GlideScope Video Laryngoscope vs Fiberoptic Intubation
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All trials for Oral Intubation All trials of Intubation with Fiberoptic laryngoscope All trials of GlideScope® Video Laryngoscope
-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.
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+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Fiberoptic Intubation | Active comparator | Device: Intubation with Fiberoptic laryngoscope | Subjects will be intubated with the Fiberoptic laryngoscope. |
| GlideScope® Video Laryngoscope | Active comparator | Device: GlideScope® Video Laryngoscope | Subjects will be intubated with the GlideScope® Video Laryngoscope. |
- Intubation with Fiberoptic laryngoscope (Device), also known as Fiberoptic, laryngoscope: Subjects will be intubated with the Fiberoptic laryngoscope.
- GlideScope® Video Laryngoscope (Device), also known as GlideScope®, Video Laryngoscope: Patients will be intubated with the GlideScope® Video Laryngoscope.
+Outcome measures
Primary outcomes
- Time to Intubation (TTI) as Measured in Seconds [from start of intubation to successfully intubated up to 100 seconds]: Time from insertion of either the GlideScope or in the case of fibreoptic intubation, a Williams airway (SunMed, Largo, FL, USA) into the mouth, to the time when end-tidal PCO2 exceeded 2.7 kPa (20 mmHg).
Secondary outcomes
- Intubation Difficulty Score [from start of intubation to successfully intubated]: Intubation difficulty score is a 100-mm-long visual analogue scale (100 mm = extremely difficult);
- Successful Intubation on 1st Attempt [from start of first intubation to end of first intubation attempt]
- Occurrence of Hypoxaemia [at 1 min prior to intubation, intubation, and 2, 4, 6, 8, and 10 min after]: Arterial oxygen saturation was recorded at 1 min prior to intubation, intubation, and 2, 4, 6, 8, and 10 min after; hypoxaemia was defined as occurrence of arterial oxygen saturation <90% at any of the above measurements.
- Trace Bleeding [Right after intubation]: Trace bleeding is a binary outcome: yes or no, which is determined based on amount of post-intubation bleeding present in the suction tube
- Sore Throat Grade [On the first postoperative day]
- Number of Intubation Attempts [from start of intubation to successfully intubated]
+Eligibility
Sex: All, ages: 18 Years to any
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.
+Posted results
Participant flow
| Milestone | Active Comparator: Fiberoptic Intubation | GlideScope® Video Laryngoscope |
|---|
| Started | 37 | 38 |
| Completed | 37 | 38 |
| Not completed | 0 | 0 |
Outcome results
- Time to Intubation (TTI) as Measured in Seconds (Primary), Median, seconds: Active Comparator: Fiberoptic Intubation 43 (35 to 58); GlideScope® Video Laryngoscope 37 (25 to 48) (p 0.19)
- Intubation Difficulty Score (Secondary), Median, units on a scale: Fiberoptic Intubation 20 (11 to 40); GlideScope® Video Laryngoscope 15 (10 to 21) (p 0.58)
- Successful Intubation on 1st Attempt (Secondary), Number, participants: Fiberoptic Intubation 31; GlideScope® Video Laryngoscope 36 (p 0.15)
- Occurrence of Hypoxaemia (Secondary), Number, participants: Fiberoptic Intubation 2; GlideScope® Video Laryngoscope 4 (p 0.57)
- Trace Bleeding (Secondary), Number, participants: Fiberoptic Intubation 1; GlideScope® Video Laryngoscope 1 (p 0.79)
- Sore Throat Grade (Secondary), Number, participants: Fiberoptic Intubation 19; GlideScope® Video Laryngoscope 21 (p 0.82)
- Number of Intubation Attempts (Secondary), Number, participants: Fiberoptic Intubation 31; GlideScope® Video Laryngoscope 36
Adverse events
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|
| Fiberoptic | 0 | 0/37 (0.0%) | 0/37 (0.0%) |
| GlideScope® Video Laryngoscope | 0 | 0/38 (0.0%) | 0/38 (0.0%) |
+Locations (1)
| Facility | City | Country | Status |
|---|
| Cleveland Clinic Foundation | Cleveland, Ohio | United States | |
+Investigators