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OpenTrials
Completed

NCT Number: NCT00836095

Comparison of ProSeal Laryngeal Mask Airway to Laryngeal Mask Airway Supreme

Laryngeal mask airway is a widely used device in routine anesthesia for airway management during surgery. It consists of a tube with an inflatable cuff that is inserted into the mouth after induction of general anesthesia. The Proseal Laryngeal mask airway and the Laryngeal mask airway Supreme are two variants of the Laryngeal mask airway. The laryngeal mask airway Supreme is a newer version of the laryngeal mask airway.

The research is being done to compare two variants of the laryngeal mask airway: the Proseal laryngeal mask airway and the Laryngeal mask airway Supreme. This study will determine if the newer model, the Laryngeal mask airway Supreme, is easier to insert and is better positioned than the older model, the Proseal laryngeal mask airway. Both models are approved for use by the FDA, and are routinely used to assure the airway during general anesthesia.

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Key information

Conditions

Adverse Effect of Unspecified General Anesthetics

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

PennState Hershey Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18 - 75 years
  • ASA I and II
  • Mallampatti class: I and II
  • Thyromental distance > than 6.5 cm
  • Interincisor distance > than 3 cm
  • BMI < 35 Kg/m2
  • Patients scheduled to undergo anesthesia with an LMA for minor extraperitoneal surgical procedures in supine position

Exclusion criteria

  • Weight < 50 kg
  • BMI > 35 Kg/m2
  • Pregnant patients
  • Known or expected difficult airway
  • Patients with active, untreated and unresolved gastroesophageal reflux
  • Esophageal pathology, pulmonary pathology
  • Laparoscopic procedures
  • ENT procedures, gastrointestinal procedures, intraperitoneal surgical procedure

Treatment and study plan

Supreme Laryngeal Mask Airway

Device

Supreme Laryngeal mask airway is a new, single use laryngeal mask airway variant

ProSeal Laryngeal mask airway

Device

Proseal is a multiple use, variant of the laryngeal mask airway

Primary outcomes

  1. Insertion Time

    Time frame: During intubation of the patient

    The insertion time will be the measured time that it takes the anesthesiologist to insert the airway and verify ventilation of the patient's airway. Data reported will be time in seconds ± the standard deviation.

Secondary outcomes

  1. Insertion Success Rate

    Time frame: During intubation of the patient

    Insertion success rate will be reported as the number of patients for whom the airway device was successfully inserted and ventilation was verified.

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Registry information

Official study title

A Randomized Controlled Trial Comparing the ProSeal Laryngeal Mask Airway With the Laryngeal Mask Airway Supreme in Mechanically Ventilated Patients

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Feb 4, 2009
Registry last updated
Apr 15, 2016

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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