Intubation, IntratrachealPhase 4NCT00910156
Indirect Laryngoscopy for Nasal Intubation
A Phase 4 study testing Airtraq laryngoscope, Glidescope laryngoscope and Macintosh laryngoscope in people with Intubation, Intratracheal, run by General Hospital Linz at 1 site in Austria.
Trial summary
Comparison of ease and convenience of nasotracheal intubation with the use of the two indirect laryngoscopes, Airtraq or Glidescope, versus the traditionally used Macintosh laryngoscope. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intubation, Intratracheal
- What is being tested?
- Airtraq laryngoscope, Glidescope laryngoscope and Macintosh laryngoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteAustria
- Study dates
- Start not givento not given
- Phase
- Phase 4
- 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 to 80 years
- All sexes
- Adult, Older adult
Who may be able to join
- nasotracheal intubation
Who cannot join
- anticipated difficult airway
- risk factors for gastric aspiration
- history of bleeding
- relevant allergy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Indirect Versus Direct Laryngoscopy for Routine Nasotracheal Intubation: a Pilot Study
Comparison of ease and convenience of nasotracheal intubation with the use of the two indirect laryngoscopes, Airtraq or Glidescope, versus the traditionally used Macintosh laryngoscope.
- Conditions
- Intubation, Intratracheal
- Being tested
- Airtraq laryngoscope, Glidescope laryngoscope, Macintosh laryngoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Airtraq laryngoscopeDevice
Airtraq intubation
Glidescope laryngoscopeDevice
glidescope intubation
Macintosh laryngoscopeDevice
Macintosh intubation
| Study group | Role | What they receive |
|---|---|---|
| Airtraq | Active comparator | Not described Receives: Device: Airtraq laryngoscope |
| Glidescope | Active comparator | Not described Receives: Device: Glidescope laryngoscope |
| Macintosh | Active comparator | Not described Receives: Device: Macintosh laryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation Difficulty Scale (IDS)
Secondary outcomes (1)
Posture of the intubator
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
Sponsor and investigators
- Lead sponsor
- General Hospital Linz
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00910156
- Sponsor's protocol ID
- P01
- Status last verified
- May 2009
- First submitted
- 28 May 2009
- Last updated
- 29 May 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indirect Versus Direct Laryngoscopy for Routine Nasotracheal Intubation: a Pilot Study
- ClinicalTrials.gov ID
- NCT00910156
- Acronym / sponsor ID
- P01
- Conditions
- Intubation, Intratracheal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- General Hospital LinzUniversity, hospital or other
- First posted
- 29 May 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.
Comparison of ease and convenience of nasotracheal intubation with the use of the two indirect laryngoscopes, Airtraq or Glidescope, versus the traditionally used Macintosh laryngoscope.
Study design
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Airtraq | Active comparator | Device: Airtraq laryngoscope |
| Glidescope | Active comparator | Device: Glidescope laryngoscope |
| Macintosh | Active comparator | Device: Macintosh laryngoscope |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- nasotracheal intubation
Key exclusion criteria (4 listed)
- anticipated difficult airway
- risk factors for gastric aspiration
- history of bleeding
- relevant allergy
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 |
|---|---|---|
| Airtraq laryngoscopeAirtraq intubation | Device | Airtraq |
| Glidescope laryngoscopeglidescope intubation | Device | Glidescope |
| Macintosh laryngoscopeMacintosh intubation | Device | Macintosh |
Primary outcome
Intubation Difficulty Scale (IDS)
1 secondary outcome
Posture of the intubator
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 29 May 2009.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Airtraq laryngoscope, Glidescope laryngoscope and Macintosh laryngoscope in people with Intubation, Intratracheal, run by General Hospital Linz at 1 site in Austria.
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 29 May 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 Austria. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Difficulty Scale (IDS). 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 29 May 2009.