Study Examining Parker-Flex Endotracheal Tube for Obese Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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STUDY EVALUATING THE PARKER-FLEX ENDOTRACHEAL TUBE FOR FIBEROPTIC INTUBATION ON OBESE PATIENTS

Conditions
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Obesity

Intervention / Treatment
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* Device: Parker Flex-Tip® tracheal tube
* Device: Portex® Tracheal Tube


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI of 30 or greater American Society of Anesthesiologists (ASA) Physical Status Classification I- III Patients scheduled for elective procedures requiring general anesthesia and endotracheal intubation. Exclusion Criteria: Predicted difficult airway based on physical exam and patient's history Rapid sequence intubation indicated (patients who require to be intubated as quickly as possible) Prior trauma or surgery in the oropharynx/larynx Known abnormal laryngeal structures (tumors) Infectious and toxic conditions Cervical spine instability Emergency surgery

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Parker Flex-Tip® Tracheal Tube<br>Intubation of obese patients with the Parker Flex-Tip® Tracheal Tube | Device: Parker Flex-Tip® tracheal tube<br> <br> |
| Active Comparator: Portex® Tracheal Tube<br>Intubation of obese patients with the Portex® Tracheal Tube | Device: Portex® Tracheal Tube<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Endotracheal Intubations Successful on First Attempt Attempts |  | following successful intubation or more than 5 attempts |