Examination of Double-Lumen Tube Placement by Functional... | NCT00486616

Studies
Examination of Double-Lumen Tube Placement by Functional Electrical Impedance Tomography

NCT00486616

Sponsor

University Hospital Freiburg

Status

Completed

Last Update Posted

Feb 18, 2008Estimated

Enrollment

Not provided

Phase

Not provided

Conditions

Double-Lumen Tube Placement
One-Lung Ventilation

Interventions

electrical impedance tomography
double-lumen tube placement

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2007

Primary Completion Date

Aug 2007Actual

Completion Date

Aug 2007Actual

First Submitted Date

Jun 13, 2007

First Submission Date that Met QC Criteria

Jun 13, 2007

First Posted Date

Jun 14, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 11, 2008

Last Update Posted Date

Feb 18, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine whether functional electrical impedance tomography is suitable for examination of double-lumen tube placement compared with fibreoptic evaluation.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

consent of the patient
intubation with left- or right-sided double-lumen tube
age >= 18 years

Exclusion Criteria:

refusal by the patient
contraindications for EIT-measurement (e.g. pacemaker, pregnancy)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Daniel Steinmann, MD	Department of Anesthesia and Critical Care Medicine, University Hospital Freiburg	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Freiburg		Freiburg im Breisgau		79106	Germany

Name	Type	Description	Arm Group Labels	Other Names
electrical impedance tomography	Device
double-lumen tube placement	Procedure