Comparison of Storz C-MAC and D-MAC Orotracheal Intubation Systems in Morbidly Obese Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Davide Cattano, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT01556061
First received: March 1, 2012
Last updated: April 25, 2014
Last verified: April 2014
  Purpose

The investigators hypothesize that the D-MAC (Dblade with C-MAC system) may be a suitable alternative device for difficult laryngoscopy and tracheal intubation in morbidly obese patients. The D-MAC will enable superior view of the glottic structures as well as easier endotracheal intubations than the C-MAC blade. This is the first study to investigate the individual and comparative performances of C-MAC and D-MAC in this patient cohort.


Condition Intervention Phase
Obesity
Device: DMAC
Device: CMAC
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Storz C-MAC and D-MAC Orotracheal Intubation Systems in Morbidly Obese Patients - A Prospective Randomized Crossover Trial

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: 90 seconds ] [ Designated as safety issue: No ]
    Time taken for successful placement of endotracheal tube after a successful laryngoscopy. Typically a successful laryngoscopy will range from few seconds to no more than 90 seconds. A successful intubation will not range more than 90 seconds.


Secondary Outcome Measures:
  • First Laryngoscopy [ Time Frame: 30 seconds ] [ Designated as safety issue: No ]
    Patients underwent laryngoscopy first with their assigned randomized laryngoscope. Time measured was from the time from the moment the anesthesiologist had the laryngoscope in hand to time to optimal visualization of vocal cords.

  • Second Laryngoscopy [ Time Frame: 30 seconds ] [ Designated as safety issue: No ]
    A second laryngoscopy will be performed in patients with the video laryngoscope from the other group. Patients will be intubated after second laryngoscopy with with this same video laryngoscope.


Enrollment: 50
Study Start Date: June 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: D-MAC video laryngoscopy
The Dblade is used to perfom laryngoscopy first but second laryngoscopy and intubation is performed with CMAC blade.
Device: DMAC
The D blade will constitute the experimental treatment and in a cross over fashion will be tested against CMAC blade
Other Name: D-Blade CMAC system
Device: CMAC
The CMAC Blade will constitute the active comparator treatment and in a cross over fashion will be tested against D-blade
Other Name: CMAC blade
Active Comparator: C-MAC video laryngoscopy
The CMAC blade is used to perfom laryngoscopy first but second laryngoscopy and intubation is performed with D-blade
Device: DMAC
The D blade will constitute the experimental treatment and in a cross over fashion will be tested against CMAC blade
Other Name: D-Blade CMAC system
Device: CMAC
The CMAC Blade will constitute the active comparator treatment and in a cross over fashion will be tested against D-blade
Other Name: CMAC blade

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18-65 years
  • ASA I-III
  • BMI ≥ 40 kg/m2

Exclusion Criteria:

  • Necessary awake intubation
  • Mallampati IV
  • < 2 finger breath or 4 cm mouth opening
  • Previous history of difficult intubation
  • ASA IV-V
  • Unstable cervical, thoracic and/or lumbar fracture
  • Known history of congestive heart failure or a severe disease that alters pulmonary mechanics (e.g. chronic obstructive pulmonary disease, restrictive lung diseases)
  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: NCT01556061

Locations
United States, Texas
Memorial Hermann Hospital-TMC
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 at Houston Medical School
  More Information

No publications provided

Responsible Party: Davide Cattano, Associate Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01556061     History of Changes
Other Study ID Numbers: HSC-MS-10-0573
Study First Received: March 1, 2012
Results First Received: July 27, 2013
Last Updated: April 25, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center, Houston:
Laryngoscopy
Airway Management
Intubation

ClinicalTrials.gov processed this record on September 22, 2014