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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00465374
Other study ID # PRN60ANRA04
Secondary ID
Status Recruiting
Phase Phase 3
First received April 24, 2007
Last updated April 24, 2007
Start date October 2002

Study information

Verified date April 2007
Source University of Turin, Italy
Contact V. M. Ranieri, MD
Phone 00390116334001
Email marco.ranieri@unito.it
Is FDA regulated No
Health authority Italy: Ministry of Health
Study type Interventional

Clinical Trial Summary

30% of ARDS patients ventilated according to NIH protocol presents CT scan evidence of hyperinflation. Functional analysis of pressure-time curve (Stress Index=SI) has been shown to identify this condition in experimental settings. We tested the hypothesis that the SI is an accurate predictor of mechanical stress due to overdistention in ARDS patients.


Description:

The study presents two parts : a preliminary validation study and a clinical study.


Recruitment information / eligibility

Status Recruiting
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria:

- Age = 18 years

- Diagnosis of ARDS based on American-European Consensus Conference criteria

Exclusion Criteria:

- >3 days since ARDS criteria were met and mechanical ventilation was started

- History of ventricular fibrillation or tachyarrhythmia, unstable angina or myocardial infarction within preceding month

- Pre-existing chronic obstructive pulmonary disease

- Major chest wall abnormalities

- Chest tube with persistent air leak

- Abdominal distension

- Body mass index >30

- Pregnancy

- Known intracranial abnormality

- Enrollment in another interventional study

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms

  • Acute Lung Injury
  • Respiratory Distress Syndrome, Adult
  • Respiratory Distress Syndrome, Newborn

Intervention

Procedure:
Change ventilatory parameters with stress index monitoring


Locations

Country Name City State
Italy University of Turin, Department of Anesthesia and Intensive Care Medicine Turin

Sponsors (1)

Lead Sponsor Collaborator
University of Turin, Italy

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Grasso S, Terragni P, Mascia L, Fanelli V, Quintel M, Herrmann P, Hedenstierna G, Slutsky AS, Ranieri VM. Airway pressure-time curve profile (stress index) detects tidal recruitment/hyperinflation in experimental acute lung injury. Crit Care Med. 2004 Apr;32(4):1018-27. — View Citation

Ranieri VM, Zhang H, Mascia L, Aubin M, Lin CY, Mullen JB, Grasso S, Binnie M, Volgyesi GA, Eng P, Slutsky AS. Pressure-time curve predicts minimally injurious ventilatory strategy in an isolated rat lung model. Anesthesiology. 2000 Nov;93(5):1320-8. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary reduction of pulmonary inflammatory mediators
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