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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fiberoptic Intubation | Active Comparator | Subjects will be intubated with the Fiberoptic laryngoscope. |
|
| GlideScope® Video Laryngoscope | Active Comparator | Subjects will be intubated with the GlideScope® Video Laryngoscope. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intubation with Fiberoptic laryngoscope | Device | Subjects will be intubated with the Fiberoptic laryngoscope. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Intubation (TTI) as Measured in 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). | from start of intubation to successfully intubated up to 100 seconds |
| Measure | Description | Time Frame |
|---|---|---|
| Intubation Difficulty Score | Intubation difficulty score is a 100-mm-long visual analogue scale (100 mm = extremely difficult); | from start of intubation to successfully intubated |
| Successful Intubation on 1st Attempt |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel I Sessler, MD | The Cleveland Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Comparator: Fiberoptic Intubation | Subjects will be intubated with the Fiberoptic laryngoscope. Active Comparator: GlideScope® Video Laryngoscope Subjects will be intubated with the GlideScope® Video Laryngoscope |
| FG001 | GlideScope® Video Laryngoscope | Subjects will be intubated with the GlideScope® Video Laryngoscope. GlideScope® Video Laryngoscope: Patients will be intubated with the GlideScope® Video Laryngoscope. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fiberoptic Intubation | Subjects will be intubated with the Fiberoptic laryngoscope. Intubation with Fiberoptic laryngoscope: Subjects will be intubated with the Fiberoptic laryngoscope. |
| BG001 | GlideScope® Video Laryngoscope |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Intubation (TTI) as Measured in 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). | Posted | Median | Inter-Quartile Range | seconds | from start of intubation to successfully intubated up to 100 seconds |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fiberoptic | Subjects will be intubated with the Fiberoptic laryngoscope. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Basem Abdelmalak | Cleveland Clinic Foundation | 216-444-3746 | abdelmb@ccf.org |
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| ID | Term |
|---|---|
| D007440 | Intubation |
| D055100 | Optical Fibers |
| D020704 | Laryngoscopes |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
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| GlideScope® Video Laryngoscope | Device | Patients will be intubated with the GlideScope® Video Laryngoscope. |
|
|
| from start of first intubation to end of first intubation attempt |
| Occurrence of Hypoxaemia | 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. | at 1 min prior to intubation, intubation, and 2, 4, 6, 8, and 10 min after |
| Trace Bleeding | Trace bleeding is a binary outcome: yes or no, which is determined based on amount of post-intubation bleeding present in the suction tube | Right after intubation |
| Sore Throat Grade | On the first postoperative day |
| Number of Intubation Attempts | from start of intubation to successfully intubated |
Subjects will be intubated with the GlideScope® Video Laryngoscope.
GlideScope® Video Laryngoscope: Patients will be intubated with the GlideScope® Video Laryngoscope.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Gender | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Median | Inter-Quartile Range | Kg |
|
| Height | Mean | Standard Deviation | cm |
|
| Body mass index | Median | Inter-Quartile Range | kg/m^2 |
|
| ASA physical status | Number | participants |
|
| Modified Mallampati classification | Modified Mallampati classification was not collected for one patient in the GlideScope Video Laryngoscope group. | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Intubation Difficulty Score | Intubation difficulty score is a 100-mm-long visual analogue scale (100 mm = extremely difficult); | Posted | Median | Inter-Quartile Range | units on a scale | from start of intubation to successfully intubated |
|
|
|
|
| Secondary | Successful Intubation on 1st Attempt | Posted | Number | participants | from start of first intubation to end of first intubation attempt |
|
|
|
|
| Secondary | Occurrence of Hypoxaemia | 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. | Posted | Number | participants | at 1 min prior to intubation, intubation, and 2, 4, 6, 8, and 10 min after |
|
|
|
|
| Secondary | Trace Bleeding | Trace bleeding is a binary outcome: yes or no, which is determined based on amount of post-intubation bleeding present in the suction tube | Posted | Number | participants | Right after intubation |
|
|
|
|
| Secondary | Sore Throat Grade | This outcome was not collected for 1 patient in each group. | Posted | Number | participants | On the first postoperative day |
|
|
|
|
| Secondary | Number of Intubation Attempts | Posted | Number | participants | from start of intubation to successfully intubated |
|
|
|
| 0 |
| 37 |
| 0 |
| 37 |
| EG001 | GlideScope® Video Laryngoscope | Subjects will be intubated with the GlideScope® Video Laryngoscope | 0 | 38 | 0 | 38 |
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| D019723 |
| Endoscopes |
| D019719 | Diagnostic Equipment |
| D013523 | Surgical Equipment |
| Moderate |
|
| Severe |
|
| 3 |
|
| 4 |
|