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Completed

NCT Number: NCT03235817

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

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.

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Key information

Conditions

Ventilation Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases

Age range

1 month–11 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest Baptist Health

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™ 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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ASA (American Society of Anesthesiologists) physical classification of 1 or 2
  • Outpatient surgical procedures
  • Surgical procedure anticipated to be < 90 minutes
  • Subject age of 1 - 11 months (inclusive)

Exclusion criteria

  • Inpatient- Such individuals may have underlying disease processes which puts them at an increased risk under general anesthesia for hypoventilation
  • ASA physical classification of 3, 4 or E
  • Premature infants or infants < 44 weeks post-conceptual age
  • Risk of aspiration- Intubation with an endotracheal tube may be required for general anesthesia.
  • Patients with malignant hyperthermia or family history of malignant hyperthermia- Administration of inhalational agents for general anesthesia is contraindicated.
  • Patients with tracheostomies- The individual's airway is already established and PLMA™ placement is not required.

Treatment and study plan

Spontaneous ventilation

Other

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. Mean Values of End-tidal Carbon Dioxide and Tidal Volume Compared Between the Spontaneous Ventilation and Pressure Support Ventilation Groups.

    Time frame: Up to 45 minutes

    Mean values of end-tidal carbon dioxide (ETCO2) and tidal volume (TV) between 5 and 45 minutes compared between the spontaneous ventilation (SV) and pressure support ventilation groups (PSV).

  2. Mean Values of ETCO2 and TV Compared Between the SV and PCV Groups

    Time frame: Up to 45 minutes

    Mean values of ETCO2 and TV between 5 and 45 minutes compared between the SV and Pressure control ventilation (PCV) groups.

  3. Mean Values of ETCO2 and TV Compared Between the PSV and PCV Groups

    Time frame: up to 45 minutes

    Mean values of ETCO2 and TV between 5 and 45 minutes compared between the PSV and PCV groups

Secondary outcomes

  1. Mean Values of Respiratory Rates Between Spontaneous Ventilation and Pressure Support Ventilation Groups.

    Time frame: Up to 45 minutes

    Mean values of respiratory rate between 5 and 45 minutes compared between spontaneous ventilation and pressure support ventilation groups.

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

    Time frame: Up to 45 minutes

    Mean values of respiratory rate between 5 and 45 minutes compared between the spontaneous ventilation and pressure control ventilation groups.

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

    Time frame: Up to 45 minutes

    Mean values of respiratory rate between 5 and 45 minutes compared between pressure support ventilation and pressure control ventilation groups.

Sponsors and collaborators

Lead sponsor

Wake Forest University

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Aug 1, 2017
Registry last updated
Mar 18, 2022

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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