Video-laryngoscope With a Novel Video-stylet for Difficult Intubation
|ClinicalTrials.gov Identifier: NCT01215695|
Recruitment Status : Completed
First Posted : October 6, 2010
Results First Posted : July 27, 2017
Last Update Posted : September 8, 2017
|Condition or disease||Intervention/treatment||Phase|
|Difficult Endotracheal Intubation||Device: aScope (Ambu Inc. 6740 Baymeadow Drive Glen Burnie, MD) Device: Control||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Supportive Care|
|Official Title:||Feasibility of a Combined Use of a Video-laryngoscope With a Novel Video-stylet for Predicted Difficult Intubation|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||December 2013|
Active Comparator: Control
Patients will be randomly assigned to having their ETT placed with use of a pre-formed stylet provided by the manufacturer of the GVL (control group)
pre-formed stylet provided by the manufacturer of the GlideScope® video laryngoscope
Patients will be randomly assigned to either having their ETT placed with use of flexible, disposable tracheoscope (aScope, Ambu, Denmark) (intervention group).
Device: aScope (Ambu Inc. 6740 Baymeadow Drive Glen Burnie, MD)
The aScope is a flexible, disposable plastic tracheoscope that incorporates a high-resolution video camera with an LED light at its flexible tip and has attached monitor.
Other Name: video-stylet
- Intubation Time [ Time Frame: 120 seconds ]divided into time to successfully place the glidescope (visualization of the epiglottis), time to successfully insert the videostylet (passing through the cords) and time to verified placement of the ETT (as outlined above). Interim bag and mask time, if needed, will not be included in the intubation time. More than 5 attempts or 120 s are regarded as failure of intubation. If failure to secure the airway occurs with the GVL and videostylet, then conventional difficult intubation protocols approved by the University of Louisville Hospital will be implemented.
- The Number of Intubation Attempts [ Time Frame: 30 minutes ]counted as each approach of the ETT to the glottic entrance.
- Neck Movement [ Time Frame: 30 minutes ]One observer will video-record the entire intubation procedure. At a later time, an otherwise unrelated observer will watch the video-records and grade the neck movement during intubation. Neck movement will be classified as Grade 0: no neck movement, Grade 1: minimal neck movement, or Grade 2: moderate neck movement. Results are reported as total with mild, moderate, or severe neck movement.
- Laryngeal View Grade of 1 or 2 [ Time Frame: 30 minutes ]The laryngeal view as Grade 1 (full view of the glottis) or Grade 2 (glottis partly exposed, anterior commissure not seen) according to the method described by Cormack and Lehane (1984).
- Ease of Intubation [ Time Frame: 2-4 hours after intubation ]After completion of the procedure the intubator will be asked to score the ease of intubation. To do this, he/she will give a score from 0-100 with 0 being the easiest and 100 being the hardest.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01215695
|United States, Kentucky|
|University of Louisville Hospital|
|Louisville, Kentucky, United States, 40202|
|Principal Investigator:||Rainer Lenhardt, MD||University of Louisville|