Intubation IntratrachealNCT01635660
Out-of-Hospital Randomized Comparison of Video-assisted Endotracheal Intubation
A study testing Intubation in people with Intubation Intratracheal and Airway Management, run by University Hospital Schleswig-Holstein at 3 sites in Germany.
Trial summary
This research project examines the effectiveness of different video laryngoscopes in a out-of-hospital emergency intubation. Since in preclinical airway management severe incidents with esophageal failures of intubation may partly happen or rather endotracheal Intubation may completely fail, it is of great importance… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intubation Intratracheal, Airway Management, Emergency Treatment
- What is being tested?
- Intubation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 3 sitesGermany
- Study dates
- Oct 2011to Jun 2015
- 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
- All adult emergency patients, age 18 years and older for whom a preclinical emergency intubation is necessary
Who cannot join
- Age under 18 years
- Laryngoscopy according to the algorithm of airway management not being indicated
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Klinikum LDW / NEF Bremen Süd
Bremen
Uniklinikum Greifswald / DRF Luftrettung
Greifswald
Uniklinikum Kiel / DRF Luftrettung
Rendsburg, 24768
About this study
Official title: Prospective, Randomized, Multicentre Evaluation of Different Video-assisted, for Emergency Use Designed Intubation Aids for Out-of-hospital Endotracheal Intubation. Comparison of C-MAC System PM (Karl Storz), AP Advance (Venner Medical), and King Vision (King Systems) at Four German HEMS.
This research project examines the effectiveness of different video laryngoscopes in a out-of-hospital emergency intubation. Since in preclinical airway management severe incidents with esophageal failures of intubation may partly happen or rather endotracheal Intubation may completely fail, it is of great importance to evaluate alternative ways of endotracheal intubation in out-of-hospital emergency medicine. Video laryngoscopy has been proven in everyday clinical practice and may clinically be superior in most situations when compared to endotracheal Intubation using a conventional laryngoscope. No data exist, if different video laryngoscope types perform differently in the out-of-hospital setting. The investigators hypothesize that there would be no difference with regard to intubation time, intubation success, and intubation morbidity between different models of video laryngoscopes.
- Being tested
- Intubation
- Keywords
- Out-of-hospital, airway management, intubation, video laryngoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IntubationDevice
Tracheal Intubation with the assigned video laryngoscope
| Study group | Role | What they receive |
|---|---|---|
| C-MAC System | Active comparator | Not described Receives: Device: Intubation |
| AP Advance | Active comparator | Not described Receives: Device: Intubation |
| King Vision | Active comparator | Not described Receives: Device: Intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation success
Measured: Immediately after intubation
Secondary outcomes (2)
Intubation on first attempt
Measured: Immediately after intubation
Intubation time
Measured: Immediately after intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2012 (estimated)
- Study startOct 2011
- Primary completionJul 2014
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intubation IntratrachealStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Collaborators
- Karl Storz Endoscopy, Germany, King Systems Corporation, LMA, Germany, Venner Medical, Germany
- Responsible party
- Principal investigator, Erol Cavus, University Hospital Schleswig-Holstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01635660
- Sponsor's protocol ID
- ANKIEL-VLS-2012-CAV
- Status last verified
- Aug 2015
- First submitted
- 4 Jul 2012
- Last updated
- 4 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Cavus E, Janssen S, Reifferscheid F, Caliebe A, Callies A, von der Heyden M, Knacke PG, Doerges V. Videolaryngoscopy for Physician-Based, Prehospital Emergency Intubation: A Prospective, Randomized, Multicenter Comparison of Different Blade Types Using A.P. Advance, C-MAC System, and KingVision. Anesth Analg. 2018 May;126(5):1565-1574. doi: 10.1213/ANE.0000000000002735.
PubMed 29239965
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Multicentre Evaluation of Different Video-assisted, for Emergency Use Designed Intubation Aids for Out-of-hospital Endotracheal Intubation. Comparison of C-MAC System PM (Karl Storz), AP Advance (Venner Medical), and King Vision (King Systems) at Four German HEMS.
- ClinicalTrials.gov ID
- NCT01635660
- Acronym / sponsor ID
- ANKIEL-VLS-2012-CAV
- Keywords
- Out-of-hospital, airway management, intubation, video laryngoscope
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Collaborators
- Karl Storz Endoscopy, Germany, King Systems Corporation, LMA, Germany, Venner Medical, Germany
- Study start
- Oct 2011
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 9 Jul 2012 (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.
This research project examines the effectiveness of different video laryngoscopes in a out-of-hospital emergency intubation. Since in preclinical airway management severe incidents with esophageal failures of intubation may partly happen or rather endotracheal Intubation may completely fail, it is of great importance to evaluate alternative ways of endotracheal intubation in out-of-hospital emergency medicine. Video laryngoscopy has been proven in everyday clinical practice and may clinically be superior in most situations when compared to endotracheal Intubation using a conventional laryngoscope. No data exist, if different video laryngoscope types perform differently in the out-of-hospital setting. The investigators hypothesize that there would be no difference with regard to intubation time, intubation success, and intubation morbidity between different models of video laryngoscopes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| C-MAC System | Active comparator | Device: Intubation |
| AP Advance | Active comparator | Device: Intubation |
| King Vision | Active comparator | Device: Intubation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adult emergency patients, age 18 years and older for whom a preclinical emergency intubation is necessary
Key exclusion criteria (2 listed)
- Age under 18 years
- Laryngoscopy according to the algorithm of airway management not being indicated
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 |
|---|---|---|
| IntubationTracheal Intubation with the assigned video laryngoscope | Device | AP Advance, C-MAC System, King Vision |
Primary outcome
Intubation success
Time frame: Immediately after intubation
2 secondary outcomes
Intubation on first attempt
Time frame: Immediately after intubation
Intubation time
Time frame: Immediately after intubation
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 4 Aug 2015.
- Derived from this study: PubMed 29239965Cavus E, Janssen S, Reifferscheid F, Caliebe A, Callies A, von der Heyden M, Knacke PG, Doerges V. Videolaryngoscopy for Physician-Based, Prehospital Emergency Intubation: A Prospective, Randomized, Multicenter Comparison of Different Blade Types Using A.P. Advance, C-MAC System, and KingVision. Anesth Analg. 2018 May;126(5):1565-1574. doi: 10.1213/ANE.0000000000002735.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intubation in people with Intubation Intratracheal and Airway Management, run by University Hospital Schleswig-Holstein at 3 sites 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 2 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 4 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Intubation success (time frame: Immediately after intubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01635660, which also lists 1 linked publication.
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 4 Aug 2015; AzTrials last refreshed its copy on 8 Nov 2026.