Tracheal IntubationNCT01210105
Ice-pick Intubation With Video Laryngoscopes in a Manikin With Restricted Access to the Airway
An observational study of Tracheal Intubation, run by University of Cologne at 1 site in Germany.
Trial summary
To determine whether video laryngioscopes facilitate intubation in ice-pick position in a manikin with restricted access to the airway Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tracheal Intubation
- How many people
- 25 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2010to Dec 2010
- Phase
- Observational
- 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 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: anaesthesiologists
Who may be able to join
- anaesthesiologists
- experienced in airway management
- experienced in emergency medicine
Who cannot join
- no experience in airway management
- missing infiormed consent
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anaesthesiology and Postoperative Critical Care
Cologne, 50937
About this study
Official title: Comparison of Different Video Laryngoscopes in Ice-pick Position in an Manikin With Restricted Access to the Airway
To determine whether video laryngioscopes facilitate intubation in ice-pick position in a manikin with restricted access to the airway
Read the detailed description
To determine whether video laryngioscopes facilitate intubation in ice-pick position (also called inverse intubation) in a manikin with restricted access to the airway
- Conditions
- Tracheal Intubation
- Keywords
- intubation, video laryngoscopes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Macintosh #3 Laryngoscope | Not described | |
| Glidescope | Not described | |
| Ambu Pentax AWS | Not described | |
| McGrath | Not described | |
| Airtraq | Not described | |
| Storz C-MAC | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
tracheal intubation
Measured: max 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionNov 2010
- Study completionDec 2010
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 Tracheal IntubationStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, J. Hinkelbein, University of Cologne
- Investigators
- Wolfgang A Wetsch, MD, Principal investigator, Department of Anaesthesiology, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01210105
- Sponsor's protocol ID
- 10-182-3
- Status last verified
- Sep 2011
- First submitted
- 27 Sep 2010
- Last updated
- 22 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Wetsch WA, Hellmich M, Spelten O, Schier R, Bottiger BW, Hinkelbein J. Tracheal intubation in the ice-pick position with video laryngoscopes: a randomised controlled trial in a manikin. Eur J Anaesthesiol. 2013 Sep;30(9):537-43. doi: 10.1097/EJA.0b013e3283614119.
PubMed 23736089
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different Video Laryngoscopes in Ice-pick Position in an Manikin With Restricted Access to the Airway
- ClinicalTrials.gov ID
- NCT01210105
- Acronym / sponsor ID
- 10-182-3
- Conditions
- Tracheal Intubation
- Keywords
- intubation, video laryngoscopes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 28 Sep 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.
To determine whether video laryngioscopes facilitate intubation in ice-pick position in a manikin with restricted access to the airway
Detailed description
To determine whether video laryngioscopes facilitate intubation in ice-pick position (also called inverse intubation) in a manikin with restricted access to the airway
Study design
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Macintosh #3 Laryngoscope | – | – |
| Glidescope | – | – |
| Ambu Pentax AWS | – | – |
| McGrath | – | – |
| Airtraq | – | – |
| Storz C-MAC | – | – |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- anaesthesiologists
Key inclusion criteria (3 listed)
- anaesthesiologists
- experienced in airway management
- experienced in emergency medicine
Key exclusion criteria (2 listed)
- no experience in airway management
- missing infiormed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
tracheal intubation
Time frame: max 5 minutes
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 22 Sep 2011.
- Derived from this study: PubMed 23736089Wetsch WA, Hellmich M, Spelten O, Schier R, Bottiger BW, Hinkelbein J. Tracheal intubation in the ice-pick position with video laryngoscopes: a randomised controlled trial in a manikin. Eur J Anaesthesiol. 2013 Sep;30(9):537-43. doi: 10.1097/EJA.0b013e3283614119.
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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.
Wolfgang A Wetsch, MD principal investigator
Department of Anaesthesiology, University of Cologne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tracheal Intubation, run by University of Cologne 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 3 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 22 Sep 2011. 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?
tracheal intubation (time frame: max 5 minutes). 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 NCT01210105, 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 22 Sep 2011.