N/A
N=50
Initial Experience With Storz C-MAC Video Intubation System
Intubation; Difficult
Bottom Line
View on ClinicalTrials.gov: NCT01104090 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcome: Primary: Time for Intubation — 12.3; 9.8 seconds
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- C-MAC direct laryngoscopy (Device); C-MAC Indirect laryngoscopy (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center, Houston
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time for Intubation |
12.3; 9.8 | — |
| SECONDARY Laryngoscopy Time |
8.7; 14.1; 9.1; 12.2 | — |
| SECONDARY Airway View at the Time of Laryngoscopy as Categorized by the Modified Cormack-Lehane Classification (Before External Manipulation) |
12; 19; 7; 3; 6; 1 | — |
| SECONDARY Airway View at the Time of Laryngoscopy as Categorized by the Modified Cormack-Lehane Classification (After External Manipulation) |
15; 20; 10; 4; 0; 1 | — |
| SECONDARY Number of Participants With Successful Intubation |
25; 25 | — |
| SECONDARY Ease of Intubation as Assessed by a Rating Scale |
14; 16; 6; 4; 4; 4 | — |
| SECONDARY Ease of Laryngoscopy as Assessed by a Rating Scale |
15; 13; 5; 4; 4; 5 | — |
Summary
The purpose of this study is to determine the safety and efficacy of the C-MAC (Karl Storz Endoscopy, Inc., Tuttlingen, Germany) video intubation system guided intubation techniques.
We hypothesize that the C-MAC video laryngoscope is safe and efficacious in terms of successful endotracheal intubation. The C-MAC may be a safe and suitable alternative device for routine and difficult laryngoscopy and tracheal intubation. This is the first study to investigate the performance of C-MAC in clinical practice.
Eligibility Criteria
Inclusion Criteria
- Age 18 - 80 years of age
- ASA I - III
- Mallampati I-III
- Mouthopening > 4cm
Exclusion Criteria
- Age 80 years of age
- ASA IV - V
- Mallampati IV - V
- Mouthopening < 4cm
Data sourced from ClinicalTrials.gov (NCT01104090). 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.