Comparison of ProSeal Laryngeal Mask Airway to Laryngeal Mask Airway Supreme

NCT00836095 | Completed Phase 4 Results DMC

• 1 other identifier: IRB 29920
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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 The laryngeal mask airway Supreme is a newer version of the laryngeal mask airway.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.

Conditions

Adverse Effect of Unspecified General Anesthetics

Keywords

laryngeal mask, proseal

Outcome Measures

Primary Outcomes (1)

• Insertion Time

  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.

  During intubation of the patient

Secondary Outcomes (1)

• Insertion Success Rate

  During intubation of the patient

Study Arms (2)

Supreme LMA

OTHER

Supreme Laryngeal mask airway is a new, single use laryngeal mask airway variant. The choice of the airway device will be randomized by opening a sealed envelope immediately before induction. The airway device will be blindly inserted by an experienced attending anesthesiologist.

Device: Supreme Laryngeal mask airway

Proseal LMA

ACTIVE COMPARATOR

Proseal is a multiple use, variant of the laryngeal mask airway. The choice of the airway device will be randomized by opening a sealed envelope immediately before induction. The airway device will be blindly inserted by an experienced attending anesthesiologist.

Device: Proseal laryngeal mask airway

Interventions

Supreme Laryngeal mask airway DEVICE

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

Supreme LMA

Proseal laryngeal mask airway DEVICE

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

Proseal LMA

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

PennState Hershey Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Results Point of Contact

• Title: Sonia Vaida MD, Professor of Anesthesiology
• Organization: Penn State Milton S. Hershey Medical Center

svaida@hmc.psu.edu

7175318433

Study Officials

• Sonia J Vaida, MD

  Penn State

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D, Vice Chair for Research

Study Record Dates

• First Submitted: February 2, 2009
• First Posted: February 4, 2009
• Study Start: January 1, 2009
• Primary Completion: January 1, 2013
• Study Completion: April 1, 2013
• Last Updated: April 15, 2016
• Results First Posted: June 3, 2014

Record last verified: 2016-03

Locations

US (1)