Clinical Trials Directory

Trials / Completed

CompletedNCT01215695

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
140 (actual)
Sponsor
University of Louisville · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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).

Conditions

Interventions

TypeNameDescription
DEVICEaScope (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.
DEVICEControlpre-formed stylet provided by the manufacturer of the GlideScope® video laryngoscope

Timeline

Start date
2010-08-01
Primary completion
2013-10-01
Completion
2013-12-01
First posted
2010-10-06
Last updated
2017-09-08
Results posted
2017-07-27

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01215695. Inclusion in this directory is not an endorsement.