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Initial Experience With Storz C-MAC Video Intubation System

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Davide Cattano, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT01104090
First received: April 13, 2010
Last updated: June 17, 2013
Last verified: June 2013
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Official Title: Initial Experience With Storz C-MAC Video Intubation System

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

Primary Outcome Measures:
  • Time for Intubation [ Time Frame: Intubation time ] [ Designated as safety issue: No ]
    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
Other Name: C-MAC direct 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
Other Name: C-MAC indirect laryngoscopy

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: April 13, 2010
Last Updated: June 17, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on June 18, 2013