Airway Management Study to Evaluate the C-MAC Video Laryngoscope as an Alternative to the Direct Laryngoscopy

Not Applicable

Completed

• Conditions: Unexpected Difficult Airway
• Interventions: Device: Endotracheal intubation using the C-MAC video laryngoscope

• Registration Number: NCT01122433
• Lead Sponsor: Johannes Gutenberg University Mainz

Brief Summary

The purpose of this study is to evaluate the C-MAC video laryngoscope in difficult airway situations.

Detailed Description

Unanticipated difficulties during tracheal intubation and failure to intubate are among the leading causes of anaesthesia related morbidity and mortality. Using the technique of video laryngoscopy, the alignment of the oral and pharyngeal axis to facilitate endotracheal intubation is obsolete. In this study we evaluate the C-MAC video laryngoscope (STORZ, Tuttlingen, Germany) for endotracheal intubation in difficult intubation situations (Cormack \& Lehane (CL) grade 3 and 4) validated by Macintosh laryngoscope. We hypothesize that endotracheal intubation is possible using the C-MAC in patients after failed direct laryngoscopy. We also examine whether visualisation of the glottis is improved with this device compared to direct laryngoscopy and possible complications such as soft tissue injury.

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-05-05
• Study First Submitted QC: 2010-05-12
• Study First Posted: 2010-05-13
• Status Verified: 2010-09
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Last Update Submitted: 2010-09-27
• Last Update Posted: 2010-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Unexpected difficult airway

Exclusion Criteria

• History of difficult or impossible mask ventilation
• Age < 18 years
• ASA grade > 3
• Emergency surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
C-MAC	Endotracheal intubation using the C-MAC video laryngoscope	After a maximum of three failed intubation attempts using direct laryngoscope the C-MAC video laryngoscope is used as an emergency airway device.

Primary Outcome Measures

Name	Time	Method
Success rate of endotracheal intubation using the C-MAC video laryngoscope		The investigators evaluate the C-MAC as an alternative after failed direct laryngoscopy. Primary outcome measure is the success rate using the C-MAC video laryngoscope in unexpected difficult airways.

Secondary Outcome Measures

Name	Time	Method
- improved glottic view		According to the Cormacl-Lehane classification the improved glottis view using the C-MAC is documented.
- complications		Possible complications are supra glottic trauma, tooth damage, soft tissure bleeding,...
- numbers of intubation attempts		Necessary intubation attempts using the C-MAC video laryngoscope to secutre the airway.
- size of blade (C-MAC)		Different blades are available for the C-MAC. We evaluate with which blade securing the airway was possible.

Trial Locations

Locations (1)

Univeritätsmedizin of the JG University, Department of Anaesthesiology; 🇩🇪 Mainz, Germany