- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01122433
Airway Management Study to Evaluate the C-MAC Video Laryngoscope as an Alternative to the Direct Laryngoscopy
September 27, 2010 updated by: Johannes Gutenberg University Mainz
Evaluation of the C-MAC Video Laryngoscope After Failed Direct Laryngoscopy
The purpose of this study is to evaluate the C-MAC video laryngoscope in difficult airway situations.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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technique of video laryngoscopy, the alignment of the oral and pharyngeal axis to facilitate endotracheal intubation is obsolete.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 Type
Interventional
Enrollment (Anticipated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Mainz, Germany, 55131
- Univeritätsmedizin of the JG University, Department of Anaesthesiology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Unexpected difficult airway
Exclusion Criteria:
- History of difficult or impossible mask ventilation
- Age < 18 years
- ASA grade > 3
- Emergency surgery
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
Using the C-MAC video laryngoscope for endotracheal intubation after failed direct laryngoscopy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
---|---|
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
Outcome Measure |
Measure Description |
---|---|
- 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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Tim Piepho, MD, Department of Anaesthesiology, Universitätsmedizin Mainz
- Principal Investigator: Rüdiger R Noppens, MD, Department of Anaesthesiology, Universitätsmedizin Mainz
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2010
Primary Completion (Actual)
September 1, 2010
Study Completion (Actual)
September 1, 2010
Study Registration Dates
First Submitted
May 5, 2010
First Submitted That Met QC Criteria
May 12, 2010
First Posted (Estimate)
May 13, 2010
Study Record Updates
Last Update Posted (Estimate)
September 28, 2010
Last Update Submitted That Met QC Criteria
September 27, 2010
Last Verified
September 1, 2010
More Information
Terms related to this study
Other Study ID Numbers
- PN-201005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Unexpected Difficult Airway
-
Derince Training and Research HospitalCompletedDifficult Intubation | Difficult AirwayTurkey
-
Lazarski UniversityCompletedIntubation; Difficult or Failed | Difficult Airway | Intubation;DifficultPoland
-
Michael MaRecruitingDifficult Intubation | Difficult Airway IntubationIreland
-
Cairo UniversityCompleted
-
Brno University HospitalCompleted
-
University of DebrecenUniversity of Zurich; Iuliu Hatieganu University of Medicine and PharmacyCompleted
-
University College Hospital GalwayTerminatedDifficult Intubation | Airway | Airway DeviceIreland
-
Peking University Third HospitalRecruiting
-
Istanbul UniversityRecruitingDifficult AirwayTurkey
-
Tongji HospitalCompleted
Clinical Trials on Endotracheal intubation using the C-MAC video laryngoscope
-
International Institute of Rescue Research and...CompletedIntubation | Cardiopulmonary Resuscitation
-
Children's Hospital of PhiladelphiaEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedIntubation Complication | Intubation;Difficult | Failed or Difficult Intubation, SequelaUnited States, Canada, Singapore
-
Hopital FochCompleted
-
Aga Khan UniversityUnknown
-
Insel Gruppe AG, University Hospital BernThe Hospital for Sick Children; Children's Hospital of Philadelphia; Charite... and other collaboratorsRecruitingAirway ManagementSwitzerland, Canada, Germany
-
Loma Linda UniversityCompletedEndotracheal IntubationUnited States
-
Sisli Hamidiye Etfal Training and Research HospitalCompletedPediatrics | Anesthesiology
-
Seoul National University HospitalUnknownCervical Spinal Cord Injury | Intubation;Difficult
-
Alexandria UniversityUnknownSingle Lung Ventilation | Thoracic AnesthesiaEgypt
-
Hanyang UniversityCompleted