Comparison of ProSeal Laryngeal Mask Airway to Laryngeal Mask Airway Supreme

This study is currently recruiting participants.

Verified May 2012 by Penn State University

Sponsor:

Information provided by (Responsible Party):

Sonia Vaida, Penn State University

ClinicalTrials.gov Identifier:

NCT00836095

First received: February 2, 2009

Last updated: January 31, 2013

Last verified: May 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

February 2, 2009

Last Updated Date

January 31, 2013

Start Date ^ICMJE

January 2009

Estimated Primary Completion Date

January 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Primary variable outcomes are: insertion time and insertion success rate [ Time Frame: December 2009 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00836095 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

oxygenation, ventilation ,malposition frequency, fiberoptic view (of the final anatomic position), oropharyngeal leak pressure, ventilatory parameters, ease of gastric tube insertion and need for interventions to achieve an effective airway. [ Time Frame: December 2009 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Comparison of ProSeal Laryngeal Mask Airway to Laryngeal Mask Airway Supreme

Official Title ^ICMJE

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

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 The laryngeal mask airway Supreme is a newer version of the laryngeal mask airway.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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research

Condition ^ICMJE

Adverse Effect of Unspecified General Anesthetics

Intervention ^ICMJE

Device: Supreme Laryngeal mask airway
Supreme Laryngeal mask airway is a new, single use laryngeal mask airway variant
Device: Proseal laryngeal mask airway
Proseal is a multiple use, variant of the laryngeal mask airway

Study Arm (s)

Supreme LMA
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. Both airway devices will be blindly inserted by an experienced attending anesthesiologist.
Interventions:
- Device: Supreme Laryngeal mask airway
- Device: Proseal laryngeal mask airway
Active Comparator: Proseal LMA
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. Both airway devices will be blindly inserted by an experienced attending anesthesiologist.
Interventions:
- Device: Supreme Laryngeal mask airway
- Device: Proseal laryngeal mask airway

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

130

Estimated Completion Date

December 2013

Estimated Primary Completion Date

January 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Sonia J Vaida, M.D.

717-531-0000 ext 8434

svaida@psu.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00836095

Other Study ID Numbers ^ICMJE

IRB 29920

Has Data Monitoring Committee

Yes

Responsible Party

Sonia Vaida, Penn State University

Study Sponsor ^ICMJE

Penn State University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Sonia J Vaida, MD

Penn State

Information Provided By

Penn State University

Verification Date

May 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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