IntubationPhase 4LaryngotestNCT00876967
Comparison of Three Laryngoscope Blades for Orotracheal Intubation in the Operating Room
A Phase 4 study testing metallic single use blade, plastic single use blade and metallic reusable blade in people with Intubation, run by University Hospital, Caen at 1 site in France.
Trial summary
The purpose of this study is to determinate if there is a difference in performance provided by three laryngoscope blades: plastic single use, metallic single use and metallic reusable blades. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intubation
- What is being tested?
- metallic single use blade, plastic single use blade and metallic reusable blade
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,040 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2008to Feb 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient age over 18 who need general anesthesia with orothracheal intubation
Who cannot join
- patient age under 18 or major assist
- presence of upper airway malformation or abnormality
- cervical or facial trauma
- previous difficult intubation known
- no use of curare
- Body Mass Index over 30kg/m2 if crush induction use
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Performance of Three Laryngoscope Blades: Plastic Single Use, Metallic Single Use and Metallic Reusable Blades.
The purpose of this study is to determinate if there is a difference in performance provided by three laryngoscope blades: plastic single use, metallic single use and metallic reusable blades.
Read the detailed description
Primary outcome: success of intubation at the first attempt
Secondary outcomes: quality of laryngeal exposition (Cormack and Lehanne modify grade), duration to success intubation, Intubation difficult Scale and result of intubation procedure
- Conditions
- Intubation
- Being tested
- metallic single use blade, plastic single use blade, metallic reusable blade
- Keywords
- anesthesiology, randomized, laryngoscope, intubation, laryngeal exposition, laryngoscope blades, plastic single use blade, metallic single use blade, metallic reusable blade, success to intubation at first attempt, Cormack and lehanne modify grade
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metallic single use bladeDevice
metallic single use blade
plastic single use bladeDevice
plastic single use blade
metallic reusable bladeDevice
metallic reusable blade
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | metallic single use blade Receives: Device: metallic single use blade |
| 2 | Experimental | plastic single use blade Receives: Device: plastic single use blade |
| 3 | Active comparator | metallic reusable blade Receives: Device: metallic reusable blade |
What is being measured
The primary outcome is the main question the study is designed to answer.
success of intubation at the first attempt
Measured: immediately
Secondary outcomes (4)
quality of laryngeal exposition (Cormack and Lehanne modify grade)
Measured: immediately
duration to success intubation
Measured: immediately
Intubation difficult Scale
Measured: Immediately
result of intubation procedure
Measured: immediately
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2009 (estimated)
- Study startJan 2008
- Primary completionJan 2010
- Study completionFeb 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 IntubationStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,040 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Investigators
- HANOUZ Jean-Luc, PHD, Study director, Anesthesiology critical care SAMU departement, University Hospital of Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00876967
- Sponsor's protocol ID
- Laryngotest
- Other IDs
- N°ID RCB 2007-A00321-52
- Acronym
- Laryngotest
- Status last verified
- Mar 2010
- First submitted
- 6 Apr 2009
- Last updated
- 31 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Buleon C, Parienti JJ, Lesage A, Grandin W, Pouliquen E, Flais F, Simonet T, Gerard JL, Hanouz JL. Comparison of plastic and metallic single-use and metallic reusable laryngoscope blades: a randomised controlled trial. Eur J Anaesthesiol. 2013 Apr;30(4):163-9. doi: 10.1097/EJA.0b013e32835c1cdb.
PubMed 23274619
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Performance of Three Laryngoscope Blades: Plastic Single Use, Metallic Single Use and Metallic Reusable Blades.
- ClinicalTrials.gov ID
- NCT00876967
- Acronym / sponsor ID
- Laryngotest / Laryngotest
- Conditions
- Intubation
- Keywords
- anesthesiology, randomized, laryngoscope, intubation, laryngeal exposition, laryngoscope blades, plastic single use blade, metallic single use blade
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,040 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 7 Apr 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.
The purpose of this study is to determinate if there is a difference in performance provided by three laryngoscope blades: plastic single use, metallic single use and metallic reusable blades.
Detailed description
Primary outcome: success of intubation at the first attempt
Secondary outcomes: quality of laryngeal exposition (Cormack and Lehanne modify grade), duration to success intubation, Intubation difficult Scale and result of intubation procedure
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: metallic single use blademetallic single use blade |
| 2 | Experimental | Device: plastic single use bladeplastic single use blade |
| 3 | Active comparator | Device: metallic reusable blademetallic reusable blade |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patient age over 18 who need general anesthesia with orothracheal intubation
Key exclusion criteria (6 listed)
- patient age under 18 or major assist
- presence of upper airway malformation or abnormality
- cervical or facial trauma
- previous difficult intubation known
- no use of curare
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 |
|---|---|---|
| metallic single use blademetallic single use blade | Device | 1 |
| plastic single use bladeplastic single use blade | Device | 2 |
| metallic reusable blademetallic reusable blade | Device | 3 |
Primary outcome
success of intubation at the first attempt
Time frame: immediately
4 secondary outcomes
quality of laryngeal exposition (Cormack and Lehanne modify grade)
Time frame: immediately
duration to success intubation
Time frame: immediately
Intubation difficult Scale
Time frame: Immediately
result of intubation procedure
Time frame: immediately
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 31 Mar 2010.
- Derived from this study: PubMed 23274619Buleon C, Parienti JJ, Lesage A, Grandin W, Pouliquen E, Flais F, Simonet T, Gerard JL, Hanouz JL. Comparison of plastic and metallic single-use and metallic reusable laryngoscope blades: a randomised controlled trial. Eur J Anaesthesiol. 2013 Apr;30(4):163-9. doi: 10.1097/EJA.0b013e32835c1cdb.
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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.
HANOUZ Jean-Luc, PHD study director
Anesthesiology critical care SAMU departement, University Hospital of Caen
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 metallic single use blade, plastic single use blade and metallic reusable blade in people with Intubation, run by University Hospital, Caen at 1 site in France.
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 6 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 31 Mar 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 France. 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?
success of intubation at the first attempt (time frame: immediately). 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 NCT00876967, 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 31 Mar 2010.