Device Success RateNCT01425151
The i-GelTM. A Randomized, Crossover Study With the Laryngeal Mask Airway ProSealTM in Anesthetized Pediatric Patients
A study testing i-Gel and ProSeal in people with Device Success Rate and Device Performance, run by Schulthess Klinik at 2 sites in 2 countries.
Trial summary
In the following randomized, crossover study, the investigators test the hypothesis that ease of insertion and oropharyngeal leak pressure differ between the LMA ProSealTM and the i-GelTM in anesthetized pediatric patients. Read more about this study
- Who is it for?
- Ages 18 months to 6 years
- Conditions the study is for
- Device Success Rate, Device Performance
- What is being tested?
- i-Gel and ProSeal
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jan 2010to Sep 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 18 months to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASA I and II
- Age 1.5-6 years
Who cannot join
- known or predicted difficult airway
- body mass index > 35 kg m-2
- risk of aspiration
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Austria1 site
Klinik für Anästhesie und Allgemeine Intensivmedizin
Innsbruck, 6020
About this study
In the following randomized, crossover study, the investigators test the hypothesis that ease of insertion and oropharyngeal leak pressure differ between the LMA ProSealTM and the i-GelTM in anesthetized pediatric patients.
- Conditions
- Device Success Rate, Device Performance
- Being tested
- i-Gel, ProSeal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
i-GelDevice
Oropharyngeal leak pressure Insertion success
ProSealDevice
Oropharyngeal leak pressure Insertion success
| Study group | Role | What they receive |
|---|---|---|
| i-Gel | Active comparator | Not described Receives: Device: i-Gel |
| ProSeal | Experimental | Not described Receives: Device: ProSeal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oropharyngeal leak pressure
Measured: 10 Minutes
Secondary outcomes (1)
Insertion success rate
Measured: 1 Minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2011 (estimated)
- Study startJan 2010
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Device Success RateStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Schulthess Klinik
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ChristianKeller, Schulthess Klinik
- Investigators
- Christian Keller, MD, M.Sc., Principal investigator, Schulthess Klinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01425151
- Sponsor's protocol ID
- Schulthess_Anä_2
- Status last verified
- Sep 2011
- First submitted
- 26 Aug 2011
- Last updated
- 22 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The i-GelTM. A Randomized, Crossover Study With the Laryngeal Mask Airway ProSealTM in Anesthetized Pediatric Patients
- ClinicalTrials.gov ID
- NCT01425151
- Acronym / sponsor ID
- Schulthess_Anä_2
- Conditions
- Device Success Rate, Device Performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Schulthess KlinikUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 29 Aug 2011 (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.
In the following randomized, crossover study, the investigators test the hypothesis that ease of insertion and oropharyngeal leak pressure differ between the LMA ProSealTM and the i-GelTM in anesthetized pediatric patients.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| i-Gel | Active comparator | Device: i-Gel |
| ProSeal | Experimental | Device: ProSeal |
Who may qualify
- Ages
- 18 months to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- ASA I and II
- Age 1.5-6 years
Key exclusion criteria (3 listed)
- known or predicted difficult airway
- body mass index > 35 kg m-2
- risk of aspiration
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 |
|---|---|---|
| i-GelOropharyngeal leak pressure Insertion success | Device | i-Gel |
| ProSealOropharyngeal leak pressure Insertion success | Device | ProSeal |
Primary outcome
Oropharyngeal leak pressure
Time frame: 10 Minutes
1 secondary outcome
Insertion success rate
Time frame: 1 Minute
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 22 Sep 2011.
Related trials for Device Success Rate
Recruiting
Does Increasing the Compression Pause From 3 to 5 Seconds in Mechanical Compression Devices Increase Ventilation Success Rate and Return of Spontaneous Circulation?
Cardiac Arrest (CA)
Not yet recruitingObservational study
The Effect of Vascular Imaging Devices on Success Rates of Peripheral Vascular Access in Pediatric Patients
Peripheral Vascular Access in Pediatric Patients, Peptic Ulcer
Active, not recruitingObservational study
Retrospective Data Analysis With the Aim to Determine the Success Rate of Endotracheal Intubation in the First Attempt in the Zug Rescue Service With Various Airway Devices Already in Everyday Use
Respiratory Insufficiency, 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.
Christian Keller, MD, M.Sc. principal investigator
Schulthess Klinik
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing i-Gel and ProSeal in people with Device Success Rate and Device Performance, run by Schulthess Klinik at 2 sites in 2 countries.
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 2 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 22 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria, Switzerland. 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?
Oropharyngeal leak pressure (time frame: 10 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 22 Sep 2011.