Phase 4
N=94
Effectiveness and Safety of the Levitan Scope for Laryngoscopy and Tracheal Intubation With a Simulated Difficult Airway
Airway Complication of Anaesthesia
Bottom Line
View on ClinicalTrials.gov: NCT01491984 ↗Enrolled (actual)
94
Serious AEs
0.0%
Results posted
Mar 2015
Primary outcome: Primary: Cormack-Lehane Grade — 58; 53; 33; 41 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Laryngoscopy order: 1) MAC, 2) Levitan (Device); Laryngoscopy order: 1) Levitan, 2) MAC (Device)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- Female
- Sponsor
- IWK Health Centre
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cormack-Lehane Grade |
58; 53; 33; 41 | — |
| SECONDARY Number of Intubation Attempts |
— | — |
| SECONDARY Operator Rating of Difficulty |
— | — |
| SECONDARY Time to Successful Intubation |
— | — |
Summary
A laryngoscope is a medical instrument that is used to get a view of the voice box and the space in between the vocal cords. A laryngoscope is used to place a breathing tube into the trachea (windpipe or airway) to protect the patient's airway and provide a way to help a person breathe during surgery; this is called intubation.
Eligibility Criteria
Inclusion Criteria
- American Society of Anesthesiologists (ASA) physical status I or II (healthy or mild systemic disease, ex. asthma, high blood pressure)
- Elective surgery requiring endotracheal intubation
- English speaking
- Age 16 - 75 years
Exclusion Criteria
- Significant gastroesophageal reflux disease (GERD) that may require alternate induction/intubation techniques
- Prior history of a difficult intubation requiring an awake tracheal intubation
- Clinical predictors of a potentially difficult intubation requiring an awake intubation
- BMI > 45 kg/m2 (Obesity is a common and important risk factor for difficult intubation)
Data sourced from ClinicalTrials.gov (NCT01491984). 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.