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NCT01215695 · ClinicalTrials.gov registry record · NA
Video-laryngoscope With a Novel Video-stylet for Difficult Intubation
A NA study of Difficult Endotracheal Intubation, sponsored by University of Louisville.
- Completed
- Registry status
- NA
- Development phase
- 140
- Enrollment target
- 1
- Study location
NCT01215695: Completed NA study of Difficult Endotracheal Intubation, sponsored by University of Louisville.
NCT01215695 is a NA study of Difficult Endotracheal Intubation that has completed, run by University of Louisville. The registered enrollment target is 140 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01215695, a NA study of Difficult Endotracheal Intubation, has completed, sponsored by University of Louisville.
- COMPLETED
- Registry status
- NA
- Development phase
- 140 participants
- Enrollment target
- 1
- Study location
Study 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).
Primary Outcome
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 appro
Conditions Studied
Interventions
- DEVICE Control
- DEVICE aScope (Ambu Inc. 6740 Baymeadow Drive Glen Burnie, MD)
Study Locations (1)
Kentucky
- University of Louisville Hospital - Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2010-08 |
| Est. Completion | 2013-12 |
| Phase | NA |
What the finished NCT01215695 record still lists
NCT01215695 is an interventional study that assigns participants to a tested intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Difficult Endotracheal Intubation appearing as the primary indexed condition, and to 2 interventions - of which Control is the first listed.
NCT01215695 reports a single indexed study location in Kentucky.
Frequently Asked Questions
What is clinical trial NCT01215695 about?
NCT01215695 is a clinical study titled "Video-laryngoscope With a Novel Video-stylet for 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 intubat...
What is the current status of trial NCT01215695?
This trial is currently completed. It is a NA study. The enrollment target is 140 participants. The study started on 2010-08. Estimated completion is 2013-12.
What conditions does trial NCT01215695 study?
This clinical trial studies the following conditions: Difficult Endotracheal Intubation.
What interventions are being tested in trial NCT01215695?
The interventions under investigation include: Control (DEVICE), aScope (Ambu Inc. 6740 Baymeadow Drive Glen Burnie, MD) (DEVICE).
Who is sponsoring clinical trial NCT01215695?
This trial is sponsored by University of Louisville, which has 217 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01215695 being conducted?
This trial has 1 study location across Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01215695's enrollment target sits among peer trials
140 713th of 2000 higher than 1,281 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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