AMBU AScope2 Fiberoptic Intubation Versus Fastrach Intubating LMA

This study has been completed.
Sponsor:
Collaborator:
AMBU
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: March 22, 2016
Last verified: March 2016
  Purpose
The purpose of this study is to compare two types of supraglottic airways (SGA), the Ambu® Aura-I and the Intubating Laryngeal Mask Airway (ILMA), 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
Supraglottic 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: Duration of Intubation, including supraglottic airway (SGA) insertion and endotracheal tube (ETT) insertion ] [ Designated as safety issue: No ]
    Total Intubation Time includes time for SGA insertion and for ETT insertion. The total time to intubation was measured from the beginning of SGA insertion to successful endotracheal tube intubation verified by detection of CO2 on the capnogram.


Secondary Outcome Measures:
  • Time for Supraglottic Airway (SGA) Insertion [ Time Frame: At SGA insertion ] [ Designated as safety issue: No ]
    Time for SGA insertion was measured from when the tip of the cuff was at the mouth to detection of CO2 on the capnogram.

  • Time for Endotracheal Tube (ETT) Insertion [ Time Frame: At ETT insertion ] [ Designated as safety issue: No ]
    After the SGA is inserted, time for intubation will be recorded. Time for ETT insertion was measured, for arm 1, from when the AMBU aScope is at the connector level of the Aura-I or, for arm 2, from when the ETT is at the connector level of the Intubating LMA to first detection of CO2 on the capnogram. 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.

  • Number of Participants in Whom SGA Insertion Was Successful on the First Attempt [ Time Frame: At SGA insertion ] [ Designated as safety issue: No ]
  • Number of Participants in Whom ETT Insertion Was Successful on the First Attempt [ Time Frame: At ETT insertion ] [ Designated as safety issue: No ]
  • Subjective Ease of SGA Insertion as Assessed by a 5-point Scale [ Time Frame: At SGA insertion ] [ Designated as safety issue: No ]
    Ease of SGA insertion is subjectively assessed by the operator on a scale from 1 to 5 (1 = extremely easy, 5 = extremely difficult).

  • Subjective Ease of ETT Insertion as Assessed by a 5-point Scale [ Time Frame: At ETT insertion ] [ Designated as safety issue: No ]
    Ease of ETT insertion is subjectively assessed by the operator on a scale from 1 to 5 (1 = extremely easy, 5 = extremely difficult).

  • Post-Operative Discomfort Upon Entering the Post-Anesthesia Care Unit (PACU) [ Time Frame: Within 30 minutes of completion of surgery ] [ 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.

  • Post-Operative Discomfort Upon Leaving the Post-Anesthesia Care Unit (PACU) [ Time Frame: Approximately 1-2 hours after entering the PACU ] [ 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.


Other Outcome Measures:
  • Orolaryngeal Pressure [ Time Frame: Following SGA Insertion ] [ Designated as safety issue: No ]
    The oropharyngeal leak pressure (OLP) was determined by closing the expiratory valve of the circle system at a fixed gas flow of 3 L/min and noting the airway pressure at which equilibrium was reached (not permitted to exceed 40 cm H2O).


Enrollment: 66
Study Start Date: July 2010
Study Completion Date: January 2013
Primary Completion Date: January 2013 (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   (Adult, Senior)
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

Locations
United States, Texas
Memorial Hermann Hospital - Texas Medical Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
AMBU
Investigators
Principal Investigator: Carin A Hagberg, MD The University of Texas Medical School at Houston
  More Information

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
Results First Received: March 22, 2016
Last Updated: March 22, 2016
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 August 28, 2016