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Initial Experience With Storz C-MAC Video Intubation System (C-MAC)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01104090
First Posted: April 15, 2010
Last Update Posted: June 19, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Davide Cattano, The University of Texas Health Science Center, Houston
  Purpose

The purpose of this study is to determine the safety and efficacy of the C-MAC (Karl Storz Endoscopy, Inc., Tuttlingen, Germany) video intubation system guided intubation techniques.

We hypothesize that the C-MAC video laryngoscope is safe and efficacious in terms of successful endotracheal intubation. The C-MAC may be a safe and suitable alternative device for routine and difficult laryngoscopy and tracheal intubation. This is the first study to investigate the performance of C-MAC in clinical practice.


Condition Intervention Phase
Intubation; Difficult Device: C-MAC direct laryngoscopy Device: C-MAC Indirect laryngoscopy Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Official Title: Initial Experience With Storz C-MAC Video Intubation System

Resource links provided by NLM:


Further study details as provided by Davide Cattano, The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • Time for Intubation [ Time Frame: Intubation time ]
    Time taken for successful placement of endotracheal tube


Enrollment: 50
Study Start Date: February 2010
Study Completion Date: February 2012
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: C-MAC direct laryngoscopy
The laryngoscopy is performed with the CMAC used as Macintosh blade
Device: C-MAC direct laryngoscopy
Patients assigned to this arm will be intubated using C-MAC with direct laryngoscopy first and later indirect laryngoscopy
Experimental: C-MAC Indirect laryngoscopy
The CMAC is used as videolaryngoscope
Device: C-MAC Indirect laryngoscopy
Patients for this arm will be intubated with C-MAC using indirect technique

  Show Detailed Description

  Eligibility

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18 - 80 years of age
  • ASA I - III
  • Mallampati I-III
  • Mouthopening > 4cm

Exclusion Criteria:

  • Age < 18 years and > 80 years of age
  • ASA IV - V
  • Mallampati IV - V
  • Mouthopening < 4cm
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01104090


Locations
United States, Texas
Memorial Hermann Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: Davide Cattano, MD, PhD University of Texas Medical School at Houston
  More Information

Responsible Party: Davide Cattano, Associate Professor - Anesthesiology, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01104090     History of Changes
Other Study ID Numbers: HSC-MS-09-0161
First Submitted: April 13, 2010
First Posted: April 15, 2010
Last Update Posted: June 19, 2013
Last Verified: June 2013

Keywords provided by Davide Cattano, The University of Texas Health Science Center, Houston:
C-MAC
direct laryngoscopy
indirect laryngoscopy
to determine the safety and efficacy of the C-MAC