Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
NCT Number: NCT00966433
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.
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Notify Me12 month–5 year
All sexes
Interventional
Not applicable
Winston-Salem, North Carolina, 27157, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The patient will breathe spontaneously (on their own)while under general anesthesia throughout the duration of the surgery.
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.
The patient's ventilation will be completely supported by the anesthesia machine while under general anesthesia throughout the duration of the surgery.
Time frame: 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
Time frame: 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
Time frame: up to 90 minutes
Mean Values of ETCO2 in SV and PCV groups reported in mmHg
Time frame: up to 90 minutes
Mean Tidal Volume Values compared between SV and PCV Groups. Measured in mL/kg
Time frame: up to 90 minutes
Mean Values of ETCO2 between the PSV and PCV Groups. Measured in mmHg
Time frame: up to 90 minutes
Mean Values of Tidal Volume Between the PSV and PCV Groups. Measured in mL/kg
Time frame: 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.
Time frame: up to 90 minutes
Time frame: up to 90 minutes
Wake Forest University Health Sciences
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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