NCT02380768

Brief Summary

The purpose of this study is to determine whether there is a clinically relevant difference in airway leak pressures between the Ambu AuraGain and the Laryngeal Mask Airway (LMA) Supreme.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2015

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

First Submitted

Initial submission to the registry

February 26, 2015

Completed
3 days until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 5, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

July 20, 2015

Status Verified

July 1, 2015

Enrollment Period

3 months

First QC Date

February 26, 2015

Last Update Submit

July 17, 2015

Conditions

Supraglottic Airway

Keywords

Supraglottic airwayLaryngeal mask airwayChildren

Outcome Measures

Primary Outcomes (2)

  • Oropharyngeal (airway) leak pressure - Initial

    The airway pressure at which an airway leak is observed after successful placement of the supraglottic airway

    Assessed intraoperatively at the time of confirmed device placement

  • Oropharyngeal (airway) leak pressure - 10 Minutes

    The airway pressure at which an airway leak is observed 10 minutes after successful placement of the supraglottic airway

    Assessed intraoperatively, 10 minutes after the initial confirmed placement of the device

Secondary Outcomes (8)

  • Time for Successful Placement of the Supraglottic Airway

    Assessed intraoperatively at the time of confirmed device placement

  • Number of attempts to placement of Supraglottic Airway

    Assessed intraoperatively at the time of confirmed device placement

  • Fiberoptic Grade of Laryngeal View through Supraglottic Airway

    Assessed intraoperatively at the time of confirmed device placement

  • Gastric Tube Insertion Ease of Placement

    Assessed intraoperatively at the time of confirmed gastric tube placement

  • Gastric Tube Insertion Time

    Assessed intraoperatively at the time of confirmed gastric tube placement

  • +3 more secondary outcomes

Study Arms (2)

Ambu AuraGain

EXPERIMENTAL

Subjects will receive the Ambu AuraGain size 1.5 or 2.0 based on manufacturer guidelines

Device: Ambu AuraGain (size 1.5 or size 2.0)

LMA Supreme

ACTIVE COMPARATOR

Subjects will receive the Ambu AuraGain size 1.5 or 2.0 based on manufacturer guidelines

Device: LMA Supreme (size 1.5 or size 2.0)

Interventions

Ambu AuraGain (size 1.5 or size 2.0)DEVICE

The device will be inserted and timed. A leak pressure test will be performed after successful insertion and after 10 minutes. The larynx will be visualized by placing a fiberoptic bronchoscope through the device. A gastric tube will be inserted through the device and timed.

Also known as: Ambu AuraGain
Ambu AuraGain
LMA Supreme (size 1.5 or size 2.0)DEVICE

The device will be inserted and timed. A leak pressure test will be performed after successful insertion and after 10 minutes. The larynx will be visualized by placing a fiberoptic bronchoscope through the device. A gastric tube will be inserted through the device and timed.

Also known as: LMA Supreme
LMA Supreme

Eligibility Criteria

Age3 Months - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Scheduled for surgery utilizing a supraglottic airway device
  • ASA (American Society of Anesthesiologists) I-III classification
  • Weighing between 5 - 20 kilograms

You may not qualify if:

  • Active respiratory infection
  • History of difficult mask ventilation
  • Diagnosis of congenital syndrome with difficult airway management
  • Active gastrointestinal reflux
  • Coagulopathy
  • Significant Pulmonary disease
  • Emergent surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ann & Robert H Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

Related Publications (4)

  • White MC, Cook TM, Stoddart PA. A critique of elective pediatric supraglottic airway devices. Paediatr Anaesth. 2009 Jul;19 Suppl 1:55-65. doi: 10.1111/j.1460-9592.2009.02997.x.

    PMID: 19572845BACKGROUND

  • Jagannathan N, Ramsey MA, White MC, Sohn L. An update on newer pediatric supraglottic airways with recommendations for clinical use. Paediatr Anaesth. 2015 Apr;25(4):334-45. doi: 10.1111/pan.12614. Epub 2015 Jan 13.

    PMID: 25585975BACKGROUND

  • Jagannathan N, Sohn LE, Sawardekar A, Gordon J, Langen KE, Anderson K. A randomised comparison of the LMA SupremeTM and LMAProSealTM in children. Anaesthesia. 2012 Jun;67(6):632-9. doi: 10.1111/j.1365-2044.2012.07088.x. Epub 2012 Mar 15.

    PMID: 22420717BACKGROUND

  • Jagannathan N, Sohn L, Sommers K, Belvis D, Shah RD, Sawardekar A, Eidem J, Dagraca J, Mukherji I. A randomized comparison of the laryngeal mask airway supreme and laryngeal mask airway unique in infants and children: does cuff pressure influence leak pressure? Paediatr Anaesth. 2013 Oct;23(10):927-33. doi: 10.1111/pan.12145. Epub 2013 Mar 23.

    PMID: 23521105BACKGROUND

Study Officials

  • Narasimhan Jagannathan, M.D.

    Ann & Robert H Lurie Children's Hospital of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary Investigator; M.D.

Study Record Dates

First Submitted

February 26, 2015

First Posted

March 5, 2015

Study Start

March 1, 2015

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

July 20, 2015

Record last verified: 2015-07

Locations

US(1)