Clinical Evaluation of the Storz CMAC Laryngoscope

Intubation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00956592
• Other study ID #: IRB00003272
• Status: Completed
• Phase: N/A
• First received: August 10, 2009
• Last updated: April 3, 2018
• Start date: October 2009
• Est. completion date: December 2010

Study information

• Verified date: April 2018
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Airway Management
• Intubation

Intervention

Device:
• CMAC video laryngoscope
Intubation utilizing the assistance of video enhancement
• Macintosh laryngoscope
Patients will be intubated utilizing either a Macintosh 3 or Macintosh 4 designed blade

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure of Intubation Success	Success was measured by confirmed tracheal tube placement with one attempt. Any removal of the laryngoscope blade constituted a failure	During each intubation in a 14 month period
Secondary	Intubation Time	Time was measured as the duration of laryngoscopy defined by blade insertion to tracheal tube cuff inflation	During laryngoscopy procedure
Secondary	Number of Participants Intubated With a Rescue Device		1 year
Secondary	Number of Participants With Complications		1 year
Secondary	Number of Participants With a Laryngeal View Grade of 1 or 2 vs. 3 or 4.	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	1 year
Secondary	Number of Particpants Requiring Adjuncts to Assist Intubation		1 year