Comparison of Laryngeal Masks in Urethral Cystoscopic Surgery Operations: a Prospective Randomized Clinical Study

NCT ID: NCT04186455

Last Updated: 2022-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-05

Study Completion Date

2022-02-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Ureteral Calculi

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

insertion time

lma pro seal and basks-mask in patients undergoing ups

Group Type ACTIVE_COMPARATOR

proseal

Intervention Type DEVICE

laryngeal mask proseal

baska-mask

Intervention Type DEVICE

laryngeal mask baska-mask

oropharyngeal leak pressure

lma baska-mask undergoing urs

Group Type ACTIVE_COMPARATOR

proseal

Intervention Type DEVICE

laryngeal mask proseal

baska-mask

Intervention Type DEVICE

laryngeal mask baska-mask

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

proseal

laryngeal mask proseal

Intervention Type DEVICE

baska-mask

laryngeal mask baska-mask

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

laryngeal mask laryngeal mask

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* undergoing elective urs operations
* bmı\<35
* ASA I-II

Exclusion Criteria

* bmı\>35
* ASA III-IV
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Kocaeli University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Zehra Ipek ARSLAN

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kocaeli University Medical Faculty

Kocaeli, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KAEK 2019/68

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.