ChildrenNCT01212536
Airtraq Versus Conventional Laryngoscopy in Children
A study testing Airtraq laryngoscopy in people with Children and General Anesthesia, run by University Hospitals Bristol and Weston NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The investigators aim to compare the new paediatric Airtraq indirect optical laryngoscope with conventional direct laryngoscopy for tracheal intubation in a randomised crossover study during routine anaesthesia. Read more about this study
- Who is it for?
- Ages Up to 6 years
- Conditions the study is for
- Children, General Anesthesia, Intubation
- What is being tested?
- Airtraq laryngoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2010to Mar 2011
- 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 Up to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All children less than 6 years of age, in whom a size 2.5 - 5.5 tracheal tube would be considered suitable.
- Classified by the American Society of Anesthesiology (ASA) as grade 1-3.
- Scheduled for surgery under general anaesthesia, and in whom tracheal intubation and neuromuscular blocking drugs are planned to be used.
Who cannot join
- inability of patient or parents to understand the study or consent process
- known or suspected difficult airway
- ASA 4 and above
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Bristol Childrens hospital
Bristol, Bristol, BS2 8BJ
About this study
Official title: Randomised Controlled Trial of the Airtraq Optical Laryngoscope and Conventional Laryngoscopy in Children
The investigators aim to compare the new paediatric Airtraq indirect optical laryngoscope with conventional direct laryngoscopy for tracheal intubation in a randomised crossover study during routine anaesthesia. The investigators hypothesise that the Airtraq is as good as conventional laryngoscopy for tracheal intubation of infants and children. This will be an equivalence rather than a non-inferiority study.
- Conditions
- Children, General Anesthesia, Intubation
- Being tested
- Airtraq laryngoscopy
- Keywords
- children, intubation, laryngoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Airtraq laryngoscopyDevice
laryngoscopy and intubation
| Study group | Role | What they receive |
|---|---|---|
| Conventional | No intervention | conventional laryngoscopy for intubation |
| Airtraq | Experimental | laryngoscopy with Airtraq for intubation Receives: Device: Airtraq laryngoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
time taken to successful intubation
The primary outcome measure will be time taken to successful intubation. This will be recorded by a second operator using a handheld stopwatch or wall clock with second hand. Time will commence when the intubation device is handed to the anaesthetist, and stopped after the first successful inflation of the lungs (first upstroke of capnography trace).
Measured: 30 mins
Secondary outcomes (4)
Grade of laryngoscopy
Measured: 30 mins
POGO score
Measured: 30 mins
VAS ease of intubation
Measured: 30 mins
evidence of traumatic intubation
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2010 (estimated)
- Study startAug 2010
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChildrenStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Bristol and Weston NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Oxford University Hospitals NHS Trust
- Responsible party
- Principal investigator, Michelle White, University Hospitals Bristol and Weston NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01212536
- Sponsor's protocol ID
- CH/2009/3387
- Status last verified
- Dec 2011
- First submitted
- 15 Jul 2010
- Last updated
- 15 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial of the Airtraq Optical Laryngoscope and Conventional Laryngoscopy in Children
- ClinicalTrials.gov ID
- NCT01212536
- Acronym / sponsor ID
- CH/2009/3387
- Conditions
- Children, General Anesthesia, Intubation
- Keywords
- children, intubation, laryngoscope
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospitals Bristol and Weston NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Oxford University Hospitals NHS Trust
- Study start
- Aug 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 30 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.
The investigators aim to compare the new paediatric Airtraq indirect optical laryngoscope with conventional direct laryngoscopy for tracheal intubation in a randomised crossover study during routine anaesthesia. The investigators hypothesise that the Airtraq is as good as conventional laryngoscopy for tracheal intubation of infants and children. This will be an equivalence rather than a non-inferiority study.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional | No intervention | –conventional laryngoscopy for intubation |
| Airtraq | Experimental | Device: Airtraq laryngoscopylaryngoscopy with Airtraq for intubation |
Who may qualify
- Ages
- Up to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- All children less than 6 years of age, in whom a size 2.5 - 5.5 tracheal tube would be considered suitable.
- Classified by the American Society of Anesthesiology (ASA) as grade 1-3.
- Scheduled for surgery under general anaesthesia, and in whom tracheal intubation and neuromuscular blocking drugs are planned to be used.
Key exclusion criteria (3 listed)
- inability of patient or parents to understand the study or consent process
- known or suspected difficult airway
- ASA 4 and above
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 laryngoscopylaryngoscopy and intubation | Device | Airtraq |
Primary outcome
time taken to successful intubation
Time frame: 30 mins
The primary outcome measure will be time taken to successful intubation. This will be recorded by a second operator using a handheld stopwatch or wall clock with second hand. Time will commence when the intubation device is handed to the anaesthetist, and stopped after the first successful inflation of the lungs (first upstroke of capnography trace).
4 secondary outcomes
Grade of laryngoscopy
Time frame: 30 mins
POGO score
Time frame: 30 mins
VAS ease of intubation
Time frame: 30 mins
evidence of traumatic intubation
Time frame: 24 hours
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 15 Dec 2011.
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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 study testing Airtraq laryngoscopy in people with Children and General Anesthesia, run by University Hospitals Bristol and Weston NHS Foundation Trust at 1 site in United Kingdom.
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 3 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 15 Dec 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 United Kingdom. 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?
time taken to successful intubation (time frame: 30 mins). 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 15 Dec 2011.