Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00178555
Status:
COMPLETED
Last Update Posted:
2016-03-23
First Post:
2005-09-12
Brief Title:
Comparison of the Video and Macintosh Laryngoscope in Patients Who May be Difficult to Intubate
Sponsor:
The University of Texas Health Science Center Houston
Organization:
The University of Texas Health Science Center Houston
Study Overview
Official Title:
A Comparison of Laryngoscopy Techniques Using the Video Laryngoscope and the Traditional Macintosh Laryngoscope in Patients Who May be Difficult to Intubate
Status:
COMPLETED
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 005 or 12230 of surgical patients and in approximately 013 to 035 or 1750 to 1280 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 imagelight 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
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 imagelight 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None