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

Not Applicable
Completed
Conditions
Intraoperative Ventilation
Interventions
Device: Pressure control ventilation
Procedure: Spontaneous ventilation
Device: 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
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Pressure control ventilationPressure control ventilationPt.'s will be placed on the ventilator and ventilated with pressure control. through the PLMA.
Spontaneous ventilationSpontaneous ventilationPt's will be allowed to breathe spontaneously through the PLMA during surgery without the assistance of positive pressure ventilation.
Pressure support ventilationPressure support VentilationPt's will receive positive pressure assistance with each spontaneous breath through the PLMA.
Primary Outcome Measures
NameTimeMethod
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 Groupsup 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 Groupsup 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 Groupsup to 90 minutes

Mean Values of ETCO2 in SV and PCV groups reported in mmHg

Mean Tidal Volume Values Compared Between SV and PCV Groupsup to 90 minutes

Mean Tidal Volume Values compared between SV and PCV Groups. Measured in mL/kg

Secondary Outcome Measures
NameTimeMethod
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

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