IntubationNCT00917566
Evaluation of Airtraq in Pediatric
A study testing Airtraq and Macintoch in people with Intubation, run by King Khaled Eye Specialist Hospital at 1 site in Saudi Arabia.
Trial summary
This study indented to evaluate the use of Optical laryngoscope in pediatric Read more about this study
- Who is it for?
- Ages 2 to 10 years
- Conditions the study is for
- Intubation
- What is being tested?
- Airtraq and Macintoch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Apr 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 2 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Healthy children undergoing general anesthesia required tracheal intubation.
Who cannot join
- History of difficult intubation.
- Risk of aspiration.
- Children with cardiovascular disease.
- Children with respiratory disease.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
king Khaled Eye Specialist hospital
Riyadh, Riyadh Region, 11462
About this study
Official title: Evaluation of Airtraq in Pediatric Population: A Prospective Randomized Study
This study indented to evaluate the use of Optical laryngoscope in pediatric
Read the detailed description
The authors are welling to study how intubation will differ if Airtraq optical laryngoscope used in pediatrics
- Conditions
- Intubation
- Being tested
- Airtraq, Macintoch
- Keywords
- Airtraq, Pediatric
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AirtraqDevice
Also called Optical laryngoscope
intubation with airtraq
MacintochDevice
Also called Standard laryngoscope
use Macintoch laryngoscope for intubation
| Study group | Role | What they receive |
|---|---|---|
| Airtraq group | Active comparator | Use Airtraq for intubation Receives: Device: Airtraq |
| Macintoch gorup | Active comparator | Use Macintoch laryngoscope for intubation Receives: Device: Macintoch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of intubation
Measured: two minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2009 (estimated)
- Study startApr 2009
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Khaled Eye Specialist Hospital
- Sponsor type
- Other government
- Investigators
- Waleed Riad, MD, AB, SB, Principal investigator, King Khaled Eye Specialist Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00917566
- Sponsor's protocol ID
- RP 0909
- Status last verified
- Nov 2009
- First submitted
- 9 Jun 2009
- Last updated
- 19 Nov 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Airtraq in Pediatric Population: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT00917566
- Acronym / sponsor ID
- RP 0909
- Conditions
- Intubation
- Keywords
- Airtraq, Pediatric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- King Khaled Eye Specialist HospitalOther government
- Study start
- Apr 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 10 Jun 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.
This study indented to evaluate the use of Optical laryngoscope in pediatric
Detailed description
The authors are welling to study how intubation will differ if Airtraq optical laryngoscope used in pediatrics
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Airtraq group | Active comparator | Device: AirtraqUse Airtraq for intubation |
| Macintoch gorup | Active comparator | Device: MacintochUse Macintoch laryngoscope for intubation |
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Healthy children undergoing general anesthesia required tracheal intubation.
Key exclusion criteria (4 listed)
- History of difficult intubation.
- Risk of aspiration.
- Children with cardiovascular disease.
- Children with respiratory disease.
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 |
|---|---|---|
| AirtraqAlso: Optical laryngoscopeintubation with airtraq | Device | Airtraq group |
| MacintochAlso: Standard laryngoscopeuse Macintoch laryngoscope for intubation | Device | Macintoch gorup |
Primary outcome
Duration of intubation
Time frame: two minutes
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 19 Nov 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.
Waleed Riad, MD, AB, SB principal investigator
King Khaled Eye Specialist Hospital
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 Macintoch in people with Intubation, run by King Khaled Eye Specialist Hospital at 1 site in Saudi Arabia.
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 19 Nov 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 Saudi Arabia. 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?
Duration of intubation (time frame: two minutes). 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 19 Nov 2009.