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

Sponsor
Kocaeli University (Other)
Overall Status
Completed
CT.gov ID
NCT04186455
Collaborator
(none)
64
Enrollment
1
Location
2
Arms
26.1
Actual Duration (Months)
2.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: proseal
  • Device: baska-mask
 N/A

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

Study Type:
Interventional
Actual Enrollment :
64 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Diagnostic
Official Title:
Comparison of Pro Seal and Baska-mask
Actual Study Start Date :
Dec 5, 2019
Actual Primary Completion Date :
Feb 7, 2022
Actual Study Completion Date :
Feb 7, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. insertion time [20 seconds]

      insertion time of the laryngeal mask

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kocaeli University Medical Faculty Kocaeli Turkey

    Sponsors and Collaborators

    • Kocaeli University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zehra Ipek ARSLAN, Associate Professor, Kocaeli University
    ClinicalTrials.gov Identifier:
    NCT04186455
    Other Study ID Numbers:
    • KAEK 2019/68
    First Posted:
    Dec 4, 2019
    Last Update Posted:
    Feb 8, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Zehra Ipek ARSLAN, Associate Professor, Kocaeli University
    baska-mask
    proseal
    urs
    Additional relevant MeSH terms:
    Ureteral Calculi
    Ureterolithiasis
    Calculi

    Study Results

    No Results Posted as of Feb 8, 2022