A Comparison of Different Ventilation Strategies in Children Using the Proseal™ Laryngeal Mask Airway

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Comparison of Different Ventilation Strategies in Children Using the Proseal™ Laryngeal Mask Airway

Conditions
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Intraoperative Ventilation

Intervention / Treatment
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* Procedure: Spontaneous ventilation
* Device: Pressure support Ventilation
* Device: Pressure control ventilation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spontaneous ventilation<br>Pt's will be allowed to breathe spontaneously through the PLMA during surgery without the assistance of positive pressure ventilation. | Procedure: Spontaneous ventilation<br>* The patient will breathe spontaneously (on their own)while under general anesthesia throughout the duration of the surgery.<br>|
| Experimental: Pressure support ventilation<br>Pt's will receive positive pressure assistance with each spontaneous breath through the PLMA. | Device: Pressure support Ventilation<br>* 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.<br>|
| Active Comparator: Pressure control ventilation<br>Pt.'s will be placed on the ventilator and ventilated with pressure control. through the PLMA. | Device: Pressure control ventilation<br>* The patient's ventilation will be completely supported by the anesthesia machine while under general anesthesia throughout the duration of the surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | up to 90 minutes | 
| 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 | up to 90 minutes | 
| Mean Values of ETCO2 in SV and PCV Groups | Mean Values of ETCO2 in SV and PCV groups reported in mmHg | up to 90 minutes | 
| Mean Tidal Volume Values Compared Between SV and PCV Groups | Mean Tidal Volume Values compared between SV and PCV Groups. Measured in mL/kg | up to 90 minutes | 
| Mean Values of ETCO2 Between the PSV and PCV Groups | Mean Values of ETCO2 between the PSV and PCV Groups. Measured in mmHg | up to 90 minutes | 
| 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 | up to 90 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | up to 90 minutes | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Proseal™ LMA, children, ventilation, general anesthesia, Children under general anesthesia for outpatient surgery