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NCT Number: NCT01449656

A Comparison of the Laryngeal Mask Airway (LMA) Proseal and LMA Supreme in Children

The aim of this randomized prospective study is to compare two laryngeal mask airways with a provision for evacuation of gastric contents, the LMA Proseal and The investigators hypothesize that airway leak pressures with the LMA Proseal will be significantly different (higher) when compared with the LMA Supreme.

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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 goal of this study is to compare the LMA Proseal and LMA Supreme in children having surgery. The investigators hypothesize that the airway leak pressures with the LMA Proseal will be superior to the LMA Supreme. Airway leak pressures will be measured by recording the circuit pressure at which equilibrium is reached. The ease of placement of the device and gastric tube, fiberoptic grade of laryngeal view, feasibility of use during positive pressure ventilation, 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 10-20 kg
  • 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

LMA Proseal: control device

Device

LMA Proseal will be placed in children weighing 10-20kg based on a computer generated randomization

Other names: laryngeal mask airway

LMA Supreme: comparison device

Device

LMA Supreme will be placed in children weighing 10-20kg based on a computer generated randomization

Other names: laryngeal mask airway

Primary outcomes

  1. Airway Leak Pressure

    Time frame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours

    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. Time to secure the airway

    Time frame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours

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

  2. Number of attempts to place the device

    Time frame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours

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

  3. Fiberoptic grade of laryngeal view

    Time frame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours

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

  4. Gastric insufflation

    Time frame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours

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

  5. Ease of gastric tube placement

    Time frame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours

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

  6. Fiberoptic view through the gastric tube

    Time frame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours

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

  7. feasibility of positive pressure ventilation

    Time frame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours

    Peak inspiratory pressure and tidal volumes will be recorded. Maximum peak inspiratory pressure will be the airway leak pressure was determined for each patient

  8. Quality of the airway

    Time frame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours

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

  9. Adverse effects

    Time frame: Participants will be followed for the duration of anesthesia and 24 hours postoperatively

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

Sponsors and collaborators

Lead sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Other

Registry information

Official study title

A Randomized Trial Comparing the Laryngeal Mask Airway-SupremeTM With the Laryngeal Mask Airway-ProsealTM in Children

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Oct 10, 2011
Registry last updated
Dec 12, 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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