Unexpected Difficult AirwayNCT01122433
Airway Management Study to Evaluate the C-MAC Video Laryngoscope as an Alternative to the Direct Laryngoscopy
A study testing Endotracheal intubation using the C-MAC video laryngoscope in people with Unexpected Difficult Airway, run by Johannes Gutenberg University Mainz at 1 site in Germany.
Trial summary
The purpose of this study is to evaluate the C-MAC video laryngoscope in difficult airway situations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unexpected Difficult Airway
- What is being tested?
- Endotracheal intubation using the C-MAC video laryngoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2010to Sep 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unexpected difficult airway
Who cannot join
- History of difficult or impossible mask ventilation
- Age < 18 years
- ASA grade > 3
- Emergency surgery
Trial locations and contacts
1 site in 1 country.
Germany1 site
Univeritätsmedizin of the JG University, Department of Anaesthesiology
Mainz, 55131
About this study
Official title: 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.
Read the 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technique of video laryngoscopy, the alignment of the oral and pharyngeal axis to facilitate endotracheal intubation is obsolete.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.
- Conditions
- Unexpected Difficult Airway
- Being tested
- Endotracheal intubation using the C-MAC video laryngoscope
- Keywords
- difficult airway, indirect laryngoscopy, C-MAC video laryngoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endotracheal intubation using the C-MAC video laryngoscopeDevice
Using the C-MAC video laryngoscope for endotracheal intubation after failed direct laryngoscopy
| Study group | Role | What they receive |
|---|---|---|
| C-MAC | Experimental | After a maximum of three failed intubation attempts using direct laryngoscope the C-MAC video laryngoscope is used as an emergency airway device. Receives: Device: Endotracheal intubation using the C-MAC video laryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (4)
- 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2010 (estimated)
- Study startApr 2010
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unexpected Difficult AirwayStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Investigators
- Tim Piepho, MD, Principal investigator, Department of Anaesthesiology, Universitätsmedizin MainzRüdiger R Noppens, MD, Principal investigator, Department of Anaesthesiology, Universitätsmedizin Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01122433
- Sponsor's protocol ID
- PN-201005
- Status last verified
- Sep 2010
- First submitted
- 5 May 2010
- Last updated
- 28 Sep 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the C-MAC Video Laryngoscope After Failed Direct Laryngoscopy
- ClinicalTrials.gov ID
- NCT01122433
- Acronym / sponsor ID
- PN-201005
- Conditions
- Unexpected Difficult Airway
- Keywords
- difficult airway, indirect laryngoscopy, C-MAC video laryngoscope
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 13 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| C-MAC | Experimental | Device: Endotracheal intubation using the C-MAC video laryngoscopeAfter a maximum of three failed intubation attempts using direct laryngoscope the C-MAC video laryngoscope is used as an emergency airway device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Unexpected difficult airway
Key exclusion criteria (4 listed)
- History of difficult or impossible mask ventilation
- Age < 18 years
- ASA grade > 3
- Emergency surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endotracheal intubation using the C-MAC video laryngoscopeUsing the C-MAC video laryngoscope for endotracheal intubation after failed direct laryngoscopy | Device | C-MAC |
Primary outcome
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.
4 secondary outcomes
- improved glottic view
- complications
- numbers of intubation attempts
- size of blade (C-MAC)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2010.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tim Piepho, MD principal investigator
Department of Anaesthesiology, Universitätsmedizin Mainz
Rüdiger R Noppens, MD principal investigator
Department of Anaesthesiology, Universitätsmedizin Mainz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endotracheal intubation using the C-MAC video laryngoscope in people with Unexpected Difficult Airway, run by Johannes Gutenberg University Mainz at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of endotracheal intubation using the C-MAC video laryngoscope. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2010.