Trial Outcomes & Findings for Study Examining Parker-Flex Endotracheal Tube for Obese Patients (NCT NCT01894178)

NCT ID: NCT01894178

Last Updated: 2019-09-24

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 60 participants
• Primary outcome timeframe: following successful intubation or lasting longer than 120 seconds
• Results posted on: 2019-09-24

Participant Flow

Participant milestones

Measure	Parker Flex-Tip® Tracheal Tube Intubation of obese patients with the Parker Flex-Tip® Tracheal Tube Parker Flex-Tip® tracheal tube	Portex® Tracheal Tube Intubation of obese patients with the Portex® Tracheal Tube Portex® Tracheal Tube
Overall Study STARTED	30	30
Overall Study COMPLETED	30	30
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study Examining Parker-Flex Endotracheal Tube for Obese Patients

Baseline characteristics by cohort

Measure	Parker Flex-Tip® Tracheal Tube n=30 Participants Intubation of obese patients with the Parker Flex-Tip® Tracheal Tube Parker Flex-Tip® tracheal tube	Portex® Tracheal Tube n=30 Participants Intubation of obese patients with the Portex® Tracheal Tube Portex® Tracheal Tube	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	21 Participants n=7 Participants	43 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants

PRIMARY outcome

Timeframe: following successful intubation or lasting longer than 120 seconds

Outcome measures

Measure	Parker Flex-Tip® Tracheal Tube n=30 Participants Intubation of obese patients with the Parker Flex-Tip® Tracheal Tube Parker Flex-Tip® tracheal tube	Portex® Tracheal Tube n=30 Participants Intubation of obese patients with the Portex® Tracheal Tube Portex® Tracheal Tube
Length of Time Required for Successful Advancement of Endotracheal Tube Into Trachea	6.36 seconds Interval 5.0 to 10.4	8.81 seconds Interval 5.3 to 14.2

SECONDARY outcome

Timeframe: following successful intubation or more than 5 attempts

Outcome measures

Measure	Parker Flex-Tip® Tracheal Tube n=30 Participants Intubation of obese patients with the Parker Flex-Tip® Tracheal Tube Parker Flex-Tip® tracheal tube	Portex® Tracheal Tube n=30 Participants Intubation of obese patients with the Portex® Tracheal Tube Portex® Tracheal Tube
Percentage of Endotracheal Intubations Successful on First Attempt Attempts	62 percentage of successful first attempts	73 percentage of successful first attempts

OTHER_PRE_SPECIFIED outcome

Timeframe: following intubation attempt

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

Outcome measures

Outcome data not reported

Adverse Events

Parker Flex-Tip® Tracheal Tube

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Portex® Tracheal Tube

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Lee Chang

Baylor College of Medicine

Phone: 713-873-4321

Email: lcchang@bcm.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place