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

NCT01556061 | Completed Phase 4 Results DMC

• 1 other identifier: HSC-MS-10-0573
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity

Keywords

Laryngoscopy; Airway Management; Intubation

Outcome Measures

Primary Outcomes (1)

• Time for Intubation

  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.

  90 seconds

Secondary Outcomes (2)

• First Laryngoscopy

  30 seconds

• Second Laryngoscopy

  30 seconds

Study Arms (2)

D-MAC video laryngoscopy

EXPERIMENTAL

The Dblade is used to perfom laryngoscopy first but second laryngoscopy and intubation is performed with CMAC blade.

Device: DMAC; Device: CMAC

C-MAC video laryngoscopy

ACTIVE COMPARATOR

The CMAC blade is used to perfom laryngoscopy first but second laryngoscopy and intubation is performed with D-blade

Device: DMAC; Device: CMAC

Interventions

DMAC DEVICE

The D blade will constitute the experimental treatment and in a cross over fashion will be tested against CMAC blade

Also known as: D-Blade CMAC system

C-MAC video laryngoscopy; D-MAC video laryngoscopy

CMAC DEVICE

The CMAC Blade will constitute the active comparator treatment and in a cross over fashion will be tested against D-blade

Also known as: CMAC blade

C-MAC video laryngoscopy; D-MAC video laryngoscopy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

Memorial Hermann Hospital-TMC

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Davide Cattano MD PhD
• Organization: University of Texas at Houston Medical School/ Dept. of Anesthesiology

davide.cattano@uth.tmc.edu

713-500-6235

Study Officials

• Davide Cattano, MD, PhD

  University Of Texas at Houston Medical School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 1, 2012
• First Posted: March 16, 2012
• Study Start: June 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: May 26, 2014
• Results First Posted: May 26, 2014

Record last verified: 2014-04

Locations

US (1)