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A recent article examined the use of Parker Flex-Tip tubes to standard ETTs for oral fiberoptic intubation and concluded that there was a significant benefit in terms of difficulty encountered when using the Parker Flex-Tip. The Parker Flex-Tip tracheal tube has a flexible, curved, and tapered tip design different from traditional endotracheal tubes. The design allows the tube to lie closely against the fiberoptic scope that is often used to facilitate intubation, resulting in a smaller gap between the ETT and the fiberoptic scope. This may allow the ETT to clear anatomic obstructions more easily. The patients they examined had an average body mass index (BMI) categorized as normal weight. To our knowledge, there have not been any studies that have investigated the use of the Parker Flex-Tube for fiberoptic intubations in patients categorized as obese by BMI. Our hypothesis is that the Parker Flex-Tip ETT results in easier passage of the ETT over a fiberoptic scope during elective fiberoptic intubation of obese patients in comparison to a traditional ETT.
This is a randomized, double-blinded study. Neither the patient nor the anesthesia practitioner advancing the ETT will know the group to which the patient has been assigned. On the day of surgery, participants will be randomized 1:1 to one of two groups. Both groups will be electively intubated with a fiberoptic scope. One group will be intubated using a Parker-Flex endotracheal tube and the second group of will be intubated with a standard endotracheal tube. There will be an equal probability of being assigned to either group. No placebo or control group will be used. Randomization will be computer-generated and assignments will be enclosed in sealed envelopes to provide allocation concealment. The anesthesiology technician involved in the case will open the envelope at the start of the case and will not be blinded to the study, due to the fact that the technician must prepare the endotracheal tube for the fiberoptic intubation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parker Flex-Tip® Tracheal Tube | Active Comparator | Intubation of obese patients with the Parker Flex-Tip® Tracheal Tube |
|
| Portex® Tracheal Tube | Active Comparator | Intubation of obese patients with the Portex® Tracheal Tube |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parker Flex-Tip® tracheal tube | Device |
| ||
| Portex® Tracheal Tube |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Time Required for Successful Advancement of Endotracheal Tube Into Trachea | following successful intubation or lasting longer than 120 seconds |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Endotracheal Intubations Successful on First Attempt Attempts | following successful intubation or more than 5 attempts |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Failed Attempts of Placing Endotracheal Tube Into Trachea | The intent is to report the number of attempts required to successfully advance the endotracheal tube into the trachea. | following intubation attempt |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ben Taub General Hospital | Houston | Texas | 77030 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Parker Flex-Tip® Tracheal Tube | Intubation of obese patients with the Parker Flex-Tip® Tracheal Tube Parker Flex-Tip® tracheal tube |
| FG001 | Portex® Tracheal Tube | Intubation of obese patients with the Portex® Tracheal Tube Portex® Tracheal Tube |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Parker Flex-Tip® Tracheal Tube | Intubation of obese patients with the Parker Flex-Tip® Tracheal Tube Parker Flex-Tip® tracheal tube |
| BG001 | Portex® Tracheal Tube | Intubation of obese patients with the Portex® Tracheal Tube Portex® Tracheal Tube |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Length of Time Required for Successful Advancement of Endotracheal Tube Into Trachea | Posted | Median | Inter-Quartile Range | seconds | following successful intubation or lasting longer than 120 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 | Parker Flex-Tip® Tracheal Tube | Intubation of obese patients with the Parker Flex-Tip® Tracheal Tube Parker Flex-Tip® tracheal tube |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lee Chang | Baylor College of Medicine | 713-873-4321 | lcchang@bcm.edu |
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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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| Device |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Participants |
|
|
| Secondary | Percentage of Endotracheal Intubations Successful on First Attempt Attempts | Posted | Number | percentage of successful first attempts | following successful intubation or more than 5 attempts |
|
|
|
| Other Pre-specified | Number of Failed Attempts of Placing Endotracheal Tube Into Trachea | The intent is to report the number of attempts required to successfully advance the endotracheal tube into the trachea. | Not Posted | following intubation attempt | Participants |
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Portex® Tracheal Tube | Intubation of obese patients with the Portex® Tracheal Tube Portex® Tracheal Tube | 0 | 30 | 0 | 30 | 0 | 30 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |