AMBU AScope2 Fiberoptic Intubation Versus Fastrach Intubating LMA

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by The University of Texas Health Science Center, Houston.
Recruitment status was  Recruiting
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014