Trial Outcomes & Findings for Comparison Between the Fastrach and CTrach Laryngeal Mask Airway (NCT NCT00814775)

NCT ID: NCT00814775

Last Updated: 2016-10-17

Results Overview

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 43 participants
• Primary outcome timeframe: from start of intubation to successfully intubated
• Results posted on: 2016-10-17

Participant Flow

Participant milestones

Measure	Fastrach Fastrach Laryngeal Mask Airway intubation Fastrach Laryngeal Mask: Intubation of difficult airway using Fastrach Laryngeal Mask	CTrach Intubation of difficult airway using CTrach Laryngeal Mask CTrach Laryngeal Mask: CTrach Laryngeal Mask intubation
Overall Study STARTED	23	20
Overall Study COMPLETED	23	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison Between the Fastrach and CTrach Laryngeal Mask Airway

Baseline characteristics by cohort

Measure	Fastrach n=23 Participants Fastrach Laryngeal Mask Airway intubation Fastrach Laryngeal Mask: Intubation of difficult airway using Fastrach Laryngeal Mask	CTrach n=20 Participants Intubation of difficult airway using CTrach Laryngeal Mask CTrach Laryngeal Mask: CTrach Laryngeal Mask intubation	Total n=43 Participants Total of all reporting groups
Age, Continuous	58 years STANDARD_DEVIATION 16 • n=93 Participants	59 years STANDARD_DEVIATION 15 • n=4 Participants	59 years STANDARD_DEVIATION 16 • n=27 Participants
Sex: Female, Male Female	8 Participants n=93 Participants	9 Participants n=4 Participants	17 Participants n=27 Participants
Sex: Female, Male Male	15 Participants n=93 Participants	11 Participants n=4 Participants	26 Participants n=27 Participants

PRIMARY outcome

Timeframe: from start of intubation to successfully intubated

Outcome measures

Measure	Fastrach n=23 Participants Fastrach Laryngeal Mask Airway intubation Fastrach Laryngeal Mask: Intubation of difficult airway using Fastrach Laryngeal Mask	CTrach n=20 Participants Intubation of difficult airway using CTrach Laryngeal Mask CTrach Laryngeal Mask: CTrach Laryngeal Mask intubation
To Compare the Time Required for Successful Intubation Between the Fastrach and CTrach LMA Devices in Patients With a Mallampati Score III and IV Without Use of Fiberoptic Bronchoscopy	41 seconds Interval 31.0 to 78.0	40 seconds Interval 32.0 to 55.0

PRIMARY outcome

Timeframe: 60 seconds

Outcome measures

Measure	Fastrach n=23 Participants Fastrach Laryngeal Mask Airway intubation Fastrach Laryngeal Mask: Intubation of difficult airway using Fastrach Laryngeal Mask	CTrach n=20 Participants Intubation of difficult airway using CTrach Laryngeal Mask CTrach Laryngeal Mask: CTrach Laryngeal Mask intubation
To Compare the Time Required for Successful Intubation Between the Fastrach and CTrach LMA Devices in Patients With a Mallampati Score III and IV Use of Fiberoptic Bronchoscopy	35 seconds Interval 28.0 to 43.0	40 seconds Interval 32.0 to 51.0

Adverse Events

Fastrach

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

CTrach

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

Roberta Johnson

Cleveland Clinic

Phone: 216-444-9950

Email: johnsor13@ccf.org

Results disclosure agreements

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