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This study will compare the Macintosh laryngoscope with the Pentax. The Pentax AWS is a novel airway management device that is designed to facilitate laryngoscopy and endotracheal intubation.
100 obese patients (BMI 30 to 50) requiring orotracheal intubation for elective surgery will be randomly allocated to intubation with either a conventional Macintosh laryngoscope or with the Pentax AWS. Our study hypothesis is that use of Pentax AWS will make tracheal intubation easier to perform in the obese surgical patient (BMI 30 to 50), as evidenced by the time to complete the intubation process as well as an "Ease of Use" visual analog score (VAS) measure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Macintosh laryngoscope | Active Comparator | Intubation with a Macintosh laryngoscope |
|
| Pentax AWS | Active Comparator | Intubation with a Pentax AWS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Macintosh laryngoscope | Device | Intubation with Macintosh laryngoscope |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Intubation | time between sufficient muscle relaxant and placement of intubation tube | time between sufficient muscle relaxant and placement of intubation tube, up to 100 seconds |
| Measure | Description | Time Frame |
|---|---|---|
| Ease of Intubation | Ease of intubation was recorded by the operator immediately after intubation on a 100 mm visual analog scale (VAS). The score ranges from 0 to 100. A higher score indicates more difficulty in intubation | From the start of intubation until 24 hours after surgery |
| Successful Intubation on the First 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 |
| John Doyle, MD, PhD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Macintosh | Intubation with a Macintosh laryngoscope Macintosh intubation: Macintosh intubation |
| FG001 | Pentax | intubation with a the Pentax AWS Pentax AWS: Intubation with Pentax AWS |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Macintosh | Intubation with a Macintosh laryngoscope Macintosh intubation: Macintosh intubation |
| BG001 | Pentax | intubation with a the Pentax AWS Pentax AWS: Intubation with Pentax AWS |
| 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 | time between sufficient muscle relaxant and placement of intubation tube | Posted | Median | Inter-Quartile Range | seconds | time between sufficient muscle relaxant and placement of intubation tube, up to 100 seconds |
|
|
From the start of intubation until 24 hours after surgery
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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 | Macintosh | Intubation with a Macintosh laryngoscope Macintosh intubation: Macintosh intubation |
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It focused on obese patients; did not include patients with a history of difficult intubation; protocol did not include use of adjunctive devices; was impossible to blind the operator to the device being used; only the Mallampati score was recorded
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel I Sessler, MD | Cleveland Clinic Foundation | 216-445-8396 | sesslerd@ccf.org |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Pentax AWS |
| Device |
Intubation with Pentax AWS |
|
The count number of successful intubation on the first attempt |
| From the start of intubation until 24 hours after surgery |
| The Number of Patients With Different Number of Intubation Attempts | We summarized the number of patients with one, two or three intubation attempts. | From the start of intubation until 24 hours after surgery |
| The Number of Patients With Bleeding | From the start of intubation until 24 hours after surgery |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ASA status | American Society of Anesthesiology (ASA) physical status classification system | Number | participants |
|
| Mallampati score | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
|
| Secondary | Ease of Intubation | Ease of intubation was recorded by the operator immediately after intubation on a 100 mm visual analog scale (VAS). The score ranges from 0 to 100. A higher score indicates more difficulty in intubation | Posted | Mean | Standard Deviation | units on a scale | From the start of intubation until 24 hours after surgery |
|
|
|
| Secondary | Successful Intubation on the First Attempt | The count number of successful intubation on the first attempt | Posted | Count of Participants | Participants | From the start of intubation until 24 hours after surgery |
|
|
|
| Secondary | The Number of Patients With Different Number of Intubation Attempts | We summarized the number of patients with one, two or three intubation attempts. | Posted | Count of Participants | Participants | From the start of intubation until 24 hours after surgery |
|
|
|
| Secondary | The Number of Patients With Bleeding | Posted | Count of Participants | Participants | From the start of intubation until 24 hours after surgery |
|
|
|
| 0 |
| 49 |
| 0 |
| 49 |
| EG001 | Pentax | intubation with a the Pentax AWS Pentax AWS: Intubation with Pentax AWS | 0 | 50 | 0 | 50 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| three attempts |
|