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Completed

NCT Number: NCT02380768

A Comparison of the Ambu AuraGain Versus LMA Supreme in Children

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.

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Key information

Conditions

Supraglottic Airway

Age range

3 month–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ann & Robert H Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

About this study

The goal of this prospective randomized study is to compare whether there is a clinically relevant difference in airway leak pressures between the Ambu AuraGain (sizes 1.5 and 2) and the Laryngeal Mask Airway (LMA) Supreme. Parameters of clinical relevance such as insertion success rates, fiberoptic view of the glottic opening, ease and speed of gastric tube placement, airway stability, and peri-operative complications will also be assessed.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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.

Other names: 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.

Other names: LMA Supreme

Primary outcomes

  1. Oropharyngeal (airway) leak pressure - Initial

    Time frame: Assessed intraoperatively at the time of confirmed device placement

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

  2. Oropharyngeal (airway) leak pressure - 10 Minutes

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

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

Secondary outcomes

  1. Time for Successful Placement of the Supraglottic Airway

    Time frame: Assessed intraoperatively at the time of confirmed device placement

    Time for successful placement of supraglottic device will be recorded

  2. Number of attempts to placement of Supraglottic Airway

    Time frame: Assessed intraoperatively at the time of confirmed device placement

    Number of attempts and insertion techniques will be recorded (maximum of 3 attempts)

  3. Fiberoptic Grade of Laryngeal View through Supraglottic Airway

    Time frame: Assessed intraoperatively at the time of confirmed device placement

    Fiberoptic Grade of Laryngeal View through either device will be graded using a previously published grading system

  4. Gastric Tube Insertion Ease of Placement

    Time frame: Assessed intraoperatively at the time of confirmed gastric tube placement

    The ease of placement, based on a 1-4 scale, will be recorded following placement and confirmation of the gastric tube.

  5. Gastric Tube Insertion Time

    Time frame: Assessed intraoperatively at the time of confirmed gastric tube placement

    The elapsed time from beginning insertion of the gastric tube to confirmation, will be recorded. Confirmation of gastric tube placement will be determined by injection of air with auscultation (listening for sounds) over the stomach with a stethoscope.

  6. Gastric Tube Insertion Attempts

    Time frame: Assessed intraoperatively at the time of confirmed gastric tube placement

    Number of insertion attempts of the gastric tube through the SGA will be recorded. Confirmation of gastric tube placement will be determined by injection of air with auscultation (listening for sounds) over the stomach with a stethoscope.

  7. Postoperative Complications

    Time frame: Participants will be followed for the duration of hospital stay. Outcome measure will be assessed postoperatively in recovery unit.

    Patient will be evaluated for sore throat, cough, dysphonia, stridor, or other airway related complications during the post-operative period.

  8. Intraoperative Complications

    Time frame: Assessed intraoperatively

    Complications such as reflex activation of the airway (coughing, breath holding, laryngospasm, bronchospasm), oxygen desaturation will be recorded, if they occur.

Sponsors and collaborators

Lead sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Other

Registry information

Official study title

A Randomized Comparison of the Ambu AuraGain™ and LMA Supreme™ in Infants and Children

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 5, 2015
Registry last updated
Jul 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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