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

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.

Study Overview

• Status: Completed
• Conditions: Ventilation
• Intervention / Treatment: Other: Spontaneous ventilation; Device: Pressure support ventilation; Device: Pressure control ventilation

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.

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 11 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Spontaneous ventilation	Other: Spontaneous ventilation; The patient will breathe spontaneously (on their own) while under general anesthesia throughout the duration of the surgery.
Experimental: Pressure support ventilation	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.
Active Comparator: Pressure control ventilation	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Values of End-tidal Carbon Dioxide and Tidal Volume Compared Between the Spontaneous Ventilation and Pressure Support Ventilation Groups.	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).	Up to 45 minutes
Mean Values of ETCO2 and TV Compared Between the SV and PCV Groups	Mean values of ETCO2 and TV between 5 and 45 minutes compared between the SV and Pressure control ventilation (PCV) groups.	Up to 45 minutes
Mean Values of ETCO2 and TV Compared Between the PSV and PCV Groups	Mean values of ETCO2 and TV between 5 and 45 minutes compared between the PSV and PCV groups	up to 45 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Values of Respiratory Rates Between Spontaneous Ventilation and Pressure Support Ventilation Groups.	Mean values of respiratory rate between 5 and 45 minutes compared between spontaneous ventilation and pressure support ventilation groups.	Up to 45 minutes
Mean Values of Respiratory Rate Compared Between the Spontaneous Ventilation and Pressure Control Ventilation Groups.	Mean values of respiratory rate between 5 and 45 minutes compared between the spontaneous ventilation and pressure control ventilation groups.	Up to 45 minutes
Mean Values of Respiratory Rate Compared Between Pressure Support Ventilation and Pressure Control Ventilation Groups.	Mean values of respiratory rate between 5 and 45 minutes compared between pressure support ventilation and pressure control ventilation groups.	Up to 45 minutes

Collaborators and Investigators

• Sponsor: Wake Forest University
• Investigators: Principal Investigator: Thomas Templeton, M.D., Wake Forest

Publications and helpful links

General Publications

• Brain AI, McGhee TD, McAteer EJ, Thomas A, Abu-Saad MA, Bushman JA. The laryngeal mask airway. Development and preliminary trials of a new type of airway. Anaesthesia. 1985 Apr;40(4):356-61.

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: February 8, 2013
• First Submitted That Met QC Criteria: July 31, 2017
• First Posted (Actual): August 1, 2017

Study Record Updates

• Last Update Posted (Actual): March 18, 2022
• Last Update Submitted That Met QC Criteria: March 9, 2022
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: general anesthesia; infants; ventilation; outpatient surgery; Proseal™ LMA
• Other Study ID Numbers: IRB00011814

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes