Ureteral CalculiNCT04186455
Comparison of Laryngeal Masks in Urethral Cystoscopic Surgery Operations: a Prospective Randomized Clinical Study
A study testing proseal and baska-mask in people with Ureteral Calculi, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
The use of Laryngeal masks are increased.This study aimed to compare lma pro seal and baska -mask in urethral retrograde sistoscopy operations. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ureteral Calculi
- What is being tested?
- proseal and baska-mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Dec 2019to 7 Feb 2022
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- undergoing elective urs operations
- bmı<35
- ASA I-II
Who cannot join
- bmı>35
- ASA III-IV
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Pro Seal and Baska-mask
The use of Laryngeal masks are increased.This study aimed to compare lma pro seal and baska -mask in urethral retrograde sistoscopy operations.
Read the detailed description
The use of Laryngeal masks are increased. Aimed to compare lma pro seal and baska -mask in urologic retrograde sistoscopy operations. ASA 1-2 80 subjects who is undergoing elective URS operations were enrolled in this prospective randomized clinical study. The demographic and airway characteristics of patients preoperatively and lam insertion times, nasogastric insertion times number of intubation attempts, fiberoptic grades from the lam, expired tidal volume, oropharyngeal leak pressures, peak and mean airway pressures preoperatively, minor complications like sore throat, hoarseness, dysphagia were recorded at the postoperative care unit.
- Conditions
- Ureteral Calculi
- Being tested
- proseal, baska-mask
- Keywords
- baska-mask, proseal, urs
- Medical subject headings
- Ureteral Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prosealDevice
Also called laryngeal mask
laryngeal mask proseal
baska-maskDevice
Also called laryngeal mask
laryngeal mask baska-mask
| Study group | Role | What they receive |
|---|---|---|
| insertion time | Active comparator | lma pro seal and basks-mask in patients undergoing ups Receives: Device: proseal; Device: baska-mask |
| oropharyngeal leak pressure | Active comparator | lma baska-mask undergoing urs Receives: Device: proseal; Device: baska-mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
insertion time
insertion time of the laryngeal mask
Measured: 20 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start5 Dec 2019
- Primary completion7 Feb 2022
- Study completion7 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ureteral CalculiStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zehra Ipek ARSLAN, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04186455
- Sponsor's protocol ID
- KAEK 2019/68
- Status last verified
- Feb 2022
- First submitted
- 28 Nov 2019
- Last updated
- 8 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pro Seal and Baska-mask
- ClinicalTrials.gov ID
- NCT04186455
- Acronym / sponsor ID
- KAEK 2019/68
- Conditions
- Ureteral Calculi
- Keywords
- baska-mask, proseal, urs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 5 Dec 2019 (actual)
- Primary completion
- 7 Feb 2022 (actual)
- Study completion
- 7 Feb 2022 (actual)
- First posted
- 4 Dec 2019 (actual)
- 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 use of Laryngeal masks are increased.This study aimed to compare lma pro seal and baska -mask in urethral retrograde sistoscopy operations.
Detailed description
The use of Laryngeal masks are increased. Aimed to compare lma pro seal and baska -mask in urologic retrograde sistoscopy operations. ASA 1-2 80 subjects who is undergoing elective URS operations were enrolled in this prospective randomized clinical study. The demographic and airway characteristics of patients preoperatively and lam insertion times, nasogastric insertion times number of intubation attempts, fiberoptic grades from the lam, expired tidal volume, oropharyngeal leak pressures, peak and mean airway pressures preoperatively, minor complications like sore throat, hoarseness, dysphagia were recorded at the postoperative care unit.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| insertion time | Active comparator | Device: proseal, Device: baska-masklma pro seal and basks-mask in patients undergoing ups |
| oropharyngeal leak pressure | Active comparator | Device: proseal, Device: baska-masklma baska-mask undergoing urs |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- undergoing elective urs operations
- bmı<35
- ASA I-II
Key exclusion criteria (2 listed)
- bmı>35
- ASA III-IV
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 |
|---|---|---|
| prosealAlso: laryngeal masklaryngeal mask proseal | Device | insertion time, oropharyngeal leak pressure |
| baska-maskAlso: laryngeal masklaryngeal mask baska-mask | Device | insertion time, oropharyngeal leak pressure |
Primary outcome
insertion time
Time frame: 20 seconds
insertion time of the laryngeal mask
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 8 Feb 2022.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing proseal and baska-mask in people with Ureteral Calculi, run by Kocaeli University 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 2 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 8 Feb 2022. 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?
insertion time (time frame: 20 seconds). 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 8 Feb 2022.