NCT04186455

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 28, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 4, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

December 5, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2022

Completed
Last Updated

February 8, 2022

Status Verified

February 1, 2022

Enrollment Period

2.2 years

First QC Date

November 28, 2019

Last Update Submit

February 6, 2022

Conditions

Ureteral Calculi

Keywords

baska-maskprosealurs

Outcome Measures

Primary Outcomes (1)

  • insertion time

    insertion time of the laryngeal mask

    20 seconds

Study Arms (2)

insertion time

ACTIVE COMPARATOR

lma pro seal and basks-mask in patients undergoing ups

Device: prosealDevice: baska-mask

oropharyngeal leak pressure

ACTIVE COMPARATOR

lma baska-mask undergoing urs

Device: prosealDevice: baska-mask

Interventions

prosealDEVICE

laryngeal mask proseal

Also known as: laryngeal mask
insertion timeoropharyngeal leak pressure
baska-maskDEVICE

laryngeal mask baska-mask

Also known as: laryngeal mask
insertion timeoropharyngeal leak pressure

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • bmı\>35
  • ASA III-IV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli University Medical Faculty

Kocaeli, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Ureteral Calculi

Interventions

Laryngeal Masks

Condition Hierarchy (Ancestors)

UreterolithiasisUreteral DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Intubation, IntratrachealAirway ManagementTherapeuticsIntubationInvestigative TechniquesMasksProtective DevicesEquipment and SuppliesPersonal Protective EquipmentManufactured MaterialsTechnology, Industry, and Agriculture

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 28, 2019

First Posted

December 4, 2019

Study Start

December 5, 2019

Primary Completion

February 7, 2022

Study Completion

February 7, 2022

Last Updated

February 8, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)