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).

Study Overview

• Status: Completed
• Conditions: Difficult Endotracheal Intubation
• Intervention / Treatment: Device: Control; Device: aScope (Ambu Inc. 6740 Baymeadow Drive Glen Burnie, MD)

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)	Device: Control; pre-formed stylet provided by the manufacturer of the GlideScope® video laryngoscope
Experimental: Intervention; 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 Names: video-stylet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intubation Time	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.	120 seconds

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Number of Intubation Attempts	counted as each approach of the ETT to the glottic entrance.	30 minutes
Neck Movement	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.	30 minutes
Laryngeal View Grade of 1 or 2	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).	30 minutes
Ease of 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.	2-4 hours after intubation

Collaborators and Investigators

• Sponsor: University of Louisville
• Investigators: Principal Investigator: Rainer Lenhardt, MD, University of Louisville

Publications and helpful links

General Publications

• Lenhardt R, Burkhart MT, Brock GN, Kanchi-Kandadai S, Sharma R, Akca 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: July 22, 2010
• First Submitted That Met QC Criteria: October 5, 2010
• First Posted (Estimate): October 6, 2010

Study Record Updates

• Last Update Posted (Actual): September 8, 2017
• Last Update Submitted That Met QC Criteria: August 8, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Intubation, Endotracheal; Endotracheal Intubation, adverse events
• Other Study ID Numbers: UofL IRB #10.0300