NCT03235817

A Comparison of Different Ventilation Strategies in Infants Using the PLMA™

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Wake Forest University · Academic / Other
• Sex: All
• Age: 1 Month – 11 Months
• Healthy volunteers: Not accepted

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 infants under general anesthesia. Hypothesis: Infants undergoing general anesthesia with a PLMA™ will be better ventilated (improved breathing) with the help of the breathing machine versus breathing on their own.

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™ laryngeal mask airway (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. Infants under GA may breathe through a PLMA in different ways. Spontaneous ventilation consists of the infants 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. An infant undergoing surgery requires a deep level of general anesthesia which negatively affects their ability to ventilate. Thus, infants 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 infants undergoing outpatient surgery.

Conditions

• Ventilation

Interventions

Type	Name	Description
OTHER	Spontaneous ventilation	The patient will breathe spontaneously (on their own) while under general anesthesia throughout the duration of the surgery.
DEVICE	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.
DEVICE	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.

Timeline

• Start date: 2009-12-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2017-08-01
• Last updated: 2022-03-18
• Results posted: 2018-01-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study