Trial Outcomes & Findings for Clinical Evaluation of the Storz CMAC Laryngoscope (NCT NCT00956592)

NCT ID: NCT00956592

Last Updated: 2018-04-05

Results Overview

Success was measured by confirmed tracheal tube placement with one attempt. Any removal of the laryngoscope blade constituted a failure

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 300 participants
• Primary outcome timeframe: During each intubation in a 14 month period
• Results posted on: 2018-04-05

Participant Flow

Patients were recruited at OHSU OR and procedure rooms. 300 patients were enrolled in the study from 10/09-12/10

4 exclusions were noted for failure to follow the randomization

Participant milestones

Measure	CMAC Video Laryngoscope Subjects will have their intubation attempted first with the CMAC video laryngoscope. Success is measured as confirmed tube placement with single blade insertion	Macintosh Blade Patients will have their first intubation attempted utilizing the conventional Macintosh design laryngoscope blade. Success is measured as confirmed tube placement with a single blade insertion
Overall Study STARTED	150	150
Overall Study COMPLETED	149	147
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Measure	CMAC Video Laryngoscope Subjects will have their intubation attempted first with the CMAC video laryngoscope. Success is measured as confirmed tube placement with single blade insertion	Macintosh Blade Patients will have their first intubation attempted utilizing the conventional Macintosh design laryngoscope blade. Success is measured as confirmed tube placement with a single blade insertion
Overall Study Protocol Violation	1	3

Baseline Characteristics

Clinical Evaluation of the Storz CMAC Laryngoscope

Baseline characteristics by cohort

Measure	CMAC Video Laryngoscope n=150 Participants Subjects will have their intubation attempted first with the CMAC video laryngoscope. Success is measured as confirmed tube placement with single blade insertion	Macintosh Blade n=150 Participants Patients will have their first intubation attempted utilizing the conventional Macintosh design laryngoscope blade. Success is measured as confirmed tube placement with a single blade insertion	Total n=300 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	122 Participants n=5 Participants	114 Participants n=7 Participants	236 Participants n=5 Participants
Age, Categorical >=65 years	28 Participants n=5 Participants	36 Participants n=7 Participants	64 Participants n=5 Participants
Age, Continuous	53.8 years STANDARD_DEVIATION 14.2 • n=5 Participants	55.4 years STANDARD_DEVIATION 14.5 • n=7 Participants	54.6 years STANDARD_DEVIATION 14.5 • n=5 Participants
Sex: Female, Male Female	76 Participants n=5 Participants	65 Participants n=7 Participants	141 Participants n=5 Participants
Sex: Female, Male Male	74 Participants n=5 Participants	85 Participants n=7 Participants	159 Participants n=5 Participants
Region of Enrollment United States	150 participants n=5 Participants	150 participants n=7 Participants	300 participants n=5 Participants

PRIMARY outcome

Timeframe: During each intubation in a 14 month period

Population: 4 patients of the 300 were excluded because the randomization was not followed due to unavailability of equipment or provider preference to remove patient from study

Success was measured by confirmed tracheal tube placement with one attempt. Any removal of the laryngoscope blade constituted a failure

Outcome measures

Measure	CMAC Video Laryngoscope n=149 Participants Subjects will have their intubation attempted first with the CMAC video laryngoscope. Success is measured as confirmed tube placement with single blade insertion	Macintosh Blade n=147 Participants Patients will have their first intubation attempted utilizing the conventional Macintosh design laryngoscope blade. Success is measured as confirmed tube placement with a single blade insertion
Measure of Intubation Success	138 Participants Interval 132.0 to 144.0	124 Participants Interval 117.0 to 131.0

SECONDARY outcome

Timeframe: During laryngoscopy procedure

Population: time

Time was measured as the duration of laryngoscopy defined by blade insertion to tracheal tube cuff inflation

Outcome measures

Measure	CMAC Video Laryngoscope n=149 Participants Subjects will have their intubation attempted first with the CMAC video laryngoscope. Success is measured as confirmed tube placement with single blade insertion	Macintosh Blade n=147 Participants Patients will have their first intubation attempted utilizing the conventional Macintosh design laryngoscope blade. Success is measured as confirmed tube placement with a single blade insertion
Intubation Time	46 seconds Interval 40.0 to 51.0	33 seconds Interval 29.0 to 36.0

SECONDARY outcome

Timeframe: 1 year

Outcome measures

Measure	CMAC Video Laryngoscope n=149 Participants Subjects will have their intubation attempted first with the CMAC video laryngoscope. Success is measured as confirmed tube placement with single blade insertion	Macintosh Blade n=147 Participants Patients will have their first intubation attempted utilizing the conventional Macintosh design laryngoscope blade. Success is measured as confirmed tube placement with a single blade insertion
Number of Participants Intubated With a Rescue Device	6 participants	12 participants

SECONDARY outcome

Timeframe: 1 year

Outcome measures

Measure	CMAC Video Laryngoscope n=147 Participants Subjects will have their intubation attempted first with the CMAC video laryngoscope. Success is measured as confirmed tube placement with single blade insertion	Macintosh Blade n=149 Participants Patients will have their first intubation attempted utilizing the conventional Macintosh design laryngoscope blade. Success is measured as confirmed tube placement with a single blade insertion
Number of Participants With Complications	35 Participants	26 Participants

SECONDARY outcome

Timeframe: 1 year

Grade 1= full view of the glottis achieved Grade 2= partial view of the glottis achieved Grade 3= only the epiglottis visualized Grade 4= no laryngeal view achieved

Outcome measures

Measure	CMAC Video Laryngoscope n=149 Participants Subjects will have their intubation attempted first with the CMAC video laryngoscope. Success is measured as confirmed tube placement with single blade insertion	Macintosh Blade n=147 Participants Patients will have their first intubation attempted utilizing the conventional Macintosh design laryngoscope blade. Success is measured as confirmed tube placement with a single blade insertion
Number of Participants With a Laryngeal View Grade of 1 or 2 vs. 3 or 4. Grade I view achieved	103 Participants	72 Participants
Number of Participants With a Laryngeal View Grade of 1 or 2 vs. 3 or 4. Grade 2 view achieved	36 Participants	47 Participants
Number of Participants With a Laryngeal View Grade of 1 or 2 vs. 3 or 4. Grade 3 view achieved	9 Participants	26 Participants
Number of Participants With a Laryngeal View Grade of 1 or 2 vs. 3 or 4. Grade 4 view achieved	1 Participants	2 Participants

SECONDARY outcome

Timeframe: 1 year

Population: Use of bougie or external manipulation

Outcome measures

Measure	CMAC Video Laryngoscope n=138 Participants Subjects will have their intubation attempted first with the CMAC video laryngoscope. Success is measured as confirmed tube placement with single blade insertion	Macintosh Blade n=124 Participants Patients will have their first intubation attempted utilizing the conventional Macintosh design laryngoscope blade. Success is measured as confirmed tube placement with a single blade insertion
Number of Particpants Requiring Adjuncts to Assist Intubation	33 Participants	46 Participants

Adverse Events

CMAC Video Laryngoscope

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Macintosh Blade

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

Michael Aziz

Oregon Health & Science University

Phone: 503-494-5581

Email: azizm@ohsu.edu

Results disclosure agreements

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