N/A
N=140
Video-laryngoscope With a Novel Video-stylet for Difficult Intubation
Difficult Endotracheal Intubation
Bottom Line
View on ClinicalTrials.gov: NCT01215695 ↗Enrolled (actual)
140
Serious AEs
2.9%
Results posted
Jul 2017
Primary outcome: Primary: Intubation Time — 66; 71 time in seconds — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- aScope (Ambu Inc. 6740 Baymeadow Drive Glen Burnie, MD) (Device); Control (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Louisville
- Primary completion
- Oct 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intubation Time |
66; 71 | <0.05 sig |
| SECONDARY The Number of Intubation Attempts |
1.2; 1.1 | <0.05 sig |
| SECONDARY Neck Movement |
47; 54 | 0.05 |
| SECONDARY Laryngeal View Grade of 1 or 2 |
62; 50 | 0.05 |
| SECONDARY Ease of Intubation |
36; 39 | 0.05 |
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).
Eligibility Criteria
Inclusion Criteria
- BMI > 35
- Thyromental distance 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
Data sourced from ClinicalTrials.gov (NCT01215695). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.