AMBU AScope2 Fiberoptic Intubation Versus Fastrach Intubating LMA
Recruitment status was Recruiting
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.
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 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|
- 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.
- 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.
- 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.
|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)|
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|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01656967
|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|
|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|
|Principal Investigator:||Carin A Hagberg, MD||The University of Texas Medical School at Houston|