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

Primary Purpose

Ureteral Calculi

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
proseal
baska-mask
Sponsored by
Kirsehir Ahi Evran University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ureteral Calculi focused on measuring baska-mask, proseal, urs

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kocaeli University Medical Faculty

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

insertion time

oropharyngeal leak pressure

Arm Description

lma pro seal and basks-mask in patients undergoing ups

lma baska-mask undergoing urs

Outcomes

Primary Outcome Measures

insertion time
insertion time of the laryngeal mask

Secondary Outcome Measures

Full Information

First Posted
November 28, 2019
Last Updated
February 6, 2022
Sponsor
Kirsehir Ahi Evran University
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1. Study Identification

Unique Protocol Identification Number
NCT04186455
Brief Title
Comparison of Laryngeal Masks in Urethral Cystoscopic Surgery Operations: a Prospective Randomized Clinical Study
Official Title
Comparison of Pro Seal and Baska-mask
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
December 5, 2019 (Actual)
Primary Completion Date
February 7, 2022 (Actual)
Study Completion Date
February 7, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kirsehir Ahi Evran University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ureteral Calculi
Keywords
baska-mask, proseal, urs

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
insertion time
Arm Type
Active Comparator
Arm Description
lma pro seal and basks-mask in patients undergoing ups
Arm Title
oropharyngeal leak pressure
Arm Type
Active Comparator
Arm Description
lma baska-mask undergoing urs
Intervention Type
Device
Intervention Name(s)
proseal
Other Intervention Name(s)
laryngeal mask
Intervention Description
laryngeal mask proseal
Intervention Type
Device
Intervention Name(s)
baska-mask
Other Intervention Name(s)
laryngeal mask
Intervention Description
laryngeal mask baska-mask
Primary Outcome Measure Information:
Title
insertion time
Description
insertion time of the laryngeal mask
Time Frame
20 seconds

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Kocaeli University Medical Faculty
City
Kocaeli
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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