Clinical trial NCT00956592: Clinical Evaluation of the Storz CMAC Laryngoscope
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation
Airway Management
Keywords: Video laryngoscopy
Intubation success
Difficult airway
CMAC laryngoscope
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2009-08-11
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Measure of Intubation Success
timeFrame: During each intubation in a 14 month period
Secondary outcomes:
measure: Intubation Time
timeFrame: During laryngoscopy procedure
measure: Number of Participants Intubated With a Rescue Device
timeFrame: 1 year
measure: Number of Participants With Complications
timeFrame: 1 year
measure: Number of Participants With a Laryngeal View Grade of 1 or 2 vs. 3 or 4.
timeFrame: 1 year
measure: Number of Particpants Requiring Adjuncts to Assist Intubation
timeFrame: 1 year
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Michael Aziz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jungbauer A, Schumann M, Brunkhorst V, Borgers 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.