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

University of Louisville (UOFL)

Status: Completed

Conditions: Difficult Endotracheal Intubation

Treatments: Device: Control; Device: aScope (Ambu Inc. 6740 Baymeadow Drive Glen Burnie, MD)

Study type: Interventional

Funder types: Other

Identifiers

NCT01215695

UofL IRB #10.0300

Details and patient eligibility

About

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).

Enrollment: 140 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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140 participants in 2 patient groups

Control

Active Comparator group

Description:

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)

Treatment:

Device: Control

Intervention

Experimental group

Description:

Patients will be randomly assigned to either having their ETT placed with use of flexible, disposable tracheoscope (aScope, Ambu, Denmark) (intervention group).

Treatment:

Device: aScope (Ambu Inc. 6740 Baymeadow Drive Glen Burnie, MD)