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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00966433
First Posted: August 27, 2009
Last Update Posted: November 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Wake Forest University Health Sciences
  Purpose
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.

Condition Intervention
Intraoperative Ventilation Procedure: Spontaneous ventilation Procedure: Pressure support Ventilation Procedure: Pressure control ventilation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Comparison of Different Ventilation Strategies in Children Using the Proseal™ Laryngeal Mask Airway

Further study details as provided by Wake Forest University Health Sciences:

Primary Outcome Measures:
  • Differences in end-tidal carbon dioxide and tidal volume compared between the spontaneous ventilation and pressure support ventilation groups. [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Differences in respiratory rates between spontaneous ventilation and pressure support ventilation groups. [ Time Frame: 6 months ]
  • Mean values of respiratory rate compared between the spontaneous ventilation and pressure control ventilation groups. [ Time Frame: 6 months ]
  • Mean values of respiratory rate compared between pressure support ventilation and pressure control ventilation groups. [ Time Frame: 6 months ]

Enrollment: 33
Study Start Date: August 2009
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Spontaneous ventilation
Pt's will be allowed to breathe spontaneously through the PLMA during surgery without the assistance of positive pressure ventilation.
Procedure: Spontaneous ventilation
The patient will breathe spontaneously (on their own)while under general anesthesia throughout the duration of the surgery.
Experimental: Pressure support ventilation
Pt's will receive positive pressure assistance with each spontaneous breath through the PLMA.
Procedure: 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
Pt.'s will be placed on the ventilator and ventilated with pressure control. through the PLMA.
Procedure: 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.

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™ 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00966433


Locations
United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
Principal Investigator: Thomas W Templeton, M.D. Wake Forest University Health Sciences
  More Information

Publications:

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT00966433     History of Changes
Other Study ID Numbers: PLMA study WFU
First Submitted: August 25, 2009
First Posted: August 27, 2009
Last Update Posted: November 6, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Wake Forest University Health Sciences:
Proseal™ LMA
children
ventilation
general anesthesia
Children under general anesthesia for outpatient surgery

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs