AMBU AScope2 Fiberoptic Intubation Versus Fastrach Intubating LMA

This study is currently recruiting participants.
Verified July 2012 by The University of Texas Health Science Center, Houston
Sponsor:
Collaborator:
AMBU A/S (Ballerup, Denmark)
Information provided by (Responsible Party):
Carin A. Hagberg, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT01656967
First received: July 30, 2012
Last updated: August 2, 2012
Last verified: July 2012
  Purpose

The purpose of this study is to compare the Ambu® Aura-I to the Intubating Laryngeal Mask Airway (LMA) regarding time to intubate, ease of insertion, sealing properties, optical view upon fiberoptic examination regarding the Ambu Aura-I, ease and success rate of intubation, airway morbidity, and patient comfort in patients undergoing general anesthesia for elective surgery.


Condition Intervention
Laryngeal Mask Airways as a Conduit for Intubation
Device: AMBU Aura-I LMA and aScope 2 Disposable Fiberoptic Camera
Device: LMA Fastrach Single Use

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Flexible Optical Intubation Via the AMBU Aura-I Versus Blind Intubation Via the Fastrach Single Use Intubating LMA - A Prospective Randomized Clinical Trial

Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • Total Intubation Time [ Time Frame: The Duration of Intubation. Calculated by addition of LMA insertion time and ETT insertion time (Approximately 40 - 250 seconds) ] [ Designated as safety issue: No ]
    Total Intubation Time includes time for LMA insertion and Tube Insertion.


Secondary Outcome Measures:
  • Time for LMA Insertion [ Time Frame: LMA Insertion from the time the LMA cuff is placed at the patient's lips until the a CO2 tracing is observed (Approximately 20-100 seconds) ] [ Designated as safety issue: No ]
    Time required to insert LMA. The AMBU Aura-I LMA will be used in Group 1, whereas the Fastrach Single Use Intubating LMA will be used for Group 2 patients. Time will be recorded from when the LMA is at the patient's lips to when a CO2 trace is recorded.

  • Intubation Time [ Time Frame: Duration of Tube Insertion, From the time the Tube is at the patient's lips until a CO2 tracing is recorded (Approximately 40-250 seconds) ] [ Designated as safety issue: No ]
    After the LMA is inserted, time for intubation will be recorded. The AScope 2 disposable fiberoptic camera will be used to assist with intubation for Group 1 patients. Group 2 patients will be intubated using the LMA-Fastrach EndoTracheal Tube.

  • Intubation Success Rate [ Time Frame: Duration of Intubation (Approximately 3 minutes) ] [ Designated as safety issue: No ]
    Number of attempts required for successful intubation will be recorded.

  • Subjective Ease of Intubation [ Time Frame: Duration of Intubation (Approximately 3 minutes) ] [ Designated as safety issue: No ]
    Subjective Difficulty of intubation will be recorded by the intubationist on a 5 point scale: 1- Very Easy 2- Easy 3- Slight Resistance 4- Difficult 5- Not Possible. Separate scores will be recorded for LMA Insertion, Tube Insertion, and aScope Insertion (Group 1 patients).

  • Post-Operative Discomfort [ Time Frame: Duration of stay in Post-Anesthesia Care Unit (Approximately 1-2 hours) ] [ Designated as safety issue: No ]
    The patient will be assessed for Post-Operative Hoarseness, Sore Mouth, Sore Neck, Sore Jaw, Dysphonia, Dysphagia and Altered Tongue Sensation on entrance to Post-Anesthesia Care United (PACU) and on exit from PACU.


Other Outcome Measures:
  • LMA Cuff Sealing Properties [ Time Frame: Following LMA Insertion (Approximately 3-5 minutes) ] [ Designated as safety issue: No ]
    Following LMA Insertion, the LMA cuff pressure will be calibrated using a manometer until it is 60-70 cm H2O. Leak pressure will then be assessed.


Estimated Enrollment: 66
Study Start Date: July 2010
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AMBU Aura-I/aScope 2
First, the AMBU Aura-I LMA will be inserted. Then, then patient will be intubated with assistance of the AMBU aScope 2 disposable fiberoptic system.
Device: AMBU Aura-I LMA and aScope 2 Disposable Fiberoptic Camera
Experimental: LMA Fastrach
The LMA Fastrach Single Use Laryngeal Mask Airway (The Laryngeal Mask Airway Company, California) will be placed, followed by blind intubation using the LMA Fastrach EndoTracheal Tube.
Device: LMA Fastrach Single Use

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult surgical Candidates Aged 18-80 years
  • ASA I-III
  • Mallampati Score of I or II
  • BMI ≤ 35 kg/m2
  • Presenting for elective surgery
  • Require General Endotracheal Anesthesia.

Exclusion Criteria:

  • Previously known difficult airway,
  • Emergency status
  • Require prone positioning
  • Interincisor distance < 2.5cm
  • Thyromental distance < 5cm
  • Clinically suspected difficult airway
  • Contraindications to LMA Insertion, such as Reflux disease
  • Patients who do not require endotracheal intubation
  • Indications for Rapid Sequence Induction (RSI)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01656967

Contacts
Contact: Carin A Hagberg, MD (713) 500-6200 Carin.A.Hagberg@uth.tmc.edu
Contact: Alfonso V Altamirano, MD (713) 500-6304 Alfonso.V.Altamirano@uth.tmc.edu

Locations
United States, Texas
Memorial Hermann Hospital - Texas Medical Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Carin A Hagberg, MD         
Sub-Investigator: Carlos Artime, MD         
Sub-Investigator: Katherine Normand, MD         
Sub-Investigator: Lara Ferrario, MD         
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
AMBU A/S (Ballerup, Denmark)
Investigators
Principal Investigator: Carin A Hagberg, MD The University of Texas Medical School at Houston
  More Information

No publications provided

Responsible Party: Carin A. Hagberg, Professor and Chair, Department of Anesthesiology, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01656967     History of Changes
Other Study ID Numbers: HSC-MS-10-0604
Study First Received: July 30, 2012
Last Updated: August 2, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center, Houston:
Laryngeal Mask Airway
LMA
Intubation
AMBU
AScope
Aura-I
Fastrach
Fiberoptic
Disposable Fiberoptic
Blind Intubation
Fiberoptic Intubation

ClinicalTrials.gov processed this record on April 16, 2014