ClinicalTrials.gov
ClinicalTrials.gov Menu

Video-laryngoscope With a Novel Video-stylet for Difficult Intubation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01215695
Recruitment Status : Completed
First Posted : October 6, 2010
Results First Posted : July 27, 2017
Last Update Posted : September 8, 2017
Sponsor:
Information provided by (Responsible Party):
Rainer Lenhardt, University of Louisville

July 22, 2010
October 6, 2010
April 9, 2017
July 27, 2017
September 8, 2017
August 2010
October 2013   (Final data collection date for primary outcome measure)
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.
Intubation Time [ Time Frame: During intubation ]
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.
Complete list of historical versions of study NCT01215695 on ClinicalTrials.gov Archive Site
  • 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.
  • 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
  • laryngeal view grade [ Time Frame: 30 minutes ]
    The laryngeal view grade according to the method described by Cormack and Lehane
  • 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.
Not Provided
Not Provided
 
Video-laryngoscope With a Novel Video-stylet for Difficult Intubation
Feasibility of a Combined Use of a Video-laryngoscope With a Novel Video-stylet for Predicted Difficult Intubation
We propose to enroll 140 subjects scheduled for elective or urgent/emergent surgery with general anesthesia including endotracheal intubation. Patients qualify for the trial if they are considered a difficult airway case as determined by measurement of common predictive indices for difficult intubation (see inclusion criteria). All patients will be intubated with a GVL. Patients will be randomly assigned to either having their ETT placed with use of a pre-formed stylet provided by the manufacturer of the GVL (control group) or with a flexible, disposable tracheoscope (aScope, Ambu, Denmark) (intervention group). The randomization will be stratified as to whether patients are categorized as predicted difficult airway or have an immobilized cervical spine (C-collar in place).
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Difficult Endotracheal Intubation
  • 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
  • Device: Control
    pre-formed stylet provided by the manufacturer of the GlideScope® video laryngoscope
  • 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)
    Intervention: Device: Control
  • Experimental: Intervention
    Patients will be randomly assigned to either having their ETT placed with use of flexible, disposable tracheoscope (aScope, Ambu, Denmark) (intervention group).
    Intervention: Device: aScope (Ambu Inc. 6740 Baymeadow Drive Glen Burnie, MD)
Lenhardt R, Burkhart MT, Brock GN, Kanchi-Kandadai S, Sharma R, Akça O. Is video laryngoscope-assisted flexible tracheoscope intubation feasible for patients with predicted difficult airway? A prospective, randomized clinical trial. Anesth Analg. 2014 Jun;118(6):1259-65. doi: 10.1213/ANE.0000000000000220. Erratum in: Anesth Analg. 2015 Feb;120(2):495.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
140
Same as current
December 2013
October 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • BMI > 35
  • Thyromental distance < 6 cm
  • Sterno-mental distance < 12 cm
  • Mallampati grade 3 and 4
  • Interincisor distance < 38 mm
  • Status of dentition: presence of buckteeth
  • Neck movement < 35°
  • Neck circumference >43 cm at the level of the thyroid cartilage
  • Patients with immobilized cervical spine (C-collar in place).
  • History of difficult laryngoscopy or intubation

Exclusion Criteria:

  • Full stomach
  • Hiatal hernia
  • Severe GERD (Gastroesophageal reflux disease)
  • Tumors of the upper airway
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01215695
UofL IRB #10.0300
No
Not Provided
Not Provided
Rainer Lenhardt, University of Louisville
University of Louisville
Not Provided
Principal Investigator: Rainer Lenhardt, MD University of Louisville
University of Louisville
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP