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
  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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 16, 2014