Adenoidectomy SurgeryPhase 4NCT02708043
Laryngeal Mask Airway for Adenoidectomies (LMAA)
A Phase 4 study testing Flexible-Laryngeal Mask Airway in people with Adenoidectomy Surgery and Flexible-Laryngeal Mask Airway, run by Baskent University.
Trial summary
The current study retrospectively assesses laryngeal mask airway use during pediatric adenoidectomies in terms of patient safety, comfort, complications and surgeon satisfaction levels. Read more about this study
- Who is it for?
- Ages 1 year to 16 years
- Conditions the study is for
- Adenoidectomy Surgery, Flexible-Laryngeal Mask Airway
- What is being tested?
- Flexible-Laryngeal Mask Airway
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 814 participants
- Where
- No sites listed yet
- Study dates
- Jun 2012to Dec 2015
- Phase
- Phase 4
- 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 year to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1-16 years of age
- ASA I-II
- Scheduled for elective adenoidectomy under general anesthesia with F-LMA between June 2012 and November 2015.
Who cannot join
- Emergency
- Extreme obesity
- Sign of clinical significant infection.
About this study
Official title: The Use of Laryngeal Mask Airway for Adenoidectomies: An Experience of 814 Paediatric Patients
The current study retrospectively assesses laryngeal mask airway use during pediatric adenoidectomies in terms of patient safety, comfort, complications and surgeon satisfaction levels.
- Being tested
- Flexible-Laryngeal Mask Airway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexible-Laryngeal Mask AirwayOther
| Study group | Role | What they receive |
|---|---|---|
| F-LMA group | Other | LMA were placed to 814 patients for adenoidectomy surgery. Researchers evaluated flexible laryngeal mask airway use during pediatric adenoidectomies in terms of patient safety, comfort, complications and surgeon satisfaction levels. Receives: Other: Flexible-Laryngeal Mask Airway |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of failed LMA (0=failed, 1=good)
Measured: 3 year
Secondary outcomes (1)
Surgeon satisfaction level (0=bad, 1=same, 2=good)
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2016 (estimated)
- Study startJun 2012
- Primary completionNov 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenoidectomy SurgeryStudies 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 4
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 814 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozlem Ozmete, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02708043
- Sponsor's protocol ID
- KA 15-321
- Status last verified
- Mar 2016
- First submitted
- 21 Feb 2016
- Last updated
- 15 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Laryngeal Mask Airway for Adenoidectomies: An Experience of 814 Paediatric Patients
- ClinicalTrials.gov ID
- NCT02708043
- Acronym / sponsor ID
- KA 15-321
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 814 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Nov 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 15 Mar 2016 (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 current study retrospectively assesses laryngeal mask airway use during pediatric adenoidectomies in terms of patient safety, comfort, complications and surgeon satisfaction levels.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| F-LMA group | Other | Other: Flexible-Laryngeal Mask AirwayLMA were placed to 814 patients for adenoidectomy surgery. Researchers evaluated flexible laryngeal mask airway use during pediatric adenoidectomies in terms of patient safety, comfort, complications and surgeon satisfaction levels. |
Who may qualify
- Ages
- 1 year to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 1-16 years of age
- ASA I-II
- Scheduled for elective adenoidectomy under general anesthesia with F-LMA between June 2012 and November 2015.
Key exclusion criteria (3 listed)
- Emergency
- Extreme obesity
- Sign of clinical significant infection.
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 |
|---|---|---|
| Flexible-Laryngeal Mask Airway | Other | F-LMA group |
Primary outcome
The incidence of failed LMA (0=failed, 1=good)
Time frame: 3 year
1 secondary outcome
Surgeon satisfaction level (0=bad, 1=same, 2=good)
Time frame: 3 year
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 15 Mar 2016.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Flexible-Laryngeal Mask Airway in people with Adenoidectomy Surgery and Flexible-Laryngeal Mask Airway, run by Baskent University.
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 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 15 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 incidence of failed LMA (0=failed, 1=good) (time frame: 3 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 15 Mar 2016.