NCT00966433

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

August 25, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 27, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
9.1 years until next milestone

Results Posted

Study results publicly available

November 13, 2018

Completed
Last Updated

December 5, 2018

Status Verified

November 1, 2018

Enrollment Period

2 months

First QC Date

August 25, 2009

Results QC Date

August 21, 2018

Last Update Submit

November 9, 2018

Conditions

Intraoperative Ventilation

Keywords

Proseal™ LMAchildrenventilationgeneral anesthesiaChildren under general anesthesia for outpatient surgery

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (3)

  • Differences in Respiratory Rates Between Spontaneous Ventilation and Pressure Support Ventilation Groups.

    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

Study Arms (3)

Spontaneous ventilation

EXPERIMENTAL

Pt's will be allowed to breathe spontaneously through the PLMA during surgery without the assistance of positive pressure ventilation.

Procedure: Spontaneous ventilation

Pressure support ventilation

EXPERIMENTAL

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

Device: Pressure support Ventilation

Pressure control ventilation

ACTIVE COMPARATOR

Pt.'s will be placed on the ventilator and ventilated with pressure control. through the PLMA.

Device: Pressure control ventilation

Interventions

Spontaneous ventilationPROCEDURE

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

Spontaneous ventilation
Pressure support VentilationDEVICE

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 support ventilation
Pressure control ventilationDEVICE

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

Pressure control ventilation

Eligibility Criteria

Age12 Months - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (12)

  • 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.

    PMID: 4003736BACKGROUND

  • 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.

    PMID: 2100990BACKGROUND

  • 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.

    PMID: 15298876BACKGROUND

  • 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.

    PMID: 18166745BACKGROUND

  • 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.

    PMID: 12060328BACKGROUND

  • 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.

    PMID: 18647269BACKGROUND

  • 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.

    PMID: 16490094BACKGROUND

  • 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.

    PMID: 15920181BACKGROUND

  • 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.

    PMID: 8984875BACKGROUND

  • 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.

    PMID: 11696145BACKGROUND

  • 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.

    PMID: 10597550BACKGROUND

  • 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.

    PMID: 18042854BACKGROUND

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Thomas Templeton, MD
Organization
Wake Forest University Health Sciences
ttemplet@wakehealth.edu
336-716-4285

Study Officials

  • Thomas W Templeton, M.D.

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2009

First Posted

August 27, 2009

Study Start

August 1, 2009

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

December 5, 2018

Results First Posted

November 13, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)