Obesity
Conditions
Brief summary
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
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.
Interventions
DEVICEParker Flex-Tip® tracheal tube
DEVICEPortex® Tracheal Tube
Sponsors
Baylor College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Length of Time Required for Successful Advancement of Endotracheal Tube Into Trachea | following successful intubation or lasting longer than 120 seconds |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Endotracheal Intubations Successful on First Attempt Attempts | following successful intubation or more than 5 attempts |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Failed Attempts of Placing Endotracheal Tube Into Trachea | following intubation attempt | The intent is to report the number of attempts required to successfully advance the endotracheal tube into the trachea. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Parker Flex-Tip® Tracheal Tube Intubation of obese patients with the Parker Flex-Tip® Tracheal Tube
Parker Flex-Tip® tracheal tube | 30 |
| Portex® Tracheal Tube Intubation of obese patients with the Portex® Tracheal Tube
Portex® Tracheal Tube | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | Parker Flex-Tip® Tracheal Tube | Portex® Tracheal Tube | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants | 30 Participants | 60 Participants |
| Sex: Female, Male Female | 22 Participants | 21 Participants | 43 Participants |
| Sex: Female, Male Male | 8 Participants | 9 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Length of Time Required for Successful Advancement of Endotracheal Tube Into Trachea
Time frame: following successful intubation or lasting longer than 120 seconds
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Parker Flex-Tip® Tracheal Tube | Length of Time Required for Successful Advancement of Endotracheal Tube Into Trachea | 6.36 seconds |
| Portex® Tracheal Tube | Length of Time Required for Successful Advancement of Endotracheal Tube Into Trachea | 8.81 seconds |
Secondary
Percentage of Endotracheal Intubations Successful on First Attempt Attempts
Time frame: following successful intubation or more than 5 attempts
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Parker Flex-Tip® Tracheal Tube | Percentage of Endotracheal Intubations Successful on First Attempt Attempts | 62 percentage of successful first attempts |
| Portex® Tracheal Tube | Percentage of Endotracheal Intubations Successful on First Attempt Attempts | 73 percentage of successful first 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.
Time frame: following intubation attempt