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Completed

NCT Number: NCT01894178

Study Examining Parker-Flex Endotracheal Tube for 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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ben Taub General Hospital

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Parker Flex-Tip® tracheal tube

Device

Portex® Tracheal Tube

Device

Primary outcomes

  1. Length of Time Required for Successful Advancement of Endotracheal Tube Into Trachea

    Time frame: following successful intubation or lasting longer than 120 seconds

Secondary outcomes

  1. Percentage of Endotracheal Intubations Successful on First Attempt Attempts

    Time frame: following successful intubation or more than 5 attempts

Other outcomes

  1. Number of Failed Attempts of Placing Endotracheal Tube Into Trachea

    Time frame: following intubation attempt

    The intent is to report the number of attempts required to successfully advance the endotracheal tube into the trachea.

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jul 10, 2013
Registry last updated
Sep 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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