Clinical Evaluation of the Storz CMAC Laryngoscope

Not Applicable

Completed

• Conditions: Intubation; Airway Management
• Interventions: Device: Macintosh laryngoscope; Device: CMAC video laryngoscope

• Registration Number: NCT00956592
• Lead Sponsor: Oregon Health and Science University

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.

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 Timeline

• Study First Submitted: 2009-08-10
• Study First Submitted QC: 2009-08-10
• Study First Posted: 2009-08-11
• Study Start: 2009-10
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Results First Submitted: 2011-01-25
• Results First Submitted QC: 2011-02-14
• Results First Posted: 2011-03-09
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-03
• Last Update Posted: 2018-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Macintosh blade	Macintosh laryngoscope	Patients will have their first intubation attempted utilizing the conventional Macintosh design laryngoscope blade
CMAC Video laryngoscope	CMAC video laryngoscope	Subjects will have their intubation attempted first with the CMAC video laryngoscope

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Intubation Time	During laryngoscopy procedure	Time was measured as the duration of laryngoscopy defined by blade insertion to tracheal tube cuff inflation
Number of Participants Intubated With a Rescue Device	1 year
Number of Participants With Complications	1 year
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
Number of Particpants Requiring Adjuncts to Assist Intubation	1 year

Trial Locations

Locations (1)

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States