A Comparison of Different Ventilation Strategies in Children Using the Proseal™ Laryngeal Mask Airway
- Conditions
- Intraoperative Ventilation
- Interventions
- Device: Pressure control ventilationProcedure: Spontaneous ventilationDevice: Pressure support Ventilation
- Registration Number
- NCT00966433
- Lead Sponsor
- Wake Forest University Health Sciences
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pressure control ventilation Pressure control ventilation Pt.'s will be placed on the ventilator and ventilated with pressure control. through the PLMA. Spontaneous ventilation Spontaneous ventilation Pt's will be allowed to breathe spontaneously through the PLMA during surgery without the assistance of positive pressure ventilation. Pressure support ventilation Pressure support Ventilation Pt's will receive positive pressure assistance with each spontaneous breath through the PLMA.
- Primary Outcome Measures
Name Time Method 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
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
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
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
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
- Secondary Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States