NCT01826565

Brief Summary

To evaluate the efficacy of rotational technique in the insertion of i-gel

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable prostate-cancer

Timeline
Completed

Started May 2013

Shorter than P25 for not_applicable prostate-cancer

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

March 19, 2013

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 8, 2013

Completed
23 days until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

May 6, 2013

Status Verified

May 1, 2013

Enrollment Period

1 year

First QC Date

March 19, 2013

Last Update Submit

May 3, 2013

Conditions

Prostate CancerProstate TumorBladder CancerBladder Tumor

Keywords

success

Outcome Measures

Primary Outcomes (1)

  • The success rate of insertion

    check oropharyngeal leakage at pressure 12 cmH2O

    up to 30 min.

Secondary Outcomes (1)

  • postoperative sore throat

    up to 2 days

Study Arms (2)

Control

NO INTERVENTION

i-gel will be inserted without rotation

Rotation

EXPERIMENTAL

Rotational technique applied

Procedure: Rotational technique

Interventions

Rotational techniquePROCEDURE

90 degree rotation

Also known as: 90 degree rotation technique
Rotation

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Patients scheduled for general anesthesia(transurethral resection of bladder tumor or transurethral resection of the prostate) using i-gelTM

You may not qualify if:

  • History of recent postoperative sore throat
  • History of difficult airway
  • Mouth opening \< 2.5 cm
  • Emergency operation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Prostatic NeoplasmsUrinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesUrologic NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrinary Bladder DiseasesUrologic Diseases

Study Officials

  • Hee-Pyung Park, MD PhD

    Seoul National University of Hospital

    PRINCIPAL INVESTIGATOR

  • Hyun-Chang Kim, MD

    Seoul National University of Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2013

First Posted

April 8, 2013

Study Start

May 1, 2013

Primary Completion

May 1, 2014

Study Completion

July 1, 2014

Last Updated

May 6, 2013

Record last verified: 2013-05