Values of End-tidal Carbon Dioxide and Tidal Volume Compared Between the Spontaneous Ventilation and Pressure Support Ventilation Groups.
Mean Values of End-Tidal Carbon Dioxide
|
51.8 cc/kg
Standard Deviation 2.9
|
49 cc/kg
Standard Deviation 1.5
|
PRIMARY outcome
Timeframe: Up to 45 minutesMean values of ETCO2 and TV between 5 and 45 minutes compared between the SV and Pressure control ventilation (PCV) groups.
Outcome measures
| Measure |
Spontaneous Ventilation
n=10 Participants
Spontaneous ventilation: The patient will breathe spontaneously (on their own) while under general anesthesia throughout the duration of the surgery.
|
Pressure Support Ventilation
n=11 Participants
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.
|
|---|---|---|
|
Mean Values of ETCO2 and TV Compared Between the SV and PCV Groups
TV
|
4.5 cc/kg
Standard Deviation 0.3
|
7.0 cc/kg
Standard Deviation 0.4
|
|
Mean Values of ETCO2 and TV Compared Between the SV and PCV Groups
ETCO2
|
51.8 cc/kg
Standard Deviation 2.9
|
48.3 cc/kg
Standard Deviation 1.6
|
PRIMARY outcome
Timeframe: up to 45 minutesMean values of ETCO2 and TV between 5 and 45 minutes compared between the PSV and PCV groups
Outcome measures
| Measure |
Spontaneous Ventilation
n=12 Participants
Spontaneous ventilation: The patient will breathe spontaneously (on their own) while under general anesthesia throughout the duration of the surgery.
|
Pressure Support Ventilation
n=11 Participants
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.
|
|---|---|---|
|
Mean Values of ETCO2 and TV Compared Between the PSV and PCV Groups
ETCO2
|
49.0 cc/kg
Standard Deviation 1.5
|
48.3 cc/kg
Standard Deviation 1.6
|
|
Mean Values of ETCO2 and TV Compared Between the PSV and PCV Groups
TV
|
7.0 cc/kg
Standard Deviation 0.5
|
7.0 cc/kg
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: Up to 45 minutesMean values of respiratory rate between 5 and 45 minutes compared between spontaneous ventilation and pressure support ventilation groups.
Outcome measures
| Measure |
Spontaneous Ventilation
n=10 Participants
Spontaneous ventilation: The patient will breathe spontaneously (on their own) while under general anesthesia throughout the duration of the surgery.
|
Pressure Support Ventilation
n=12 Participants
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.
|
|---|---|---|
|
Mean Values of Respiratory Rates Between Spontaneous Ventilation and Pressure Support Ventilation Groups.
|
32.2 breaths per minute
Standard Deviation 2.2
|
25.1 breaths per minute
Standard Deviation .8
|
SECONDARY outcome
Timeframe: Up to 45 minutesMean values of respiratory rate between 5 and 45 minutes compared between the spontaneous ventilation and pressure control ventilation groups.
Outcome measures
| Measure |
Spontaneous Ventilation
n=10 Participants
Spontaneous ventilation: The patient will breathe spontaneously (on their own) while under general anesthesia throughout the duration of the surgery.
|
Pressure Support Ventilation
n=11 Participants
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.
|
|---|---|---|
|
Mean Values of Respiratory Rate Compared Between the Spontaneous Ventilation and Pressure Control Ventilation Groups.
|
32.2 breaths per minute
Standard Deviation 2.2
|
22.3 breaths per minute
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: Up to 45 minutesMean values of respiratory rate between 5 and 45 minutes compared between pressure support ventilation and pressure control ventilation groups.
Outcome measures
| Measure |
Spontaneous Ventilation
n=12 Participants
Spontaneous ventilation: The patient will breathe spontaneously (on their own) while under general anesthesia throughout the duration of the surgery.
|
Pressure Support Ventilation
n=11 Participants
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.
|
|---|---|---|
|
Mean Values of Respiratory Rate Compared Between Pressure Support Ventilation and Pressure Control Ventilation Groups.
|
25.1 breaths per minute
Standard Deviation .8
|
22.3 breaths per minute
Standard Deviation 1.2
|
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place