Clinical trial NCT01894178: Study Examining Parker-Flex Endotracheal Tube for Obese Patients
Official title: STUDY EVALUATING THE PARKER-FLEX ENDOTRACHEAL TUBE FOR FIBEROPTIC INTUBATION ON OBESE PATIENTS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2013-07-10
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Length of Time Required for Successful Advancement of Endotracheal Tube Into Trachea
timeFrame: following successful intubation or lasting longer than 120 seconds
Secondary outcomes:
measure: Percentage of Endotracheal Intubations Successful on First Attempt Attempts
timeFrame: following successful intubation or more than 5 attempts
Other outcomes:
measure: Number of Failed Attempts of Placing Endotracheal Tube Into Trachea
timeFrame: following intubation attempt
Locations:
city: Houston
country: United States
facility: Ben Taub General Hospital
state: Texas
Study officials:
References: