Comparison of Two Novel Indirect Laryngoscopes to the Macintosh Laryngoscope in Patients With Cervical Spine Immobilization.
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|ClinicalTrials.gov Identifier: NCT01032460|
Recruitment Status : Completed
First Posted : December 15, 2009
Last Update Posted : November 9, 2010
It is essential that anaesthetists successfully perform orotracheal intubation in scenarios in which intubation is potentially more difficult, such as where the neck is immobilized.
The Airtraq® Laryngoscope and the CMAC are new intubating devices. They are designed to provide a view of the glottis without alignment of the oral, pharyngeal and tracheal axes.
These devices may be especially effective in situations where intubation of the trachea is potentially difficult.
The efficacy of these devices in comparison to the traditional Macintosh laryngoscope in situations where the cervical spine is immobilized is not known.
The investigators aim to compare the performances of the Airtraq® Laryngoscope and the CMAC to that of the Macintosh laryngoscope, the gold standard device, in patients in which the cervical spine has been immobilized by means of a Manual in-line stabilization of the spine.
Hypothesis: The primary hypothesis is that, in the hands of experienced anaesthetists, time to intubation would be shorter using the indirect laryngoscopes, than using the Macintosh laryngoscope in simulated difficult laryngoscopy.
|Condition or disease||Intervention/treatment||Phase|
|Immobilization||Device: intubate with the macintosh laryngoscope Device: intubate with the C-MAC laryngoscope Device: intubate with the Airtraq device||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||November 2010|
|Actual Study Completion Date :||November 2010|
|Active Comparator: macintosh||
Device: intubate with the macintosh laryngoscope
intubate with the macintosh laryngoscope
|Active Comparator: C-MAC||
Device: intubate with the C-MAC laryngoscope
intubate with the C-MAC laryngoscope
|Active Comparator: Airtraq||
Device: intubate with the Airtraq device
intubate with the Airtraq device
- Rate of successful placement of Tube in the Trachea a. Failed intubation defined as requiring greater than 60s or which resulted in Oesophageal Intubation. b. Successful intubation confirmed by an investigator. [ Time Frame: immediately ]
- Duration of Intubation attempt (successful Attempts only) a. Absolute time taken to perform successful tracheal intubation b. Number of successful intubations completed within 30 seconds. [ Time Frame: immediatley ]
- Tracheal Intubation attempts. a. Overall number of attempts at Intubation. b. Number of successful intubations on first attempt [ Time Frame: immediately ]
- Laryngeal View Obtained a. Cormac and Lehane Grading of Best Laryngeal View b. POGO score [ Time Frame: immediately ]
- Intubation Difficulty Scale score [ Time Frame: immediately ]
- Need for and number of optimisation Manoeuvres to aid tracheal intubation [ Time Frame: immediately ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01032460
|Galway University Hospital|