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

Study Overview
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Brief Summary
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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).

Official Title
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Feasibility of a Combined Use of a Video-laryngoscope With a Novel Video-stylet for Predicted Difficult Intubation

Conditions
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Difficult Endotracheal Intubation

Intervention / Treatment
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* Device: aScope (Ambu Inc. 6740 Baymeadow Drive Glen Burnie, MD)
* Device: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>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<br>* pre-formed stylet provided by the manufacturer of the GlideScope® video laryngoscope<br>|
| Experimental: Intervention<br>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)<br>* 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.<br>* Other names: video-stylet;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intubation, Endotracheal, Endotracheal Intubation, adverse events