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

NCT ID: NCT01122433

Last Updated: 2010-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2010-09-30

Brief Summary

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

Detailed Description

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technique of video laryngoscopy, the alignment of the oral and pharyngeal axis to facilitate endotracheal intubation is obsolete.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

Conditions

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Unexpected Difficult Airway

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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C-MAC

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

Group Type EXPERIMENTAL

Endotracheal intubation using the C-MAC video laryngoscope

Intervention Type DEVICE

Using the C-MAC video laryngoscope for endotracheal intubation after failed direct laryngoscopy

Interventions

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Endotracheal intubation using the C-MAC video laryngoscope

Using the C-MAC video laryngoscope for endotracheal intubation after failed direct laryngoscopy

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Unexpected difficult airway

Exclusion Criteria

* History of difficult or impossible mask ventilation
* Age \< 18 years
* ASA grade \> 3
* Emergency surgery
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johannes Gutenberg University Mainz

OTHER

Sponsor Role lead

Responsible Party

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Universitätsmedizin of the JG University

Principal Investigators

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Tim Piepho, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Anaesthesiology, Universitätsmedizin Mainz

Rüdiger R Noppens, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Anaesthesiology, Universitätsmedizin Mainz

Locations

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Univeritätsmedizin of the JG University, Department of Anaesthesiology

Mainz, , Germany

Site Status

Countries

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Germany

Other Identifiers

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PN-201005

Identifier Type: -

Identifier Source: org_study_id