Clinical Evaluation of the Storz CMAC Laryngoscope

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Intubation Airway Management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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CMAC Video laryngoscope

Subjects will have their intubation attempted first with the CMAC video laryngoscope

Group Type ACTIVE_COMPARATOR

CMAC video laryngoscope

Intervention Type DEVICE

Intubation utilizing the assistance of video enhancement

Macintosh blade

Patients will have their first intubation attempted utilizing the conventional Macintosh design laryngoscope blade

Group Type ACTIVE_COMPARATOR

Macintosh laryngoscope

Intervention Type DEVICE

Patients will be intubated utilizing either a Macintosh 3 or Macintosh 4 designed blade

Interventions

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CMAC video laryngoscope

Intubation utilizing the assistance of video enhancement

Intervention Type DEVICE

Macintosh laryngoscope

Patients will be intubated utilizing either a Macintosh 3 or Macintosh 4 designed blade

Intervention Type DEVICE

Other Intervention Names

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CMAC Storz laryngoscope Mac blade

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No