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

February 6, 2022 updated by: Zehra Ipek ARSLAN, Kocaeli University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Kocaeli, Turkey
        • Kocaeli University Medical Faculty

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:18-65 years of age

  • undergoing elective urs operations
  • bmı<35
  • ASA I-II

Exclusion Criteria:<18 years of age

  • bmı>35
  • ASA III-IV

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: insertion time
lma pro seal and basks-mask in patients undergoing ups
Device: proseal
laryngeal mask proseal
Other Names:
  • laryngeal mask
Device: baska-mask
laryngeal mask baska-mask
Other Names:
  • laryngeal mask
Active Comparator: oropharyngeal leak pressure
lma baska-mask undergoing urs
Device: proseal
laryngeal mask proseal
Other Names:
  • laryngeal mask
Device: baska-mask
laryngeal mask baska-mask
Other Names:
  • laryngeal mask

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
insertion time
Time Frame: 20 seconds
insertion time of the laryngeal mask
20 seconds

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kocaeli University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2019

Primary Completion (Actual)

February 7, 2022

Study Completion (Actual)

February 7, 2022

Study Registration Dates

First Submitted

November 28, 2019

First Submitted That Met QC Criteria

December 2, 2019

First Posted (Actual)

December 4, 2019

Study Record Updates

Last Update Posted (Actual)

February 8, 2022

Last Update Submitted That Met QC Criteria

February 6, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KAEK 2019/68

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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