Intraoperative Ventilation
Conditions
Keywords
Proseal™ LMA, children, ventilation, general anesthesia, Children under general anesthesia for outpatient surgery
Brief summary
The purpose of this research study is to compare difference between breathing by oneself or with the partial help from an anesthesia machine in children under general anesthesia.
Detailed description
The laryngeal mask airway (LMA) is a breathing device that sits above the vocal cords and allows the patient to breathe in and out adequately under general anesthesia (GA). The ProSeal™ LMA (PLMA™) is a specialized type of LMA with a design that permits the delivery of higher pressures to help the patient breathe in and out (ventilate) and also contains a channel to suction the stomach. Children under GA may breathe through a PLMA in different ways. Spontaneous ventilation consists of the children breathing on their own through a PLMA™. Pressure support ventilation allows the patient to breathe on their own with additional help from the anesthesia machine. Pressure control ventilation allows the patient to breathe with the help of an anesthesia machine. A child undergoing surgery requires a deep level of general anesthesia which negatively affects their ability to ventilate. Thus, children may not breathe in oxygen and carbon dioxide out adequately at this level of anesthesia and it may be beneficial to provide some level of support to enhance carbon dioxide exchange and to avoid hypoventilation. This study will attempt to determine whether pressure support ventilation improves ventilation in children undergoing outpatient surgery.
Interventions
The patient's ventilation will be completely supported by the anesthesia machine while under general anesthesia throughout the duration of the surgery.
PROCEDURESpontaneous ventilation
The patient will breathe spontaneously (on their own)while under general anesthesia throughout the duration of the surgery.
DEVICEPressure 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.
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Months to 5 Years
Healthy volunteers
No
Inclusion criteria
* ASA physical classification 1,2 (Healthy or relatively healthy children) * Subjects scheduled for outpatient surgical procedures. * Surgical procedure anticipated to be \< 90 minutes * Subject weight of ≤ 20 kg (44 lbs) * Subject age of 12 months to 5 years (inclusive)
Exclusion criteria
* Inpatient * ASA physical classification of 3, 4 or E (sick children) * Risk of aspiration * Subjects with malignant hyperthermia or family history of malignant hyperthermia * Subjects with tracheostomies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Values of Tidal Volume Between the PSV and PCV Groups | up to 90 minutes | Mean Values of Tidal Volume Between the PSV and PCV Groups. Measured in mL/kg |
| Mean Values of ETCO2 in SV and PCV Groups | up to 90 minutes | Mean Values of ETCO2 in SV and PCV groups reported in mmHg |
| Mean Tidal Volume Values Compared Between SV and PCV Groups | up to 90 minutes | Mean Tidal Volume Values compared between SV and PCV Groups. Measured in mL/kg |
| Mean Values of ETCO2 Between the PSV and PCV Groups | up to 90 minutes | Mean Values of ETCO2 between the PSV and PCV Groups. Measured in mmHg |
| Differences in End-tidal Carbon Dioxide Compared Between the Spontaneous Ventilation and Pressure Support Ventilation Groups. | up to 90 minutes | 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 |
| Differences Tidal Volume Compared Between the Spontaneous Ventilation and Pressure Support Ventilation Groups. | up to 90 minutes | Tidal 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Values of Respiratory Rate Compared Between the Spontaneous Ventilation and Pressure Control Ventilation Groups. | up to 90 minutes | — |
| Mean Values of Respiratory Rate Compared Between Pressure Support Ventilation and Pressure Control Ventilation Groups. | up to 90 minutes | — |
| Differences in Respiratory Rates Between Spontaneous Ventilation and Pressure Support Ventilation Groups. | up to 90 minutes | Differences 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 10 |
| 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. | 10 |
| 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. | 11 |
| Total | 31 |
Baseline characteristics
| Characteristic | Spontaneous Ventilation | Pressure Support Ventilation | Pressure Control Ventilation | Total |
|---|---|---|---|---|
| Age, Continuous | 28 Months STANDARD_DEVIATION 18 | 32 Months STANDARD_DEVIATION 17 | 27 Months STANDARD_DEVIATION 16 | 28.9 Months STANDARD_DEVIATION 17.01 |
| ASA Status I | 9 Participants | 8 Participants | 9 Participants | 26 Participants |
| ASA Status II | 1 Participants | 2 Participants | 2 Participants | 5 Participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Male | 9 Participants | 9 Participants | 10 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 | 0 / 11 |
| other Total, other adverse events | 0 / 10 | 0 / 10 | 0 / 11 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 | 0 / 11 |
Outcome results
Primary
Differences in End-tidal Carbon Dioxide Compared Between the Spontaneous Ventilation and Pressure Support Ventilation Groups.
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
Time frame: up to 90 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spontaneous Ventilation | Differences in End-tidal Carbon Dioxide Compared Between the Spontaneous Ventilation and Pressure Support Ventilation Groups. | 55.2 mmHg | Standard Deviation 5.5 |
| Pressure Support Ventilation | Differences in End-tidal Carbon Dioxide Compared Between the Spontaneous Ventilation and Pressure Support Ventilation Groups. | 47 mmHg | Standard Deviation 6 |
p-value: 0.005195% CI: [-13.61, -2.79]t-test, 2 sided
Primary
Differences Tidal Volume Compared Between the Spontaneous Ventilation and Pressure Support Ventilation Groups.
Tidal 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
Time frame: up to 90 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spontaneous Ventilation | Differences Tidal Volume Compared Between the Spontaneous Ventilation and Pressure Support Ventilation Groups. | 4.0 mL/kg | Standard Deviation 0.8 |
| Pressure Support Ventilation | Differences Tidal Volume Compared Between the Spontaneous Ventilation and Pressure Support Ventilation Groups. | 7.6 mL/kg | Standard Deviation 0.5 |
p-value: 0.000195% CI: [2.97, 4.23]t-test, 2 sided
Primary
Mean Tidal Volume Values Compared Between SV and PCV Groups
Mean Tidal Volume Values compared between SV and PCV Groups. Measured in mL/kg
Time frame: up to 90 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spontaneous Ventilation | Mean Tidal Volume Values Compared Between SV and PCV Groups | 4.0 mL/kg | Standard Deviation 0.8 |
| Pressure Support Ventilation | Mean Tidal Volume Values Compared Between SV and PCV Groups | 7.6 mL/kg | Standard Deviation 0.2 |
Primary
Mean Values of ETCO2 Between the PSV and PCV Groups
Mean Values of ETCO2 between the PSV and PCV Groups. Measured in mmHg
Time frame: up to 90 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spontaneous Ventilation | Mean Values of ETCO2 Between the PSV and PCV Groups | 47.0 mmHg | Standard Deviation 6 |
| Pressure Support Ventilation | Mean Values of ETCO2 Between the PSV and PCV Groups | 43.1 mmHg | Standard Deviation 0.8 |
Primary
Mean Values of ETCO2 in SV and PCV Groups
Mean Values of ETCO2 in SV and PCV groups reported in mmHg
Time frame: up to 90 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spontaneous Ventilation | Mean Values of ETCO2 in SV and PCV Groups | 55.2 mmHg | Standard Deviation 5.5 |
| Pressure Support Ventilation | Mean Values of ETCO2 in SV and PCV Groups | 43.1 mmHg | Standard Deviation 0.8 |
Primary
Mean Values of Tidal Volume Between the PSV and PCV Groups
Mean Values of Tidal Volume Between the PSV and PCV Groups. Measured in mL/kg
Time frame: up to 90 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spontaneous Ventilation | Mean Values of Tidal Volume Between the PSV and PCV Groups | 7.6 mL/kg | Standard Deviation 0.5 |
| Pressure Support Ventilation | Mean Values of Tidal Volume Between the PSV and PCV Groups | 7.6 mL/kg | Standard Deviation 0.2 |
Secondary
Differences in Respiratory Rates Between Spontaneous Ventilation and Pressure Support Ventilation Groups.
Differences 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.
Time frame: up to 90 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spontaneous Ventilation | Differences in Respiratory Rates Between Spontaneous Ventilation and Pressure Support Ventilation Groups. | 28.1 breath/min | Standard Deviation 5.3 |
| Pressure Support Ventilation | Differences in Respiratory Rates Between Spontaneous Ventilation and Pressure Support Ventilation Groups. | 14.2 breath/min | Standard Deviation 5.3 |
p-value: 0.000195% CI: [-18.88, -8.92]t-test, 2 sided
Secondary
Mean Values of Respiratory Rate Compared Between Pressure Support Ventilation and Pressure Control Ventilation Groups.
Time frame: up to 90 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spontaneous Ventilation | Mean Values of Respiratory Rate Compared Between Pressure Support Ventilation and Pressure Control Ventilation Groups. | 14.2 breath/min | Standard Deviation 5.3 |
| Pressure Support Ventilation | Mean Values of Respiratory Rate Compared Between Pressure Support Ventilation and Pressure Control Ventilation Groups. | 21.2 breath/min | Standard Deviation 3 |
Secondary
Mean Values of Respiratory Rate Compared Between the Spontaneous Ventilation and Pressure Control Ventilation Groups.
Time frame: up to 90 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spontaneous Ventilation | Mean Values of Respiratory Rate Compared Between the Spontaneous Ventilation and Pressure Control Ventilation Groups. | 28.1 breath/min | Standard Deviation 5.3 |
| Pressure Support Ventilation | Mean Values of Respiratory Rate Compared Between the Spontaneous Ventilation and Pressure Control Ventilation Groups. | 21.2 breath/min | Standard Deviation 3 |