Endotracheal IntubationNCT00874016
Airtraq Versus Standard Direct Laryngoscopy in the Pediatric Airway
A study testing Airtraq and Direct Laryngoscopy in people with Endotracheal Intubation, run by IWK Health Centre at 1 site in Canada.
Trial summary
Time to intubate, view to glottic opening and success rate are not different when Airtraq technique is used compared to standard direct laryngoscopy in children. Read more about this study
- Who is it for?
- Ages Up to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Endotracheal Intubation
- What is being tested?
- Airtraq and Direct Laryngoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2009to Dec 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 Up to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- elective surgery requiring endotracheal intubation
Who cannot join
- predicted difficult bag-mask ventilation
- predicted difficult intubation
- rapid sequence induction
- emergency endotracheal intubation
- hemodynamic instability
- emergency surgery
- non-english speaking caregivers/parents
Trial locations and contacts
1 site in 1 country.
Canada1 site
Department of Pediatric Anesthesia, IWK Health Centre
Halifax, Nova Scotia, B3K 6R8
About this study
Official title: A Comparison of the Airtraq and Standard Direct Laryngoscopy in the Pediatric Airway - A Randomized Trial.
Time to intubate, view to glottic opening and success rate are not different when Airtraq technique is used compared to standard direct laryngoscopy in children.
Read the detailed description
50 children (age 5 years and 11 month or younger) with expected easy intubation, scheduled for elective surgery requiring endotracheal intubation are enrolled.
- Conditions
- Endotracheal Intubation
- Being tested
- Airtraq, Direct Laryngoscopy
- Keywords
- intubation, Airtraq, pediatric, airway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AirtraqDevice
Intubation using Airtraq
Direct LaryngoscopyDevice
Intubation using direct laryngoscopy
| Study group | Role | What they receive |
|---|---|---|
| Airtraq | Active comparator | Intubation with the use of the Airtraq Receives: Device: Airtraq |
| Direct Laryngoscopy | Active comparator | Intubation using direct laryngoscopy Receives: Device: Direct Laryngoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to intubation
Measured: 1 day
Secondary outcomes (1)
Percentage of glottic opening seen
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionAug 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Endotracheal 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- IWK Health Centre
- Sponsor type
- University, hospital or other
- Investigators
- Arnim Vlatten, MD, Principal investigator, IWK Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00874016
- Sponsor's protocol ID
- Airtraq 4469
- Status last verified
- Apr 2009
- First submitted
- 1 Apr 2009
- Last updated
- 16 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Maharaj CH, Costello JF, Harte BH, Laffey JG. Evaluation of the Airtraq and Macintosh laryngoscopes in patients at increased risk for difficult tracheal intubation. Anaesthesia. 2008 Feb;63(2):182-8. doi: 10.1111/j.1365-2044.2007.05316.x.
PubMed 18211450Maharaj CH, O'Croinin D, Curley G, Harte BH, Laffey JG. A comparison of tracheal intubation using the Airtraq or the Macintosh laryngoscope in routine airway management: A randomised, controlled clinical trial. Anaesthesia. 2006 Nov;61(11):1093-9. doi: 10.1111/j.1365-2044.2006.04819.x.
PubMed 17042849
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Airtraq and Standard Direct Laryngoscopy in the Pediatric Airway - A Randomized Trial.
- ClinicalTrials.gov ID
- NCT00874016
- Acronym / sponsor ID
- Airtraq 4469
- Conditions
- Endotracheal Intubation
- Keywords
- intubation, Airtraq, pediatric, airway
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- IWK Health CentreUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 2 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.
Time to intubate, view to glottic opening and success rate are not different when Airtraq technique is used compared to standard direct laryngoscopy in children.
Detailed description
50 children (age 5 years and 11 month or younger) with expected easy intubation, scheduled for elective surgery requiring endotracheal intubation are enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Airtraq | Active comparator | Device: AirtraqIntubation with the use of the Airtraq |
| Direct Laryngoscopy | Active comparator | Device: Direct LaryngoscopyIntubation using direct laryngoscopy |
Who may qualify
- Ages
- Up to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- elective surgery requiring endotracheal intubation
Key exclusion criteria (7 listed)
- predicted difficult bag-mask ventilation
- predicted difficult intubation
- rapid sequence induction
- emergency endotracheal intubation
- hemodynamic instability
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 |
|---|---|---|
| AirtraqIntubation using Airtraq | Device | Airtraq |
| Direct LaryngoscopyIntubation using direct laryngoscopy | Device | Direct Laryngoscopy |
Primary outcome
Time to intubation
Time frame: 1 day
1 secondary outcome
Percentage of glottic opening seen
Time frame: 1 day
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 16 Dec 2010.
- Background: PubMed 18211450Maharaj CH, Costello JF, Harte BH, Laffey JG. Evaluation of the Airtraq and Macintosh laryngoscopes in patients at increased risk for difficult tracheal intubation. Anaesthesia. 2008 Feb;63(2):182-8. doi: 10.1111/j.1365-2044.2007.05316.x.
- Background: PubMed 17042849Maharaj CH, O'Croinin D, Curley G, Harte BH, Laffey JG. A comparison of tracheal intubation using the Airtraq or the Macintosh laryngoscope in routine airway management: A randomised, controlled clinical trial. Anaesthesia. 2006 Nov;61(11):1093-9. doi: 10.1111/j.1365-2044.2006.04819.x.
Related trials for Endotracheal Intubation
Not yet recruitingObservational study
AI-assisted Tracheal Intubation in Children
Intubation
Not yet recruiting
AI Smart Glasses Feedback for Intubation Training in Medical Students
Intubation, Intratracheal, Medical Education
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
Recruiting
Effect of a Brief Educational Intervention on Endotracheal Tube Cuff Pressure
Intubation, Endotracheal Tube Cuff Pressure
Recruiting
Hyperangulated vs Standard Videolaryngoscopy vs Direct Laryngoscopy for Double-Lumen Endobronchial Tube Intubation
Endobronchial Intubation, Double Lumen Tube Intubation
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.
Arnim Vlatten, MD principal investigator
IWK Health Centre
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 and Direct Laryngoscopy in people with Endotracheal Intubation, run by IWK Health Centre at 1 site in Canada.
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 7 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 16 Dec 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 Canada. 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 to intubation (time frame: 1 day). 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 NCT00874016, which also lists 2 linked publications.
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 16 Dec 2010.