Study Examining Parker-Flex Endotracheal Tube for Obese Patients

• Sponsor: Baylor College of Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT01894178
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Duration (Months): 39
• Patients Per Site Per Month: 1.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Device: Parker Flex-Tip® tracheal tube; Device: Portex® Tracheal Tube	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: STUDY EVALUATING THE PARKER-FLEX ENDOTRACHEAL TUBE FOR FIBEROPTIC INTUBATION ON OBESE PATIENTS
• Study Start Date: Jul 1, 2013
• Actual Primary Completion Date: Oct 1, 2016
• Actual Study Completion Date: Oct 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Length of Time Required for Successful Advancement of Endotracheal Tube Into Trachea [following successful intubation or lasting longer than 120 seconds]

Secondary Outcome Measures

1. Percentage of Endotracheal Intubations Successful on First Attempt Attempts [following successful intubation or more than 5 attempts]

Other Outcome Measures

1. Number of Failed Attempts of Placing Endotracheal Tube Into Trachea [following intubation attempt]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ben Taub General Hospital	Houston	Texas	United States	77030

Sponsors and Collaborators

• Baylor College of Medicine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lee Chang, Assistant Professor, Baylor College of Medicine
• ClinicalTrials.gov Identifier: NCT01894178
• Other Study ID Numbers: H-31550
• First Posted: Jul 10, 2013
• Last Update Posted: Sep 24, 2019
• Last Verified: Aug 1, 2019

Study Results

Participant Flow

Arm/Group Title	Parker Flex-Tip® Tracheal Tube	Portex® Tracheal Tube
Arm/Group Description	Intubation of obese patients with the Parker Flex-Tip® Tracheal Tube Parker Flex-Tip® tracheal tube	Intubation of obese patients with the Portex® Tracheal Tube Portex® Tracheal Tube
Period Title: Overall Study
STARTED	30	30
COMPLETED	30	30
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Parker Flex-Tip® Tracheal Tube	Portex® Tracheal Tube	Total
Arm/Group Description	Intubation of obese patients with the Parker Flex-Tip® Tracheal Tube Parker Flex-Tip® tracheal tube	Intubation of obese patients with the Portex® Tracheal Tube Portex® Tracheal Tube	Total of all reporting groups
Overall Participants	30	30	60
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	30 100%	30 100%	60 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	22 73.3%	21 70%	43 71.7%
Male	8 26.7%	9 30%	17 28.3%

Outcome Measures

1. Primary Outcome

Title	Length of Time Required for Successful Advancement of Endotracheal Tube Into Trachea
Time Frame	following successful intubation or lasting longer than 120 seconds

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Parker Flex-Tip® Tracheal Tube	Portex® Tracheal Tube
Arm/Group Description	Intubation of obese patients with the Parker Flex-Tip® Tracheal Tube Parker Flex-Tip® tracheal tube	Intubation of obese patients with the Portex® Tracheal Tube Portex® Tracheal Tube
Measure Participants	30	30
Median (Inter-Quartile Range) [seconds]	6.36	8.81

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Parker Flex-Tip® Tracheal Tube	Portex® Tracheal Tube
Arm/Group Description	Intubation of obese patients with the Parker Flex-Tip® Tracheal Tube Parker Flex-Tip® tracheal tube	Intubation of obese patients with the Portex® Tracheal Tube Portex® Tracheal Tube
Measure Participants	30	30
Number [percentage of successful first attempts]	62	73

3. Other Pre-specified Outcome

Title	Number of Failed Attempts of Placing Endotracheal Tube Into Trachea
Description	The intent is to report the number of attempts required to successfully advance the endotracheal tube into the trachea.
Time Frame	following intubation attempt

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	Parker Flex-Tip® Tracheal Tube		Portex® Tracheal Tube
Arm/Group Description	Intubation of obese patients with the Parker Flex-Tip® Tracheal Tube Parker Flex-Tip® tracheal tube		Intubation of obese patients with the Portex® Tracheal Tube Portex® Tracheal Tube
All Cause Mortality
	Parker Flex-Tip® Tracheal Tube		Portex® Tracheal Tube
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)
Serious Adverse Events
	Parker Flex-Tip® Tracheal Tube		Portex® Tracheal Tube
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)
Other (Not Including Serious) Adverse Events
	Parker Flex-Tip® Tracheal Tube		Portex® Tracheal Tube
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.