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.

Study Overview

• Status: Completed
• Conditions: Intraoperative Ventilation
• Intervention / Treatment: Device: Pressure control ventilation; Procedure: Spontaneous ventilation; Device: Pressure support 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™ 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.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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; 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.	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; Pt.'s will be placed on the ventilator and ventilated with pressure control. through the PLMA.	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
Differences in End-tidal Carbon Dioxide Compared Between the Spontaneous Ventilation and Pressure Support Ventilation Groups.	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	up to 90 minutes
Differences Tidal Volume Compared Between the Spontaneous Ventilation and Pressure Support Ventilation Groups.	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	up to 90 minutes
Mean Values of ETCO2 in SV and PCV Groups	Mean Values of ETCO2 in SV and PCV groups reported in mmHg	up to 90 minutes
Mean Tidal Volume Values Compared Between SV and PCV Groups	Mean Tidal Volume Values compared between SV and PCV Groups. Measured in mL/kg	up to 90 minutes
Mean Values of ETCO2 Between the PSV and PCV Groups	Mean Values of ETCO2 between the PSV and PCV Groups. Measured in mmHg	up to 90 minutes
Mean Values of Tidal Volume Between the PSV and PCV Groups	Mean Values of Tidal Volume Between the PSV and PCV Groups. Measured in mL/kg	up to 90 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences in Respiratory Rates Between Spontaneous Ventilation and Pressure Support Ventilation Groups.	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.	up to 90 minutes
Mean Values of Respiratory Rate Compared Between the Spontaneous Ventilation and Pressure Control Ventilation Groups.		up to 90 minutes
Mean Values of Respiratory Rate Compared Between Pressure Support Ventilation and Pressure Control Ventilation Groups.		up to 90 minutes

Collaborators and Investigators

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

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.
• Lopez-Gil M, Brimacombe J, Alvarez M. Safety and efficacy of the laryngeal mask airway. A prospective survey of 1400 children. Anaesthesia. 1996 Oct;51(10):969-72. doi: 10.1111/j.1365-2044.1996.tb14968.x.
• Mason DG, Bingham RM. The laryngeal mask airway in children. Anaesthesia. 1990 Sep;45(9):760-3. doi: 10.1111/j.1365-2044.1990.tb14449.x.
• Shimbori H, Ono K, Miwa T, Morimura N, Noguchi M, Hiroki K. Comparison of the LMA-ProSeal and LMA-Classic in children. Br J Anaesth. 2004 Oct;93(4):528-31. doi: 10.1093/bja/aeh238. Epub 2004 Aug 6.
• Lardner DR, Cox RG, Ewen A, Dickinson D. Comparison of laryngeal mask airway (LMA)- Proseal and the LMA-Classic in ventilated children receiving neuromuscular blockade. Can J Anaesth. 2008 Jan;55(1):29-35. doi: 10.1007/BF03017594. Erratum In: Can J Anaesth. 2008 May;55(5):321.
• Bagshaw O. The size 1.5 laryngeal mask airway (LMA) in paediatric anaesthetic practice. Paediatr Anaesth. 2002 Jun;12(5):420-3. doi: 10.1046/j.1460-9592.2002.00887.x.
• Licina A, Chambers NA, Hullett B, Erb TO, von Ungern-Sternberg BS. Lower cuff pressures improve the seal of pediatric laryngeal mask airways. Paediatr Anaesth. 2008 Oct;18(10):952-6. doi: 10.1111/j.1460-9592.2008.02706.x. Epub 2008 Jul 21.
• Wheeler M. ProSeal laryngeal mask airway in 120 pediatric surgical patients: a prospective evaluation of characteristics and performance. Paediatr Anaesth. 2006 Mar;16(3):297-301. doi: 10.1111/j.1460-9592.2005.01788.x.
• Goldmann K, Jakob C. A randomized crossover comparison of the size 2 1/2 laryngeal mask airway ProSeal versus laryngeal mask airway-Classic in pediatric patients. Anesth Analg. 2005 Jun;100(6):1605-1610. doi: 10.1213/01.ANE.0000152640.25078.90.
• Keidan I, Berkenstadt H, Segal E, Perel A. Pressure versus volume-controlled ventilation with a laryngeal mask airway in paediatric patients. Paediatr Anaesth. 2001 Nov;11(6):691-4. doi: 10.1046/j.1460-9592.2001.00746.x.
• Lopez Gil ML, Brimacombe J, Clar B. Sevoflurane versus propofol for induction and maintenance of anaesthesia with the laryngeal mask airway in children. Paediatr Anaesth. 1999;9(6):485-90. doi: 10.1046/j.1460-9592.1999.00404.x.
• Garcia-Fernandez J, Tusman G, Suarez-Sipmann F, Llorens J, Soro M, Belda JF. Programming pressure support ventilation in pediatric patients in ambulatory surgery with a laryngeal mask airway. Anesth Analg. 2007 Dec;105(6):1585-91, table of contents. doi: 10.1213/01.ane.0000287674.64086.f1.

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): October 1, 2009
• Study Completion (Actual): October 1, 2009

Study Registration Dates

• First Submitted: August 25, 2009
• First Submitted That Met QC Criteria: August 26, 2009
• First Posted (Estimate): August 27, 2009

Study Record Updates

• Last Update Posted (Actual): December 5, 2018
• Last Update Submitted That Met QC Criteria: November 9, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: children; general anesthesia; ventilation; Proseal™ LMA; Children under general anesthesia for outpatient surgery
• Other Study ID Numbers: IRB00009452

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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