IntubationNCT01090726
Intubation With Storz Videolaryngoscope® Versus Airtraq® - in an Infant Population
A study testing Storz videolaryngoscope and Airtraq in people with Intubation and Videolaryngoscopy, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The purpose of the pilot study is to compare new laryngoscopes for infants by assessing the equipment best suited to assist the intubation, with the best overview, shortest time to intubation and use these numbers to make a sample size calculation for the full protocol. Read more about this study
- Who is it for?
- Ages 1 month to 2 years
- Conditions the study is for
- Intubation, Videolaryngoscopy, Infant
- What is being tested?
- Storz videolaryngoscope and Airtraq
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2010to Oct 2010
- 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 1 month to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Elective surgical patients ASA-class 1-2 below the age of 2 years, with indication for intubation.
- Informed consent from parent.
- The parents must have legal custody of the child.
- The parents must be able to read and understand Danish.
Who cannot join
- Expected difficult airway.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet
Copenhagen, 2100
About this study
The purpose of the pilot study is to compare new laryngoscopes for infants by assessing the equipment best suited to assist the intubation, with the best overview, shortest time to intubation and use these numbers to make a sample size calculation for the full protocol. The investigators hypothesis is that the Storz videolaryngoscope® has a better success rate than infants (<2 years). The patients will be optimally anaesthetized with neuromuscular blockade for the intubation. All patient will be evaluated with af Macintosh blade laryngoscope, with an Airtraq® or a Storz videolaryngoscope®, and finally intubated with the other one of the later, which the patient was randomized to.
- Conditions
- Intubation, Videolaryngoscopy, Infant
- Being tested
- Storz videolaryngoscope, Airtraq
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Storz videolaryngoscopeDevice
Storz videolaryngoscope being used for the actual intubation
AirtraqDevice
Airtraq being used for the actual intubation
| Study group | Role | What they receive |
|---|---|---|
| Storz videolaryngoscope | Experimental | Macintosh overview followed by Airtraq overview followed by Storz videolaryngoscope overview and intubation. Receives: Device: Storz videolaryngoscope |
| Airtraq | Active comparator | Macintosh overview followed by Storz videolaryngoscope overview followed by Airtraq overview and intubation. Receives: Device: Airtraq |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate
Succes is defined by intubation being executed in the first try.
Measured: 5 minutes
Secondary outcomes (6)
Time to Cormack evaluation
Measured: 5 minutes
Time to intubation
Measured: 5 minutes
Number of intubation attempts
Measured: 5 Minutes
Quality of laryngeal overview before intubation
Evaluated by Cormack score
Measured: 5 Minutes
Prevalence of post intubation stridor
Measured: 12 hours
Intubation conditions
Measured: 5 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionOct 2010
- Study completionOct 2010
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 IntubationStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01090726
- Sponsor's protocol ID
- 1A-INF-STORZ-AIR
- Status last verified
- Mar 2010
- First submitted
- 18 Mar 2010
- Last updated
- 13 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Lingappan K, Neveln N, Arnold JL, Fernandes CJ, Pammi M. Videolaryngoscopy versus direct laryngoscopy for tracheal intubation in neonates. Cochrane Database Syst Rev. 2023 May 12;5(5):CD009975. doi: 10.1002/14651858.CD009975.pub4.
PubMed 37171122Sorensen MK, Holm-Knudsen R. Endotracheal intubation with airtraq(R) versus storz(R) videolaryngoscope in children younger than two years - a randomized pilot-study. BMC Anesthesiol. 2012 Apr 30;12:7. doi: 10.1186/1471-2253-12-7.
PubMed 22545575
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intubation With Storz Videolaryngoscope® Versus Airtraq® - in an Infant Population
- ClinicalTrials.gov ID
- NCT01090726
- Acronym / sponsor ID
- 1A-INF-STORZ-AIR
- Conditions
- Intubation, Videolaryngoscopy, Infant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 22 Mar 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 purpose of the pilot study is to compare new laryngoscopes for infants by assessing the equipment best suited to assist the intubation, with the best overview, shortest time to intubation and use these numbers to make a sample size calculation for the full protocol. The investigators hypothesis is that the Storz videolaryngoscope® has a better success rate than infants (<2 years). The patients will be optimally anaesthetized with neuromuscular blockade for the intubation. All patient will be evaluated with af Macintosh blade laryngoscope, with an Airtraq® or a Storz videolaryngoscope®, and finally intubated with the other one of the later, which the patient was randomized to.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Storz videolaryngoscope | Experimental | Device: Storz videolaryngoscopeMacintosh overview followed by Airtraq overview followed by Storz videolaryngoscope overview and intubation. |
| Airtraq | Active comparator | Device: AirtraqMacintosh overview followed by Storz videolaryngoscope overview followed by Airtraq overview and intubation. |
Who may qualify
- Ages
- 1 month to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Elective surgical patients ASA-class 1-2 below the age of 2 years, with indication for intubation.
- Informed consent from parent.
- The parents must have legal custody of the child.
- The parents must be able to read and understand Danish.
Key exclusion criteria (1 listed)
- Expected difficult airway.
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 |
|---|---|---|
| Storz videolaryngoscopeStorz videolaryngoscope being used for the actual intubation | Device | Storz videolaryngoscope |
| AirtraqAirtraq being used for the actual intubation | Device | Airtraq |
Primary outcome
Success rate
Time frame: 5 minutes
Succes is defined by intubation being executed in the first try.
6 secondary outcomes
Time to Cormack evaluation
Time frame: 5 minutes
Time to intubation
Time frame: 5 minutes
Number of intubation attempts
Time frame: 5 Minutes
Quality of laryngeal overview before intubation
Time frame: 5 Minutes
Prevalence of post intubation stridor
Time frame: 12 hours
Intubation conditions
Time frame: 5 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 13 Dec 2010.
- Derived from this study: PubMed 37171122Lingappan K, Neveln N, Arnold JL, Fernandes CJ, Pammi M. Videolaryngoscopy versus direct laryngoscopy for tracheal intubation in neonates. Cochrane Database Syst Rev. 2023 May 12;5(5):CD009975. doi: 10.1002/14651858.CD009975.pub4.
- Derived from this study: PubMed 22545575Sorensen MK, Holm-Knudsen R. Endotracheal intubation with airtraq(R) versus storz(R) videolaryngoscope in children younger than two years - a randomized pilot-study. BMC Anesthesiol. 2012 Apr 30;12:7. doi: 10.1186/1471-2253-12-7.
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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 Storz videolaryngoscope and Airtraq in people with Intubation and Videolaryngoscopy, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 4 inclusion and 1 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 13 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 Denmark. 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?
Success rate (time frame: 5 minutes). 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 NCT01090726, 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 13 Dec 2010.