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

Ventilation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03235817
• Other study ID #: IRB00011814
• Status: Completed
• Phase: N/A
• Start date: December 2009
• Est. completion date: July 2010

Study information

• Verified date: April 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 11 Months

Eligibility

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.

Related Conditions & MeSH terms

• Ventilation

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Wake Forest Baptist Health	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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