NCT01894178

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Jul 2013

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2013

Completed
Same day until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 10, 2013

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
3 years until next milestone

Results Posted

Study results publicly available

September 24, 2019

Completed
Last Updated

September 24, 2019

Status Verified

August 1, 2019

Enrollment Period

3.3 years

First QC Date

July 1, 2013

Results QC Date

August 28, 2018

Last Update Submit

August 30, 2019

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • Length of Time Required for Successful Advancement of Endotracheal Tube Into Trachea

    following successful intubation or lasting longer than 120 seconds

Secondary Outcomes (1)

  • Percentage of Endotracheal Intubations Successful on First Attempt Attempts

    following successful intubation or more than 5 attempts

Other Outcomes (1)

  • Number of Failed Attempts of Placing Endotracheal Tube Into Trachea

    following intubation attempt

Study Arms (2)

Parker Flex-Tip® Tracheal Tube

ACTIVE COMPARATOR

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

Device: Parker Flex-Tip® tracheal tube

Portex® Tracheal Tube

ACTIVE COMPARATOR

Intubation of obese patients with the Portex® Tracheal Tube

Device: Portex® Tracheal Tube

Interventions

Parker Flex-Tip® tracheal tubeDEVICE
Parker Flex-Tip® Tracheal Tube
Portex® Tracheal TubeDEVICE
Portex® Tracheal Tube

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ben Taub General Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Lee Chang
Organization
Baylor College of Medicine
lcchang@bcm.edu
713-873-4321

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 1, 2013

First Posted

July 10, 2013

Study Start

July 1, 2013

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

September 24, 2019

Results First Posted

September 24, 2019

Record last verified: 2019-08

Locations

US(1)