NCT01926093

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

June 1, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 13, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 20, 2013

Completed
Last Updated

January 9, 2014

Status Verified

August 1, 2013

Enrollment Period

11 months

First QC Date

August 13, 2013

Last Update Submit

January 8, 2014

Conditions

Acute Respiratory Distress Syndrome (ARDS)

Keywords

Acute Respiratory Distress Syndrome (ARDS)

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

ARDS patients fulfilling the Berlin definition criteria

You may qualify if:

  • Acute Respiratory Distress Syndrome
  • CT scan performed for clinical purposes

You may not qualify if:

  • Age \< 18 years
  • hemodynamic instability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Ca' Granda - Ospedale MAggiore Policlinico

Milan, 20122, Italy

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • Davide Chiumello, MD

    IRCCS Ca' Granda - Ospedale MAggiore Policlinico

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 13, 2013

First Posted

August 20, 2013

Study Start

June 1, 2012

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

January 9, 2014

Record last verified: 2013-08

Locations

IT(1)