Study Examining Parker-Flex Endotracheal Tube for Obese Patients

NCT ID: NCT01894178

Last Updated: 2019-09-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2016-10-31

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Parker Flex-Tip® Tracheal Tube

Intubation of obese patients with the Parker Flex-Tip® Tracheal Tube

Group Type: ACTIVE_COMPARATOR

Parker Flex-Tip® tracheal tube

Intervention Type: DEVICE

Portex® Tracheal Tube

Intubation of obese patients with the Portex® Tracheal Tube

Group Type: ACTIVE_COMPARATOR

Portex® Tracheal Tube

Intervention Type: DEVICE

Interventions

Parker Flex-Tip® tracheal tube

Intervention Type: DEVICE

Portex® Tracheal Tube

Intervention Type: DEVICE

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Lee Chang

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ben Taub General Hospital

Houston, Texas, United States

Countries

United States

Other Identifiers

H-31550

Identifier Type: -

Identifier Source: org_study_id