NCT02000791

Brief Summary

it is compared that laryngeal mask insertion with standard technique and laryngoscopic technique

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2013

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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 21, 2013

Completed
10 days until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 4, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

December 4, 2013

Status Verified

November 1, 2013

Enrollment Period

2 months

First QC Date

November 21, 2013

Last Update Submit

December 3, 2013

Conditions

Urologic Surgery

Keywords

cLMAlaryngoscopyfiberoptic

Outcome Measures

Primary Outcomes (1)

  • İnvestigate to easy of insertion whether standart or laryngoscopic technique

    1 min after insertion

Secondary Outcomes (1)

  • Fiberoptic view

    1 min after insertion

Study Arms (2)

cLMA insertion via laryngoscopic technique

EXPERIMENTAL

Comparison of cLMA insertion via laryngoscope view by fiberscope

Other: Comparison of fibreoptic view

cLMA insertion via standart technique

ACTIVE COMPARATOR

Comparison of cLMA insertion via standart technique view by fiberscope

Other: Comparison of fibreoptic view

Interventions

Comparison of fibreoptic viewOTHER
cLMA insertion via laryngoscopic techniquecLMA insertion via standart technique

Eligibility Criteria

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

You may qualify if:

  • Over 18 age
  • under urologic surgery patient

You may not qualify if:

  • Uper respiratory infection
  • Full stomach
  • BMI over 40

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diskapi Yildiim Beyazit Eduation and Research Hospital

Ankara, Turkey (Türkiye)

Location

Study Officials

  • Tugba Arslan, MD

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tuğba Arslan, MD

CONTACT

+905074378919tuba.kokulu@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
medical doctor

Study Record Dates

First Submitted

November 21, 2013

First Posted

December 4, 2013

Study Start

December 1, 2013

Primary Completion

February 1, 2014

Study Completion

May 1, 2014

Last Updated

December 4, 2013

Record last verified: 2013-11

Locations

TU(1)