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Completed

NCT Number: NCT00966433

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

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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Key information

Age range

12 month–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spontaneous ventilation

Procedure

The patient will breathe spontaneously (on their own)while under general anesthesia throughout the duration of the surgery.

Pressure support ventilation

Device

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.

Pressure control ventilation

Device

The patient's ventilation will be completely supported by the anesthesia machine while under general anesthesia throughout the duration of the surgery.

Primary outcomes

  1. Differences in End-tidal Carbon Dioxide Compared Between the Spontaneous Ventilation and Pressure Support Ventilation Groups.

    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

  2. Differences Tidal Volume Compared Between the Spontaneous Ventilation and Pressure Support Ventilation Groups.

    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

  3. Mean Values of ETCO2 in SV and PCV Groups

    Time frame: up to 90 minutes

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

  4. Mean Tidal Volume Values Compared Between SV and PCV Groups

    Time frame: up to 90 minutes

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

  5. Mean Values of ETCO2 Between the PSV and PCV Groups

    Time frame: up to 90 minutes

    Mean Values of ETCO2 between the PSV and PCV Groups. Measured in mmHg

  6. Mean Values of Tidal Volume Between the PSV and PCV Groups

    Time frame: up to 90 minutes

    Mean Values of Tidal Volume Between the PSV and PCV Groups. Measured in mL/kg

Secondary outcomes

  1. Differences in Respiratory Rates Between Spontaneous Ventilation and Pressure Support Ventilation Groups.

    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.

  2. Mean Values of Respiratory Rate Compared Between the Spontaneous Ventilation and Pressure Control Ventilation Groups.

    Time frame: up to 90 minutes

  3. Mean Values of Respiratory Rate Compared Between Pressure Support Ventilation and Pressure Control Ventilation Groups.

    Time frame: up to 90 minutes

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Aug 27, 2009
Registry last updated
Dec 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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