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Status:

COMPLETED

Ambu® Laryngeal Mask as an Intubation Conduit

Lead Sponsor:

The University of Texas Health Science Center, Houston

Collaborating Sponsors:

Ambu A/S

Conditions:

Intubation, Endotracheal

Eligibility:

All Genders

18-80 years

Phase:

PHASE4

Brief Summary

The purpose of this study is to determine if the Ambu Laryngeal Mask can be used as an intubation conduit for endotracheal intubation.

Detailed Description

The laryngeal mask airway (LMA) is an established supra-glottic device that provides better ventilation than traditional mask ventilation and is less invasive than endotracheal intubation. Being less ...

Eligibility Criteria

Inclusion

  • The patient is ASA 1-3 presenting for an elective surgical procedure
  • The patient is 18-65 years of age
  • The patient weighs \> 50 kg with a BMI \< 30 kg/m2
  • The patient has a Mallampati grade I -III airway
  • The patient is undergoing general anesthesia with controlled ventilation for minor routine surgical procedures
  • The period of anesthesia time is \>30 minutes

Exclusion

  • The patient is an ASA classification 4
  • The patient is \< 18 or \>65 years of age
  • The patient weighs \< 50 kg or has a BMI \> 30 kg/m2
  • The patient has a history of inadequate cervical mobility
  • The patient has a history or signs of difficult airway management
  • The patient has a Mallampati grade IV Class airway
  • The patient has a mouth opening \< 2.5 cm
  • The patient has an oral cavity disease
  • The patient has a cervical malformation
  • The patient had upper respiratory tract symptoms in the previous 10 days
  • The patient is to have surgery performed to the head/neck or thoracoabdominal cavities needing to be paralyzed, or in the lateral/prone position
  • The patient is considered at risk of aspiration (non-fasted, gastroesophageal reflux/disease)

Key Trial Info

Start Date :

December 1 2005

Trial Type :

INTERVENTIONAL

End Date :

April 1 2007

Estimated Enrollment :

160 Patients enrolled

Trial Details

Trial ID

NCT00272194

Start Date

December 1 2005

End Date

April 1 2007

Last Update

March 23 2016

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Memorial Hermann Hospital

Houston, Texas, United States, 77030