CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 140 enrolled
Drug / intervention
aScope (Ambu Inc. 6740 Baymeadow Drive Glen Burnie, MD) +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01215695
NCT01215695N/ACompleted

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

University of Louisville·interventional·Posted Oct 6, 2010·Updated Sep 8, 2017

In Brief

A clinical study evaluating aScope (Ambu Inc. 6740 Baymeadow Drive Glen Burnie, MD) and Control for Difficult Endotracheal Intubation. Completed, enrolled 140 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 6, 2010
Enrollment StartAug 1, 2010
Primary CompletionOct 1, 2013
Study CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 15.7 years ago

Interventions

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

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.

Controldevice

pre-formed stylet provided by the manufacturer of the GlideScope® video laryngoscope