NCT01876836

Brief Summary

  1. 1.i-gel
  2. 2.C-LMA

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
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2013

Shorter than P25 for phase_4

Geographic Reach
1 country

2 active sites

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

June 10, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 13, 2013

Completed
18 days until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

June 13, 2013

Status Verified

June 1, 2013

Enrollment Period

1 month

First QC Date

June 10, 2013

Last Update Submit

June 11, 2013

Conditions

Bladder TumourProstate Hyperplasia

Keywords

i-gelC-LMAgastroeosephageal refluxsore troat

Outcome Measures

Primary Outcomes (1)

  • Ph MEASUREMENT

    The ph of the secretions on the airway device will be measurd with a Ph-meter

    1 MİNUTE AFTER EXTUBATİON

Secondary Outcomes (1)

  • Bleu dye on the airway device

    5 min after placenent

Other Outcomes (1)

  • Blue dye on airway device

    1 min after extubation

Study Arms (2)

i-gel

EXPERIMENTAL

i-gel placed after induction

Device: i-gel

C-LMA

ACTIVE COMPARATOR

C-LMA placed after induction

Device: C-LMA

Interventions

i-gelDEVICE

i-gel placed after induction

Also known as: supraglottic airway device
i-gel
C-LMADEVICE

placed after induction

Also known as: supraglottic airway device
C-LMA

Eligibility Criteria

Age19 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA I-II
  • Adult
  • Elective surgery
  • Bladder tumour
  • Prostat hyperplasi

You may not qualify if:

  • Emergency surgery
  • Hiatal hernia
  • Gastroeosephageal reflux disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

DiskapiYBERH

Ankara, Altındağ, 06610, Turkey (Türkiye)

Location

DiskapiYBERH

Ankara, Altındağ, 06610, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urinary Bladder NeoplasmsProstatic Hyperplasia

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesProstatic DiseasesGenital Diseases, MaleGenital Diseases

Study Officials

  • Reyhan Polat, MD

    Diskapi Yildirim Beyazit Education and Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Reyhan Polat, MD

CONTACT

+905326734310reyhanp9@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

June 10, 2013

First Posted

June 13, 2013

Study Start

July 1, 2013

Primary Completion

August 1, 2013

Study Completion

September 1, 2013

Last Updated

June 13, 2013

Record last verified: 2013-06

Locations

TU(2)