NCT01878552

Brief Summary

The investigator would assess if there is an incremental energy load during mechanical ventilation in Acute Respiratory Distress Syndrome (ARDS) patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2013

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

April 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 7, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 17, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

April 28, 2015

Status Verified

April 1, 2015

Enrollment Period

1.3 years

First QC Date

June 7, 2013

Last Update Submit

April 27, 2015

Conditions

Acute Respiratory Distress Syndrome (ARDS)

Outcome Measures

Primary Outcomes (1)

  • Mortality

    Association between energy load provided to the lung during mechanical ventilation and mortality during ICU stay

    Two weeks (average ICU stay)

Study Arms (1)

ARDS

Mechanically ventilated patients with Acute Respiratory Distress Syndrome

Eligibility Criteria

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

ARDS patients

You may qualify if:

  • ARDS patients

You may not qualify if:

  • pediatric population
  • Chronic Obstructive Pulmonary Disease (COPD)
  • patients with hemodynamic instability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Policlinico hospital

Mialn, Italy, Italy

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

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

June 7, 2013

First Posted

June 17, 2013

Study Start

April 1, 2013

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

April 28, 2015

Record last verified: 2015-04

Locations

IT(1)