Predictors for Bronchoalveolar Lavage (BAL) Recovery Rate... | NCT03388580

Studies
Predictors for Bronchoalveolar Lavage (BAL) Recovery Rate Derived From Quantified Computed Tomography (qCT)

NCT03388580

Sponsor

Universitätsmedizin Mannheim

Status

Completed

Last Update Posted

Jan 4, 2018Actual

Enrollment

33Actual

Phase

Not provided

Conditions

Interstitial Lung Disease
Pneumonia
Malignant Neoplasm

Interventions

bronchoalveolar lavage (BAL)

Countries

Not provided

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

Jan 2018

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

Jan 2017Actual

Primary Completion Date

Sep 2017Actual

Completion Date

Sep 2017Actual

First Submitted Date

Dec 24, 2017

First Submission Date that Met QC Criteria

Dec 24, 2017

First Posted Date

Jan 3, 2018Actual

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

Jan 2, 2018

Last Update Posted Date

Jan 4, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Frederik Trinkmann, Principal Investigator, Universitätsmedizin MannheimPrincipal Investigator

Lead Sponsor

Universitätsmedizin MannheimOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

Bronchoalveolar lavage (BAL) is an important diagnostic method. The percentage of fluid extracted after instillation (recovery rate) is crucial for following diagnostic tests. The investigators aimed to compare novel quantified airway parameters from pre-interventional lung computed tomography (CT) with recovery rates to find possible predictive markers.

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

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

33Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BAL		patients undergoing elective bronchoalveolar lavage	Procedure: bronchoalveolar lavage (BAL)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
bronchoalveolar lavage (BAL)	Procedure	clinically indicated, elective BAL	BAL

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
recovery rate	volume of recovered volume	30 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

retrospective analysis of all patients undergoing BAL and complete documentation

Exclusion Criteria:

incomplete documentation

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

Patients undergoing elective BAL with clinical indication.

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D017563	Lung Diseases, Interstitial
D011014	Pneumonia
D009369	Neoplasms

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D018893	Bronchoalveolar Lavage

Ancestor Terms

ID	Term
D007507	Therapeutic Irrigation
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided