Comparison of the Video and Macintosh Laryngoscope in Patients Who May be Difficult to Intubate
|First Received Date ICMJE||September 12, 2005|
|Last Updated Date||May 11, 2007|
|Start Date ICMJE||August 2003|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||5 scale score of glottic view; Time and number of attempts required; Level of difficulty; Degree of irritation of the pharynx, epiglottis, and aryteniods|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00178555 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||Vital signs, oxygen saturation, and end-tidal carbon dioxide|
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Comparison of the Video and Macintosh Laryngoscope in Patients Who May be Difficult to Intubate|
|Official Title ICMJE||A Comparison of Laryngoscopy Techniques Using the Video Laryngoscope and the Traditional Macintosh Laryngoscope in Patients Who May be Difficult to Intubate|
The purpose of this study is to determine if the Video Laryngoscope (VL) is a useful instrument in patients at risk for difficult intubation. We will compare this device to the traditional Macintosh Laryngoscope.
Despite improvements made to the traditional laryngoscope blade since its invention, occasionally intubation of the trachea cannot be accomplished with facility, even in patients with anatomy that does not predict difficult intubation. It is estimated that endotracheal intubation is performed on some 8 million patients per year in the United States. Of these endotracheal intubations, approximately 80% are performed by direct laryngoscopy with transoral placement of the endotracheal tube (ET) into the trachea. There is fairly uniform reporting of the incidence of failed intubation in the literature; it occurs in approximately 0.05% or 1:2230 of surgical patients and in approximately 0.13% to 0.35%, or 1:750 to 1:280, of the obstetric patients. The incidence of unsuspected difficult intubation is estimated to be higher at 3%. One factor that contributes to difficult intubation is poor visualization.
The VL is designed to optimize visualization by presenting to the operator an enlarged video image of airway structures. In contrast, using conventional laryngoscopy, anesthesiologists have only a “keyhole” view of the airway structures; a view that may be further obscured during attempts to pass the ET.
The VL consists of a laryngoscope handle and Macintosh blade that have been modified to provide a video image of airway structures on a screen, which can be conveniently located directly in front of the anesthesiologist. A micro video module is contained in the modified handle. An image/light bundle is introduced into the standard blade. This system has been previously tested in which the consensus was that the device is extremely easy to learn to use because most anesthesiologists are familiar with the use of the Macintosh blade. It has also been useful in the instruction of laryngoscopy by non-anesthesiologists.
There are several potential advantages of a video image in the context of direct laryngoscopy. The system provides high quality video images that are enlarged on the video monitor for easier visualization. If laryngeal manipulation is required to improve visualization of laryngeal structures, the intubator and the person assisting can coordinate movements as they observe, simultaneously, the image on the video monitor. With the video image projected from the distal end of the laryngoscope blade, laryngeal structures are kept in view as the ET is passed through the oropharynx into the trachea.
Comparison: Video Laryngoscope as a conduit for possible difficult intubation compared to the traditional Macintosh blade.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 4|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
|Condition ICMJE||Intubation, Endotracheal|
|Study Arm (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||February 2007|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years to 80 Years|
|Accepts Healthy Volunteers||Not Provided|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00178555|
|Other Study ID Numbers ICMJE||HSC-MS-03-082|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||The University of Texas Health Science Center, Houston|
|Collaborators ICMJE||KARL STORZ ENDOSCOPY-AMERICA, Inc.|
|Information Provided By||The University of Texas Health Science Center, Houston|
|Verification Date||May 2007|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP