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Completed

NCT Number: NCT01409785

A Comparison of the LMA Unique and LMA Supreme in Children

The goal of this study is to compare the LMA Unique and LMA Supreme in children having surgery. We hypothesize that the airway leak pressures with the LMA Supreme will be superior to the LMA Unique. Airway leak pressures will be measured by recording the circuit pressure at which equilibrium is reached. The ease of placement, fiberoptic grade of laryngeal view, feasibility of use, and complications (airway related, gastric insufflation, trauma) will also be assessed.

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Key information

Conditions

Children

Age range

6 month–6 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Childrens Memorial Hospital

Chicago, Illinois, 60614, United States

About this study

The LMA Supreme is a newer version of the current model, the laryngeal mask airway Unique. Both models are approved for use by the FDA, and are routinely used for airway management during general anesthesia. Three main features distinguish the laryngeal mask airway Supreme from the original LMA: i) a curved rigid airway tube, ii) provision for a gastric drain tube, and iii) a larger mask for improved fit and airway seal.

The aim of this randomized prospective study is to compare two types of the laryngeal mask airway: the laryngeal mask airway Unique and the laryngeal mask airway Supreme, in pediatric patients without the use of neuromuscular blockade. Based on the design features listed above, we hypothesize that the airway leak pressures with the LMA Supreme will be superior to the LMA Unique. Airway leak pressures will be measured by recording the circuit pressure at which equilibrium is reached. The ease of placement, fiberoptic grade of laryngeal view, feasibility of use, and complications (airway related, gastric insufflation, trauma) will also be assessed.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Children undergoing general anesthesia using a supraglottic airway device
  • weight 10-25kg
  • age 6 months-6 years

Exclusion criteria

ASA class IV, V Emergency procedures

  • History of a difficult airway
  • Active gastrointestinal reflux
  • Active upper respiratory tract infection

Treatment and study plan

Primary outcomes

  1. Airway leak pressure

    Time frame: after placement of the supraglottic airway device/ Participants will be followed 24 hours postoperatively

    Airway leak pressures will be measured by recording the circuit pressure at which equilibrium is reached when fresh gas flow is delivered at 3L/min when the pressure limiting valve is closed completely.

Secondary outcomes

  1. Fiberoptic grade of laryngeal view

    Time frame: After placement of the supraglottic device

    The laryngeal alignment through the devices will be graded using an established scoring system

  2. Adverse effects

    Time frame: Participants will be followed 24 hours postoperatively

    complications such as oxygen desaturations, mucosal trauma, reflex activation of the airway, sore throat, dysphonia will be recorded

  3. Time to secure the airway

    Time frame: after placement of the supraglottic airway device

    From picking up the airway device to bilateral chest expansion and presence of ETCO2

  4. Number of attempts to place the device

    Time frame: at the beginning of anesthesia

    number of attempts needed for successful placement will be recorde (maximum of 3 attempts will be considered as a failure)

  5. Fiberoptic view through the gastric tube

    Time frame: After placement of the LMA supreme

    The view through the gastric drain tube of the LMA supreme will be assessed and graded using an established scoring system

  6. Ease of gastric tube placement

    Time frame: After placement of the LMA supreme

    The ease of gastric placement will be assessed using a subjective scale

  7. Gastric insufflation

    Time frame: During leak pressure testing

    The presence of gastric insufflations will be assessed during leak pressure testing by using epigastric auscultation

  8. Quality of the airway

    Time frame: During maintenance of anesthesia

    The quality of hands free anesthesia will be assessed during maintenance of anesthesia using a previously described scale

Sponsors and collaborators

Lead sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Other

Registry information

Official study title

A Prospective, Randomized Comparison of the LMA Unique and LMA Supreme in Children

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Aug 4, 2011
Registry last updated
Oct 5, 2011

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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