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

Unexpected Difficult Airway Clinical Trial

Official title:

Evaluation of the C-MAC Video Laryngoscope After Failed Direct Laryngoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01122433
• Other study ID #: PN-201005
• Status: Completed
• Phase: N/A
• First received: May 5, 2010
• Last updated: September 27, 2010
• Start date: April 2010
• Est. completion date: September 2010

Study information

• Verified date: September 2010
• Source: Johannes Gutenberg University Mainz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

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technique of video laryngoscopy, the alignment of the oral and pharyngeal axis to facilitate endotracheal intubation is obsolete.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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Unexpected difficult airway

Exclusion Criteria:

• History of difficult or impossible mask ventilation

• Age < 18 years

• ASA grade > 3

• Emergency surgery

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Unexpected Difficult Airway

Intervention

Device:
• Endotracheal intubation using the C-MAC video laryngoscope
Using the C-MAC video laryngoscope for endotracheal intubation after failed direct laryngoscopy

Locations

Country	Name	City	State
Germany	Univeritätsmedizin of the JG University, Department of Anaesthesiology	Mainz

Sponsors (1)

Lead Sponsor	Collaborator
Johannes Gutenberg University Mainz

Country where clinical trial is conducted

Germany, 

Outcome

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