CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 52 enrolled
Drug / intervention
Supreme Laryngeal mask airway +1 moredevice
Likely dose
Not stated in record
Key inclusion· 7
  • Age 18–75 years
  • ASA Class I or II (good health or mild systemic disease)
  • Favorable airway anatomy: Mallampati Class I or II
  • Thyromental distance >6.5 cm
Key exclusion· 8
  • Weight <50 kg
  • BMI ≥35 kg/m²
  • Pregnant patients
  • Known or expected difficult airway

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00836095
NCT00836095Phase 4Completed

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

Milton S. Hershey Medical Center·interventional·Posted Feb 4, 2009·Updated Apr 15, 2016

In Brief

A Phase 4 clinical trial evaluating Supreme Laryngeal mask airway and Proseal laryngeal mask airway for Adverse Effect of Unspecified General Anesthetics. Completed, enrolled 52 participants across 1 site.

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 The laryngeal mask airway Supreme is a newer version of the laryngeal mask airway.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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 4, 2009
Enrollment StartJan 1, 2009
Primary CompletionJan 1, 2013
Study CompletionApr 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 17.4 years ago

Interventions

Supreme Laryngeal mask airwaydevice

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

Proseal laryngeal mask airwaydevice

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