Low Dose Lung CT Scan for Quantitative Analysis in ARDS P... | NCT01926093

Studies
Low Dose Lung CT Scan for Quantitative Analysis in ARDS Patients

NCT01926093

Sponsor

Policlinico Hospital

Status

Completed

Last Update Posted

Jan 9, 2014Estimated

Enrollment

51Actual

Phase

Not provided

Conditions

Acute Respiratory Distress Syndrome (ARDS)

Interventions

Not provided

Countries

Italy

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

ID	Type	Description	Link
3102-28/12/2012

Status Module

Record Verification Date

Aug 2013

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

Jun 2012

Primary Completion Date

May 2013Actual

Completion Date

May 2013Actual

First Submitted Date

Aug 13, 2013

First Submission Date that Met QC Criteria

Aug 16, 2013

First Posted Date

Aug 20, 2013Estimated

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 8, 2014

Last Update Posted Date

Jan 9, 2014Estimated

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

We aimed to assess the accuracy of visual and quantitative analysis performed on low radiation dose lung CT scan (30-60 mAs)compared with that performed on standard radiation dose lung CT scan (110 mAs), in ARDS patients. If the results in computing lung recruitment will be similar, we will be able to use Low Dose CT scan for monitoring of the evolution of the disease in ARDS patients.

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

51Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Difference between Standard and Low Dose lung CT scan in visual and quantitative analysis	We measured lung recruitment with visual and quantitative analysis both on standard and low dose CT scan.	1 day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Acute Respiratory Distress Syndrome
CT scan performed for clinical purposes

Exclusion Criteria:

Age < 18 years
hemodynamic instability

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

ARDS patients fulfilling the Berlin definition criteria

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Davide Chiumello, MD	IRCCS Ca' Granda - Ospedale MAggiore Policlinico	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
IRCCS Ca' Granda - Ospedale MAggiore Policlinico		Milan		20122	Italy

Condition Browse Module

MeSH Terms

ID	Term
D012128	Respiratory Distress Syndrome

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D012120	Respiration Disorders

Browse Leaves

Not provided

Browse Branches

Not provided