Tracheal IntubationNCT00847184
Comparison of Airtraq Versus MacIntosh Intubation Via Nasal Approach
A study testing Intubation and Airtraq in people with Tracheal Intubation, run by Kliniken Essen-Mitte at 1 site in Germany.
Trial summary
Time, success rate, and number of optimising maneuvers for tracheal intubation via the nasal approach are not different when Aitraq technique is used compared to a standard MacIntosh blade. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tracheal Intubation
- What is being tested?
- Intubation and Airtraq
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2009to Nov 2009
- 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
- Scheduled for nasal intubation
- Adult
Who cannot join
- Age under 18 years
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Prof. Dr. Harald Groeben
Essen, 45136
Harald Groeben, M.D., ##49 201 174 31109, h.groeben@kliniken-essen-mitte.de
Harald Groeben, M.D.
About this study
Official title: Comparison of Airtraq vs. MacIntosh Intubation Via Nasal Approach
Time, success rate, and number of optimising maneuvers for tracheal intubation via the nasal approach are not different when Aitraq technique is used compared to a standard MacIntosh blade.
Read the detailed description
One hundred adult patients with an expected easy intubation and 100 patients with an expected difficult intubation are enrolled. Intubations are performed by two experienced fully boarded anesthesiologists. The design of the study is prospective and randomised.
- Conditions
- Tracheal Intubation
- Being tested
- Intubation, Airtraq
- Keywords
- nasal intubation, Aitraq, difficult intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IntubationDevice
Intubation using the standard MacIntosh blade
AirtraqDevice
Also called Aitraq, Prodol Meditec S.A., Vizcaya, Spain
Intubation with the use of the Airtraq technique
| Study group | Role | What they receive |
|---|---|---|
| 1. Airtraq | Active comparator | Intubation with the use of the Airtraq technique Receives: Device: Airtraq |
| 2. MacIntosh | Active comparator | Intubation using the standard MacIntosh blade Receives: Device: Intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time for intubation
Measured: 10 month
Secondary outcomes (1)
Success rate for intubation
Measured: 10 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionNov 2009 (estimated)
- Study completionNov 2009 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kliniken Essen-Mitte
- Sponsor type
- University, hospital or other
- Investigators
- Harald Groeben, M.D., Principal investigator, Kliniken Essen-Mitte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00847184
- Sponsor's protocol ID
- Airtraqnasal2009
- Status last verified
- Feb 2009
- First submitted
- 11 Feb 2009
- Last updated
- 19 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Maharaj CH, Higgins BD, Harte BH, Laffey JG. Evaluation of intubation using the Airtraq or Macintosh laryngoscope by anaesthetists in easy and simulated difficult laryngoscopy--a manikin study. Anaesthesia. 2006 May;61(5):469-77. doi: 10.1111/j.1365-2044.2006.04547.x.
PubMed 16674623
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Airtraq vs. MacIntosh Intubation Via Nasal Approach
- ClinicalTrials.gov ID
- NCT00847184
- Acronym / sponsor ID
- Airtraqnasal2009
- Conditions
- Tracheal Intubation
- Keywords
- nasal intubation, Aitraq, difficult intubation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Kliniken Essen-MitteUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Nov 2009 (estimated)
- Study completion
- Nov 2009 (estimated)
- First posted
- 19 Feb 2009 (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.
Time, success rate, and number of optimising maneuvers for tracheal intubation via the nasal approach are not different when Aitraq technique is used compared to a standard MacIntosh blade.
Detailed description
One hundred adult patients with an expected easy intubation and 100 patients with an expected difficult intubation are enrolled. Intubations are performed by two experienced fully boarded anesthesiologists. The design of the study is prospective and randomised.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. Airtraq | Active comparator | Device: AirtraqIntubation with the use of the Airtraq technique |
| 2. MacIntosh | Active comparator | Device: IntubationIntubation using the standard MacIntosh blade |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Scheduled for nasal intubation
- Adult
Key exclusion criteria (1 listed)
- Age under 18 years
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 |
|---|---|---|
| IntubationIntubation using the standard MacIntosh blade | Device | 2. MacIntosh |
| AirtraqAlso: Aitraq, Prodol Meditec S.A., Vizcaya, SpainIntubation with the use of the Airtraq technique | Device | 1. Airtraq |
Primary outcome
Time for intubation
Time frame: 10 month
1 secondary outcome
Success rate for intubation
Time frame: 10 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2009.
- Background: PubMed 16674623Maharaj CH, Higgins BD, Harte BH, Laffey JG. Evaluation of intubation using the Airtraq or Macintosh laryngoscope by anaesthetists in easy and simulated difficult laryngoscopy--a manikin study. Anaesthesia. 2006 May;61(5):469-77. doi: 10.1111/j.1365-2044.2006.04547.x.
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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.
Harald Groeben, M.D. principal investigator
Kliniken Essen-Mitte
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intubation and Airtraq in people with Tracheal Intubation, run by Kliniken Essen-Mitte 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 19 Feb 2009. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time for intubation (time frame: 10 month). 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 NCT00847184, 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 19 Feb 2009.