Ear Based ProSeal LMANCT02257411
A Method to Determine the Size of Laryngeal Mask Airway (LMA)
A study testing Ear-sized based in people with Ear Based ProSeal LMA, run by Yeditepe University Hospital at 1 site in Turkey (Türkiye).
Trial summary
After institutional ethics board approval and written informed consent from parents, 197 children scheduled for routine genitourinary operation and in whom a LMA was indicated for anesthesia were included in the study. Read more about this study
- Who is it for?
- Ages Up to 15 years
- Conditions the study is for
- Ear Based ProSeal LMA
- What is being tested?
- Ear-sized based
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 197 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jun 2013to Jun 2013
- 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 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASA physical status I/II
- scheduled for genitourinary operation
- LMA was indicated for anesthesia
Who cannot join
- surgery lasting more than 3 h
- overweight or underweight patients
- gastroesophageal reflux
- risk of aspiration
- airway infection in the last six weeks
- decreased pulmonary or chest wall compliance.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Yeditepe University Hospital
Istanbul, Kozyatağı, 34752
About this study
Official title: A Simple Method to Determine the Size of the ProSeal LMA (PLMA) in Children
After institutional ethics board approval and written informed consent from parents, 197 children scheduled for routine genitourinary operation and in whom a LMA was indicated for anesthesia were included in the study. The size of the LMA was determined by choosing the size that was best matched with the auricle of the children. The results were compared with the standard method recommended by the manufacturer's weight-related guidelines. The patients were classified in different groups depending on the PLMA sizes determined by both methods. A kappa coefficient evaluated the agreement between both techniques.
- Conditions
- Ear Based ProSeal LMA
- Being tested
- Ear-sized based
- Keywords
- child, ear based, Proseal LMA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ear-sized basedDevice
the sizes of the PLMA determined with the ear-based formula were compared with the sizes according to the manufacturer's weight-based formula
| Study group | Role | What they receive |
|---|---|---|
| Ear-sized based and weight based formula | Active comparator | the sizes of the PLMA determined with the ear-based compared with the sizes according to the manufacturer's weight-based formula Receives: Device: Ear-sized based |
What is being measured
The primary outcome is the main question the study is designed to answer.
the sizes of the PLMA determined with the ear-based formula
we were to determine whether the size of the auricle could be used as a proxy for the appropriate size of the PLMA
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2014 (estimated)
- Study startJun 2013
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ear Based ProSeal LMAStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yeditepe University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murat Haliloglu, Yeditepe University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02257411
- Sponsor's protocol ID
- 346
- Status last verified
- Oct 2014
- First submitted
- 22 Sep 2014
- Last updated
- 6 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Simple Method to Determine the Size of the ProSeal LMA (PLMA) in Children
- ClinicalTrials.gov ID
- NCT02257411
- Acronym / sponsor ID
- 346
- Conditions
- Ear Based ProSeal LMA
- Keywords
- child, ear based, Proseal LMA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- Yeditepe University HospitalUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 6 Oct 2014 (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.
After institutional ethics board approval and written informed consent from parents, 197 children scheduled for routine genitourinary operation and in whom a LMA was indicated for anesthesia were included in the study. The size of the LMA was determined by choosing the size that was best matched with the auricle of the children. The results were compared with the standard method recommended by the manufacturer's weight-related guidelines. The patients were classified in different groups depending on the PLMA sizes determined by both methods. A kappa coefficient evaluated the agreement between both techniques.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ear-sized based and weight based formula | Active comparator | Device: Ear-sized basedthe sizes of the PLMA determined with the ear-based compared with the sizes according to the manufacturer's weight-based formula |
Who may qualify
- Ages
- Up to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- ASA physical status I/II
- scheduled for genitourinary operation
- LMA was indicated for anesthesia
Key exclusion criteria (6 listed)
- surgery lasting more than 3 h
- overweight or underweight patients
- gastroesophageal reflux
- risk of aspiration
- airway infection in the last six weeks
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 |
|---|---|---|
| Ear-sized basedthe sizes of the PLMA determined with the ear-based formula were compared with the sizes according to the manufacturer's weight-based formula | Device | Ear-sized based and weight based formula |
Primary outcome
the sizes of the PLMA determined with the ear-based formula
Time frame: One year
we were to determine whether the size of the auricle could be used as a proxy for the appropriate size of the PLMA
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 6 Oct 2014.
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 Ear-sized based in people with Ear Based ProSeal LMA, run by Yeditepe University Hospital at 1 site in Turkey (Türkiye).
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 6 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 6 Oct 2014. 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 Turkey (Türkiye). 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?
the sizes of the PLMA determined with the ear-based formula (time frame: One year). 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 6 Oct 2014.