NCT02501577

Brief Summary

Placement of a supraglottic airway device Fiberoptical verification of pharyngeal position

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
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2015

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

March 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 9, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 17, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

July 17, 2015

Status Verified

July 1, 2015

Enrollment Period

7 months

First QC Date

July 9, 2015

Last Update Submit

July 16, 2015

Conditions

Intubation; Difficult

Outcome Measures

Primary Outcomes (1)

  • Visibility of vocal cords

    intraoperative

Study Arms (2)

SAD 1

EXPERIMENTAL

FOI for placement

Device: SAD 1

SAD 2

EXPERIMENTAL

FOI für placement

Device: SAD 2

Interventions

SAD 1DEVICE

Placement and fiberoptic control

SAD 1
SAD 2DEVICE

Placement and fiberoptic control

SAD 2

Eligibility Criteria

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

You may qualify if:

  • will to participate

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Regensburg

Regensburg, 93051, Germany

RECRUITING

Study Officials

  • Thomas Metterlein, MD

    Uni Regensburg

    STUDY CHAIR

Central Study Contacts

Thomas Metterlein, MD

CONTACT

+499419440thomas.metterlein@ukr.de

Christoph Plank, MD

CONTACT

+499419440christop.plank@ukr.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 9, 2015

First Posted

July 17, 2015

Study Start

March 1, 2015

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

July 17, 2015

Record last verified: 2015-07

Locations

DE(1)