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

Wake Forest University (WFU)

Status: Completed

Conditions: Intraoperative Ventilation

Treatments: Device: Pressure support Ventilation; Procedure: Spontaneous ventilation; Device: Pressure control ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT00966433

IRB00009452

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 12 months to 5 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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33 participants in 3 patient groups

Spontaneous ventilation

Experimental group

Description:

Pt's will be allowed to breathe spontaneously through the PLMA during surgery without the assistance of positive pressure ventilation.

Treatment:

Procedure: Spontaneous ventilation

Pressure support ventilation

Experimental group

Description:

Pt's will receive positive pressure assistance with each spontaneous breath through the PLMA.

Treatment:

Device: Pressure support Ventilation

Pressure control ventilation

Active Comparator group

Description:

Pt.'s will be placed on the ventilator and ventilated with pressure control. through the PLMA.

Treatment:

Device: Pressure control ventilation