Bladder TumourPhase 4C-LMANCT01876836
Clasic Laryngeal Mask Airway(C-LMA) and I-gel Releated Regurgitation and Complications
A Phase 4 study testing i-gel and C-LMA in people with Bladder Tumour and Prostate Hyperplasia, run by Diskapi Yildirim Beyazit Education and Research Hospital at 2 sites in Turkey (Türkiye).
Trial summary
1. i-gel 2. C-LMA Compare the effect on gastroeosephageal reflux Postoperative complicatios. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Bladder Tumour, Prostate Hyperplasia
- What is being tested?
- i-gel and C-LMA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- Jul 2013to Sep 2013
- 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 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-II
- Adult
- Elective surgery
- Bladder tumour
- Prostat hyperplasi
Who cannot join
- Emergency surgery
- Hiatal hernia
- Gastroeosephageal reflux disease
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
DiskapiYBERH
Ankara, Altındağ, 06610
Murat Alper, Prof., +903125962000, muratalper@hotmail.com
Reyhan Polat, MD
DiskapiYBERH
Ankara, Altındağ, 06610
Reyhan Polat, MD, +905326734310, reyhanp9@gmail.com
Reyhan Polat, MD
About this study
Official title: Comparation the Effect of C-LMA and I-gel in Regurgitation and Postoperative Complications
- i-gel
- C-LMA
Compare the effect on gastroeosephageal reflux Postoperative complicatios.
Read the detailed description
120 ASA I-II adult patients. Patients were randomised into two groups
- i-gel
- C-LMA Volume controlled ventilation, general anesthesia Asses Gastroeosephageal reflux, sore throat, coughing, dysphagia,dysphonia recorded.
- Conditions
- Bladder Tumour, Prostate Hyperplasia
- Being tested
- i-gel, C-LMA
- Keywords
- i-gel, C-LMA, gastroeosephageal reflux, sore troat
- Medical subject headings
- Urinary Bladder Neoplasms, Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
i-gelDevice
Also called supraglottic airway device
i-gel placed after induction
C-LMADevice
Also called supraglottic airway device
placed after induction
| Study group | Role | What they receive |
|---|---|---|
| i-gel | Experimental | i-gel placed after induction Receives: Device: i-gel |
| C-LMA | Active comparator | C-LMA placed after induction Receives: Device: C-LMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ph MEASUREMENT
The ph of the secretions on the airway device will be measurd with a Ph-meter
Measured: 1 MİNUTE AFTER EXTUBATİON
Secondary outcomes (1)
Bleu dye on the airway device
The airway device will be examined with fiberoptic endoscope after placement
Measured: 5 min after placenent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2013 (estimated)
- Study startJul 2013
- Primary completionAug 2013 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder TumourStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Reyhan Polat, Diskapi Yildirim Beyazit Education and Research Hospital
- Investigators
- Reyhan Polat, MD, Principal investigator, Diskapi Yildirim Beyazit Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01876836
- Acronym
- C-LMA
- Status last verified
- Jun 2013
- First submitted
- 10 Jun 2013
- Last updated
- 13 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparation the Effect of C-LMA and I-gel in Regurgitation and Postoperative Complications
- ClinicalTrials.gov ID
- NCT01876836
- Acronym / sponsor ID
- C-LMA
- Conditions
- Bladder Tumour, Prostate Hyperplasia
- Keywords
- i-gel, C-LMA, gastroeosephageal reflux, sore troat
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research HospitalOther government
- Study start
- Jul 2013
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 13 Jun 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.
- i-gel
- C-LMA
Compare the effect on gastroeosephageal reflux Postoperative complicatios.
Detailed description
120 ASA I-II adult patients. Patients were randomised into two groups
- i-gel
- C-LMA Volume controlled ventilation, general anesthesia Asses Gastroeosephageal reflux, sore throat, coughing, dysphagia,dysphonia recorded.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| i-gel | Experimental | Device: i-geli-gel placed after induction |
| C-LMA | Active comparator | Device: C-LMAC-LMA placed after induction |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ASA I-II
- Adult
- Elective surgery
- Bladder tumour
- Prostat hyperplasi
Key exclusion criteria (3 listed)
- Emergency surgery
- Hiatal hernia
- Gastroeosephageal reflux disease
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-gelAlso: supraglottic airway devicei-gel placed after induction | Device | i-gel |
| C-LMAAlso: supraglottic airway deviceplaced after induction | Device | C-LMA |
Primary outcome
Ph MEASUREMENT
Time frame: 1 MİNUTE AFTER EXTUBATİON
The ph of the secretions on the airway device will be measurd with a Ph-meter
1 secondary outcome
Bleu dye on the airway device
Time frame: 5 min after placenent
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 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.
Reyhan Polat, MD principal investigator
Diskapi Yildirim Beyazit Education and Research Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing i-gel and C-LMA in people with Bladder Tumour and Prostate Hyperplasia, run by Diskapi Yildirim Beyazit Education and Research Hospital at 2 sites 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 5 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 13 Jun 2013. 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 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 Reyhan Polat, MD (+905326734310, reyhanp9@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ph MEASUREMENT (time frame: 1 MİNUTE AFTER EXTUBATİON). 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 13 Jun 2013.