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CompletedNCT00966433Updated Dec 5, 2018Results posted

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

An interventional study of Spontaneous ventilation and Pressure support Ventilation in Intraoperative Ventilation, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 12 Months to 5 Years. Per ClinicalTrials.gov, last updated 2018-12-05.

Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
33
Allocation
Randomized
Ages
12 Months to 5 Years
Sex
All
01

Study 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 children under general anesthesia.

Read the 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.

02

Conditions studied

  • Intraoperative Ventilation

Keywords

  • Proseal™ LMA
  • children
  • ventilation
  • general anesthesia
  • Children under general anesthesia for outpatient surgery
03

In context

Lead sponsor

Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.

Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Months to 5 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
33 participants (actual)

Study arms

  • 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

  • Experimental
    Pressure support ventilation

    Pt's will receive positive pressure assistance with each spontaneous breath through the PLMA.

    Device: Pressure support Ventilation

  • 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

Interventions

  • ProcedureSpontaneous ventilation

    The patient will breathe spontaneously (on their own)while under general anesthesia throughout the duration of the surgery.

  • DevicePressure 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.

  • DevicePressure control ventilation

    The patient's ventilation will be completely supported by the anesthesia machine while under general anesthesia throughout the duration of the surgery.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: up to 90 minutes

  2. 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

    Time frame: up to 90 minutes

  3. Mean Values of ETCO2 in SV and PCV Groups

    Mean Values of ETCO2 in SV and PCV groups reported in mmHg

    Time frame: up to 90 minutes

  4. Mean Tidal Volume Values Compared Between SV and PCV Groups

    Mean Tidal Volume Values compared between SV and PCV Groups. Measured in mL/kg

    Time frame: up to 90 minutes

  5. Mean Values of ETCO2 Between the PSV and PCV Groups

    Mean Values of ETCO2 between the PSV and PCV Groups. Measured in mmHg

    Time frame: up to 90 minutes

  6. 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

    Time frame: up to 90 minutes

Secondary outcomes

  1. 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.

    Time frame: up to 90 minutes

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

    Time frame: up to 90 minutes

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

    Time frame: up to 90 minutes

07

Results

Posted Nov 13, 2018

Participant flow

Participant flow — Overall Study
MilestoneSpontaneous VentilationPressure Support VentilationPressure Control Ventilation
Started111111
Completed101011
Not completed110

Outcome measures

PrimaryDifferences 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

Time frame:
up to 90 minutes
Reported as:
Mean · mmHg
Differences in End-tidal Carbon Dioxide Compared Between the Spontaneous Ventilation and Pressure Support Ventilation Groups.
mmHgSpontaneous VentilationPressure Support Ventilation
Differences in End-tidal Carbon Dioxide Compared Between the Spontaneous Ventilation and Pressure Support Ventilation Groups.55.2 ± 5.547 ± 6
Statistical analysis
  • Spontaneous Ventilation vs Pressure Support Ventilation · t-test, 2 sided · p = .0051 · Mean difference (final values): -8.2 · 95% CI -13.61 to -2.79
PrimaryDifferences 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

Time frame:
up to 90 minutes
Reported as:
Mean · mL/kg
Differences Tidal Volume Compared Between the Spontaneous Ventilation and Pressure Support Ventilation Groups.
mL/kgSpontaneous VentilationPressure Support Ventilation
Differences Tidal Volume Compared Between the Spontaneous Ventilation and Pressure Support Ventilation Groups.4.0 ± .87.6 ± .5
Statistical analysis
  • Spontaneous Ventilation vs Pressure Support Ventilation · t-test, 2 sided · p = .0001 · Mean difference (final values): 3.6 · 95% CI 2.97 to 4.23
PrimaryMean Values of ETCO2 in SV and PCV Groups

Mean Values of ETCO2 in SV and PCV groups reported in mmHg

Time frame:
up to 90 minutes
Reported as:
Mean · mmHg
Mean Values of ETCO2 in SV and PCV Groups
mmHgSpontaneous VentilationPressure Control Ventilation
Mean Values of ETCO2 in SV and PCV Groups55.2 ± 5.543.1 ± 0.8
PrimaryMean Tidal Volume Values Compared Between SV and PCV Groups

Mean Tidal Volume Values compared between SV and PCV Groups. Measured in mL/kg

Time frame:
up to 90 minutes
Reported as:
Mean · mL/kg
Mean Tidal Volume Values Compared Between SV and PCV Groups
mL/kgSpontaneous VentilationPressure Control Ventilation
Mean Tidal Volume Values Compared Between SV and PCV Groups4.0 ± 0.87.6 ± 0.2
PrimaryMean Values of ETCO2 Between the PSV and PCV Groups

Mean Values of ETCO2 between the PSV and PCV Groups. Measured in mmHg

Time frame:
up to 90 minutes
Reported as:
Mean · mmHg
Mean Values of ETCO2 Between the PSV and PCV Groups
mmHgPressure Support VentilationPressure Control Ventilation
Mean Values of ETCO2 Between the PSV and PCV Groups47.0 ± 6.043.1 ± 0.8
PrimaryMean 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

Time frame:
up to 90 minutes
Reported as:
Mean · mL/kg
Mean Values of Tidal Volume Between the PSV and PCV Groups
mL/kgPressure Support VentilationPressure Control Ventilation
Mean Values of Tidal Volume Between the PSV and PCV Groups7.6 ± 0.57.6 ± 0.2
SecondaryDifferences 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.

Time frame:
up to 90 minutes
Reported as:
Mean · breath/min
Differences in Respiratory Rates Between Spontaneous Ventilation and Pressure Support Ventilation Groups.
breath/minSpontaneous VentilationPressure Support Ventilation
Differences in Respiratory Rates Between Spontaneous Ventilation and Pressure Support Ventilation Groups.28.1 ± 5.314.2 ± 5.3
Statistical analysis
  • Spontaneous Ventilation vs Pressure Support Ventilation · t-test, 2 sided · p = .0001 · Mean difference (final values): -13.9 · 95% CI -18.88 to -8.92
SecondaryMean Values of Respiratory Rate Compared Between the Spontaneous Ventilation and Pressure Control Ventilation Groups.
Time frame:
up to 90 minutes
Reported as:
Mean · breath/min
Mean Values of Respiratory Rate Compared Between the Spontaneous Ventilation and Pressure Control Ventilation Groups.
breath/minSpontaneous VentilationPressure Control Ventilation
Mean Values of Respiratory Rate Compared Between the Spontaneous Ventilation and Pressure Control Ventilation Groups.28.1 ± 5.321.2 ± 3.0
SecondaryMean Values of Respiratory Rate Compared Between Pressure Support Ventilation and Pressure Control Ventilation Groups.
Time frame:
up to 90 minutes
Reported as:
Mean · breath/min
Mean Values of Respiratory Rate Compared Between Pressure Support Ventilation and Pressure Control Ventilation Groups.
breath/minPressure Support VentilationPressure Control Ventilation
Mean Values of Respiratory Rate Compared Between Pressure Support Ventilation and Pressure Control Ventilation Groups.14.2 ± 5.321.2 ± 3.0

Adverse events

Collected over up to 90 minutes. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Spontaneous Ventilation0/10 (0%)0/10 (0%)0/10 (0%)
Pressure Support Ventilation0/10 (0%)0/10 (0%)0/10 (0%)
Pressure Control Ventilation0/11 (0%)0/11 (0%)0/11 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(Months)Spontaneous VentilationPressure Support VentilationPressure Control VentilationTotal
Mean28 ± 1832 ± 1727 ± 1628.9 ± 17.01
Sex: Female, Male
Sex: Female, Male(Participants)Spontaneous VentilationPressure Support VentilationPressure Control VentilationTotal
Female1113
Male991028
ASA Status
ASA Status(Participants)Spontaneous VentilationPressure Support VentilationPressure Control VentilationTotal
I98926
II1225
08

Study locations

1 site
  • Wake Forest University Health Sciences
    Winston-Salem, North Carolina 27157, United States
09

References and documents

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. PubMed 4003736 ↗
  • 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. PubMed 2100990 ↗
  • 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. PubMed 15298876 ↗
  • 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. PubMed 18166745 ↗
  • 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. PubMed 12060328 ↗
  • 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. PubMed 18647269 ↗
  • 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. PubMed 16490094 ↗
  • 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. PubMed 15920181 ↗
  • 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. PubMed 8984875 ↗
  • 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. PubMed 11696145 ↗
  • 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. PubMed 10597550 ↗
  • 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. PubMed 18042854 ↗

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00966433
Lead sponsor
Wake Forest University Health Sciences
Responsible party
Sponsor
First posted
Aug 27, 2009
Start date
Aug 2009
Primary completion
Oct 2009
Completion
Oct 2009
Results posted
Nov 13, 2018
Last update
Dec 5, 2018

Study contacts

Thomas W Templeton, M.D.
principal investigator · Wake Forest University Health Sciences

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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