N/A
N=75
GlideScope Video Laryngoscope Versus Fiberoptic Intubation
Oral Intubation
Bottom Line
View on ClinicalTrials.gov: NCT01091948 ↗Enrolled (actual)
75
Serious AEs
0.0%
Results posted
Dec 2016
Primary outcome: Primary: Time to Intubation (TTI) as Measured in Seconds — 43; 37 seconds — p=0.19
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Intubation with Fiberoptic laryngoscope (Device); GlideScope® Video Laryngoscope (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Cleveland Clinic
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Intubation (TTI) as Measured in Seconds |
43; 37 | 0.19 |
| SECONDARY Intubation Difficulty Score |
20; 15 | 0.58 |
| SECONDARY Successful Intubation on 1st Attempt |
31; 36 | 0.15 |
| SECONDARY Occurrence of Hypoxaemia |
2; 4 | 0.57 |
| SECONDARY Trace Bleeding |
1; 1 | 0.79 |
| SECONDARY Sore Throat Grade |
19; 21; 14; 11; 2; 3 | 0.82 |
| SECONDARY Number of Intubation Attempts |
31; 36; 3; 1; 2; 0 | — |
Summary
Following informed consent, patients will be randomly assigned to oral fiberoptic intubation or to oral intubation using the GlideScope Video Laryngoscope. Following the induction of general anesthesia a sealed envelope would be opened to reveal the technique to be used. A stop watch will be started at the beginning of the procedure. At the completion of intubation the stop watch will be stopped and the time recorded along with other data. Based on a sample size estimation process, it is the investigators plan to study fifty patients. The two techniques will be compared in terms of the average time needed to place the endotracheal tube and studied using a two-sided T-Test with a significance level of 0.05. To ensure comparability between the two methods, all intubators will be required to have at experienced at least 10 uses of the GlideScope and 10 uses with fiberoptic intubation.
Eligibility Criteria
Inclusion Criteria
- at least 18 years old
- scheduled for elective surgery requiring orotracheal intubation.
Exclusion Criteria
- known, difficult airway
- loose teeth
- pregnant
- require a rapid sequence induction,
- Body Mass Index under 30
- unable to give consent
- if special endotracheal tube (ETT) is needed for the case.
Data sourced from ClinicalTrials.gov (NCT01091948). 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.