Comparison of Storz C-MAC and D-MAC Orotracheal Intubation Systems in Morbidly Obese Patients
This study has been completed.
Sponsor:
The University of Texas Health Science Center, Houston
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
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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 May 23, 2013