Urologic SurgeryPhase 4cLMANCT02000791
Does Laryngoscopic Tecnique Facilitate cLMA Insertion?
A Phase 4 study testing Comparison of fibreoptic view in people with Urologic Surgery, run by Diskapi Yildirim Beyazit Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
it is compared that laryngeal mask insertion with standard technique and laryngoscopic technique Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Urologic Surgery
- What is being tested?
- Comparison of fibreoptic view
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Dec 2013to May 2014
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 age
- under urologic surgery patient
Who cannot join
- Uper respiratory infection
- Full stomach
- BMI over 40
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Diskapi Yildiim Beyazit Eduation and Research Hospital
Ankara
Murat Alper, MD, +905326734310
Tuğba Arslan
About this study
it is compared that laryngeal mask insertion with standard technique and laryngoscopic technique
Read the detailed description
Is there any releation between insertion succes rate and difficult intubation criteria. success of the first attempt laryngeal mask insertion, patient response of laryngeal mask placement. And also during the implementation of these two techniques; the effects on heart rate and blood pressure and postoperative complications were investigated.
- Conditions
- Urologic Surgery
- Being tested
- Comparison of fibreoptic view
- Keywords
- cLMA, laryngoscopy, fiberoptic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparison of fibreoptic viewOther
| Study group | Role | What they receive |
|---|---|---|
| cLMA insertion via laryngoscopic technique | Experimental | Comparison of cLMA insertion via laryngoscope view by fiberscope Receives: Other: Comparison of fibreoptic view |
| cLMA insertion via standart technique | Active comparator | Comparison of cLMA insertion via standart technique view by fiberscope Receives: Other: Comparison of fibreoptic view |
What is being measured
The primary outcome is the main question the study is designed to answer.
İnvestigate to easy of insertion whether standart or laryngoscopic technique
Measured: 1 min after insertion
Secondary outcomes (1)
Fiberoptic view
Measured: 1 min after insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionFeb 2014 (estimated)
- Study completionMay 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urologic 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Tugba Arslan, Diskapi Yildirim Beyazit Education and Research Hospital
- Investigators
- Tugba Arslan, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02000791
- Sponsor's protocol ID
- laryngeal mask
- Acronym
- cLMA
- Status last verified
- Nov 2013
- First submitted
- 21 Nov 2013
- Last updated
- 4 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Laryngoscopic Tecnique Facilitate cLMA Insertion?
- ClinicalTrials.gov ID
- NCT02000791
- Acronym / sponsor ID
- cLMA / laryngeal mask
- Conditions
- Urologic Surgery
- Keywords
- cLMA, laryngoscopy, fiberoptic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research HospitalOther government
- Study start
- Dec 2013
- Primary completion
- Feb 2014 (estimated)
- Study completion
- May 2014 (estimated)
- First posted
- 4 Dec 2013 (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.
it is compared that laryngeal mask insertion with standard technique and laryngoscopic technique
Detailed description
Is there any releation between insertion succes rate and difficult intubation criteria. success of the first attempt laryngeal mask insertion, patient response of laryngeal mask placement. And also during the implementation of these two techniques; the effects on heart rate and blood pressure and postoperative complications were investigated.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cLMA insertion via laryngoscopic technique | Experimental | Other: Comparison of fibreoptic viewComparison of cLMA insertion via laryngoscope view by fiberscope |
| cLMA insertion via standart technique | Active comparator | Other: Comparison of fibreoptic viewComparison of cLMA insertion via standart technique view by fiberscope |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Over 18 age
- under urologic surgery patient
Key exclusion criteria (3 listed)
- Uper respiratory infection
- Full stomach
- BMI over 40
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 |
|---|---|---|
| Comparison of fibreoptic view | Other | cLMA insertion via laryngoscopic technique, cLMA insertion via standart technique |
Primary outcome
İnvestigate to easy of insertion whether standart or laryngoscopic technique
Time frame: 1 min after insertion
1 secondary outcome
Fiberoptic view
Time frame: 1 min after insertion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2013.
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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.
Tugba Arslan, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Comparison of fibreoptic view in people with Urologic Surgery, run by Diskapi Yildirim Beyazit Education and Research 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 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: status not confirmed, as of the sponsor's last update on 4 Dec 2013. 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tuğba Arslan, MD (+905074378919, tuba.kokulu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
İnvestigate to easy of insertion whether standart or laryngoscopic technique (time frame: 1 min after insertion). 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 4 Dec 2013.