Phase 4
N=50
Comparison of Storz C-MAC and D-MAC Orotracheal Intubation Systems in Morbidly Obese Patients
Obesity
Bottom Line
View on ClinicalTrials.gov: NCT01556061 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
May 2014
Primary outcome: Primary: Time for Intubation — 9; 7.3 seconds
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- DMAC (Device); CMAC (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center, Houston
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time for Intubation |
9; 7.3 | — |
| SECONDARY First Laryngoscopy |
6.7; 7.2 | — |
| SECONDARY Second Laryngoscopy |
6.7; 5.5 | — |
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.
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT01556061). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.