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: March 16, 2012
Last verified: March 2012
  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
Difficult Intubation
Device: D-MAC video laryngoscope (Intubation)
Device: C-MAC video laryngoscope (Intubation)
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:
  • Ease of use of laryngoscope [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
    Ease of use will be evaluated during time for placement of endotracheal tube, meaning the time taken for induction of anesthesia, laryngoscopy and endotracheal intubation, averagely 15-30 seconds up to 3 minutes, plus monitoring of hemodynamic variables.

  • Occurences/events during intubation [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Time-to-Event Outcome Measures from airway assessment to discharge from PACU. Occurrence will be defined as evidence of fogging, bleeding, trauma during laryngoscopy/ intubation; changes in heart rate and blood pressure during and immediately after laryngoscopy/intubation. The time frame to collect these outcomes will be the time from induction of anesthesia to completion of intubation. Patients will be assessed from the time of airway assessment to the time of discharge from PACU (averagely a minimum of 6-12 hours).


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 Device: D-MAC video laryngoscope (Intubation)
Patients assigned to this arm will have a first laryngoscopy with D-MAC video laryngoscope then a second laryngoscopy with the C-MAC video laryngoscope. Patients will be intubated after second laryngoscopy with C-MAC laryngoscope.
Other Name: D-MAC video laryngoscopy
Placebo Comparator: C-MAC video laryngoscopy Device: C-MAC video laryngoscope (Intubation)
Patients assigned to this arm will have a first laryngoscopy with C-MAC video laryngoscope then a second laryngoscopy with the D-MAC video laryngoscope. Patients will be intubated after second laryngoscopy with D-MAC laryngoscope.
Other Name: D-MAC video laryngoscopy

  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
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
Last Updated: March 16, 2012
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 April 17, 2014