Clinical Evaluation of the Storz CMAC Laryngoscope

• Sponsor: Oregon Health and Science University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00956592
• Collaborator: (none)
• Enrollment: 300
• Location: 1
• Arms: 2
• Duration (Months): 14
• Patients Per Site Per Month: 21.4

Study Details

Study Description

Brief Summary

This study aims to evaluate the utility of a video assisted device for intubation (placement of a breathing tube) during surgery. This study specifically aims to compare a video assisted intubation with the CMAC laryngoscope to conventional devices in the setting of intubations predicted to be difficult.

Condition or Disease	Intervention/Treatment	Phase
Intubation; Airway Management	Device: CMAC video laryngoscope; Device: Macintosh laryngoscope	N/A

Detailed Description

Patients will be specifically screened for predictors by history and physical exam of potential airway difficulty. The role of video laryngoscopy in airways predicted to be difficult is poorly defined. This study aims to recognize if video laryngoscopy is more useful than conventional laryngoscopy as a first attempt for those with anticipated difficulty.

Study Design

• Study Type: Interventional
• Actual Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized Control Trial to Determine First Attempt Intubation Success With the CMAC Laryngoscope vs. Macintosh Blade in Airways Predicted to be Difficult
• Study Start Date: Oct 1, 2009
• Actual Primary Completion Date: Dec 1, 2010
• Actual Study Completion Date: Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: CMAC Video laryngoscope Subjects will have their intubation attempted first with the CMAC video laryngoscope	Device: CMAC video laryngoscope; Intubation utilizing the assistance of video enhancement; Other Names: CMAC Storz laryngoscope
Active Comparator: Macintosh blade Patients will have their first intubation attempted utilizing the conventional Macintosh design laryngoscope blade	Device: Macintosh laryngoscope; Patients will be intubated utilizing either a Macintosh 3 or Macintosh 4 designed blade; Other Names: Mac blade

Outcome Measures

Primary Outcome Measures

1. Measure of Intubation Success [During each intubation in a 14 month period]

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

Secondary Outcome Measures

1. Intubation Time [During laryngoscopy procedure]

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

2. Number of Participants Intubated With a Rescue Device [1 year]

3. Number of Participants With Complications [1 year]

4. Number of Participants With a Laryngeal View Grade of 1 or 2 vs. 3 or 4. [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

5. Number of Particpants Requiring Adjuncts to Assist Intubation [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Adult patients presenting for elective surgery who are fasted and who have one of the following difficult airway predictors:

• mallampati classification 3

• mallampati classification 4

• Reduced mouth opening (<3cm)

• reduced cervical motion

• history of previous difficult intubation or multiple laryngoscopy attempts

Exclusion Criteria:

• Patients less than 18 years old, patients who are not fasted (>6 hrs. NPO)

• Patients who have contraindications to the administration of neuromuscular blocking drugs

• Patients who have a documented history of intubation on first attempt with C-L grade 1 laryngeal view

• Patients who are deemed to difficult and dangerous to anesthetize without first securing an airway.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oregon Health & Science University	Portland	Oregon	United States	97239

Sponsors and Collaborators

• Oregon Health and Science University

Investigators

• Principal Investigator: Michael Aziz, MD, Oregon Health and Science University

Study Documents (Full-Text)

None provided.

More Information

Publications

• Jungbauer A, Schumann M, Brunkhorst V, Börgers A, Groeben H. Expected difficult tracheal intubation: a prospective comparison of direct laryngoscopy and video laryngoscopy in 200 patients. Br J Anaesth. 2009 Apr;102(4):546-50. doi: 10.1093/bja/aep013. Epub 2009 Feb 20.

• Responsible Party: Michael Aziz, Associate Professor Department of Anesthesiology & Perioperative Medicine, Oregon Health and Science University
• ClinicalTrials.gov Identifier: NCT00956592
• Other Study ID Numbers: IRB00003272
• First Posted: Aug 11, 2009
• Last Update Posted: Apr 5, 2018
• Last Verified: Apr 1, 2018

• Keywords provided by Michael Aziz, Associate Professor Department of Anesthesiology & Perioperative Medicine, Oregon Health and Science University: Video laryngoscopy; Intubation success; Difficult airway; CMAC laryngoscope

Study Results

Participant Flow

Recruitment Details	Patients were recruited at OHSU OR and procedure rooms. 300 patients were enrolled in the study from 10/09-12/10
Pre-assignment Detail	4 exclusions were noted for failure to follow the randomization

Arm/Group Title	CMAC Video Laryngoscope	Macintosh Blade
Arm/Group Description	Subjects will have their intubation attempted first with the CMAC video laryngoscope. Success is measured as confirmed tube placement with single blade insertion	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
Period Title: Overall Study
STARTED	150	150
COMPLETED	149	147
NOT COMPLETED	1	3

Baseline Characteristics

Arm/Group Title	CMAC Video Laryngoscope	Macintosh Blade	Total
Arm/Group Description	Subjects will have their intubation attempted first with the CMAC video laryngoscope. Success is measured as confirmed tube placement with single blade insertion	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 of all reporting groups
Overall Participants	150	150	300
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	122 81.3%	114 76%	236 78.7%
>=65 years	28 18.7%	36 24%	64 21.3%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	53.8 (14.2)	55.4 (14.5)	54.6 (14.5)
Sex: Female, Male (Count of Participants)
Female	76 50.7%	65 43.3%	141 47%
Male	74 49.3%	85 56.7%	159 53%
Region of Enrollment (participants) [Number]
United States	150 100%	150 100%	300 100%

Outcome Measures

1. Primary Outcome

Title	Measure of Intubation Success
Description	Success was measured by confirmed tracheal tube placement with one attempt. Any removal of the laryngoscope blade constituted a failure
Time Frame	During each intubation in a 14 month period

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	CMAC Video Laryngoscope	Macintosh Blade
Arm/Group Description	Subjects will have their intubation attempted first with the CMAC video laryngoscope. Success is measured as confirmed tube placement with single blade insertion	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 Participants	149	147
Number (95% Confidence Interval) [Participants]	138 92%	124 82.7%

2. Secondary Outcome

Title	Intubation Time
Description	Time was measured as the duration of laryngoscopy defined by blade insertion to tracheal tube cuff inflation
Time Frame	During laryngoscopy procedure

Outcome Measure Data

Analysis Population Description

time

Arm/Group Title	CMAC Video Laryngoscope	Macintosh Blade
Arm/Group Description	Subjects will have their intubation attempted first with the CMAC video laryngoscope CMAC video laryngoscope: Intubation utilizing the assistance of video enhancement	Patients will have their first intubation attempted utilizing the conventional Macintosh design laryngoscope blade Macintosh laryngoscope: Patients will be intubated utilizing either a Macintosh 3 or Macintosh 4 designed blade
Measure Participants	149	147
Mean (90% Confidence Interval) [seconds]	46	33

3. Secondary Outcome

Title	Number of Participants Intubated With a Rescue Device
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CMAC Video Laryngoscope	Macintosh Blade
Arm/Group Description	Subjects will have their intubation attempted first with the CMAC video laryngoscope CMAC video laryngoscope: Intubation utilizing the assistance of video enhancement	Patients will have their first intubation attempted utilizing the conventional Macintosh design laryngoscope blade Macintosh laryngoscope: Patients will be intubated utilizing either a Macintosh 3 or Macintosh 4 designed blade
Measure Participants	149	147
Number [participants]	6 4%	12 8%

4. Secondary Outcome

Title	Number of Participants With Complications
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CMAC Video Laryngoscope	Macintosh Blade
Arm/Group Description	Subjects will have their intubation attempted first with the CMAC video laryngoscope CMAC video laryngoscope: Intubation utilizing the assistance of video enhancement	Patients will have their first intubation attempted utilizing the conventional Macintosh design laryngoscope blade Macintosh laryngoscope: Patients will be intubated utilizing either a Macintosh 3 or Macintosh 4 designed blade
Measure Participants	147	149
Count of Participants [Participants]	35 23.3%	26 17.3%

5. Secondary Outcome

Title	Number of Participants With a Laryngeal View Grade of 1 or 2 vs. 3 or 4.
Description	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
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CMAC Video Laryngoscope	Macintosh Blade
Arm/Group Description	Subjects will have their intubation attempted first with the CMAC video laryngoscope CMAC video laryngoscope: Intubation utilizing the assistance of video enhancement	Patients will have their first intubation attempted utilizing the conventional Macintosh design laryngoscope blade Macintosh laryngoscope: Patients will be intubated utilizing either a Macintosh 3 or Macintosh 4 designed blade
Measure Participants	149	147
Grade I view achieved	103 68.7%	72 48%
Grade 2 view achieved	36 24%	47 31.3%
Grade 3 view achieved	9 6%	26 17.3%
Grade 4 view achieved	1 0.7%	2 1.3%

6. Secondary Outcome

Title	Number of Particpants Requiring Adjuncts to Assist Intubation
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Use of bougie or external manipulation

Arm/Group Title	CMAC Video Laryngoscope	Macintosh Blade
Arm/Group Description	Subjects will have their intubation attempted first with the CMAC video laryngoscope CMAC video laryngoscope: Intubation utilizing the assistance of video enhancement	Patients will have their first intubation attempted utilizing the conventional Macintosh design laryngoscope blade Macintosh laryngoscope: Patients will be intubated utilizing either a Macintosh 3 or Macintosh 4 designed blade
Measure Participants	138	124
Count of Participants [Participants]	33 22%	46 30.7%

Adverse Events

Arm/Group Title	CMAC Video Laryngoscope		Macintosh Blade
Arm/Group Description	Subjects will have their intubation attempted first with the CMAC video laryngoscope. Success is measured as confirmed tube placement with single blade insertion		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
All Cause Mortality
	CMAC Video Laryngoscope		Macintosh Blade
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	CMAC Video Laryngoscope		Macintosh Blade
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/150 (0%)		0/150 (0%)
Other (Not Including Serious) Adverse Events
	CMAC Video Laryngoscope		Macintosh Blade
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/150 (0%)		0/150 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE 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.