Study Examining Parker-Flex Endotracheal Tube for Obese Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Device: Parker Flex-Tip® tracheal tube; Device: Portex® Tracheal Tube

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Ben Taub General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Baylor College of Medicine

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: July 1, 2013
• First Submitted That Met QC Criteria: July 3, 2013
• First Posted (Estimate): July 10, 2013

Study Record Updates

• Last Update Posted (Actual): September 24, 2019
• Last Update Submitted That Met QC Criteria: August 30, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: H-31550