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NCT01878552 Clinical Trial

Energy Load in Patients With Acute Respiratory Distress Syndrome (ARDS)

Acute Respiratory Distress Syndrome (ARDS) Clinical Trial

Official title:
Energy Load During Mechanical Ventilation in Patients With Acute Respiratory Distress Syndrome (ARDS)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01878552
Other study ID # Policlinico-07
Secondary ID
Status Completed
Phase N/A
First received June 7, 2013
Last updated April 27, 2015
Start date April 2013
Est. completion date August 2014

Study information
Verified date April 2015
Source Policlinico Hospital
Contact n/a
Is FDA regulated No
Health authority Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Study type Observational

Clinical Trial Summary

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

Description:

The investigator would study the inspiratory and expiratory pressure volume curve in ARDS patients and investigate if there is a correlation between the energy loss (hysteresis curve) and the severity of disease.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date August 2014
Est. primary completion date August 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- ARDS patients

Exclusion Criteria:

- pediatric population

- Chronic Obstructive Pulmonary Disease (COPD)

- patients with hemodynamic instability

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

  • Acute Lung Injury
  • Acute Respiratory Distress Syndrome (ARDS)
  • Respiratory Distress Syndrome, Adult
  • Respiratory Distress Syndrome, Newborn
  • Syndrome

Locations
Country Name City State
Italy Policlinico hospital Mialn

Sponsors (1)
Lead Sponsor Collaborator
Policlinico Hospital

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mortality Association between energy load provided to the lung during mechanical ventilation and mortality during ICU stay Two weeks (average ICU stay) Yes
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