Status:
UNKNOWN
Assisted or Controlled Ventilation in Ards (Ascovent)
Lead Sponsor:
University of Roma La Sapienza
Conditions:
ARDS
Ventilator-Induced Lung Injury
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The present pilot randomized controlled clinical trial will test the hypothesis that in patients with ARDS, fixing ventilator settings to the conventional protective ventilatory strategy (VT 6 ml/kg i...
Detailed Description
All patients will be treated according to the sedation protocols and standards of care. Sedation will be guaranteed by continuous infusion of Propofol 2-4 ml / Kg / h, Remifentanil 0.05-0.1 mcg / Kg /...
Eligibility Criteria
Inclusion
- Patients \> 18 years of age who:
- Are intubated less than 24 hours since meeting the Berlin definition criteria for ARDS.
- Have a commitment to full support;
- Have no exclusion criteria
Exclusion
- Intubation and mechanical ventilation (any form) for \> 24 hours;
- Acute brain injury with Glasgow coma scale (GCS) \<7;
- Body mass index \> 40;
- Age \< 18 years;
- Neuromuscular disease that impairs ability to ventilate without assistance;
- Severe chronic respiratory disease;
- Burns \> 40% total body surface area;
- Malignancy or other irreversible disease or condition for which 6-month mortality is estimated to be greater than 50%;
- Allogeneic bone marrow transplant within the last 5 years;
- Chronic respiratory condition making patient respirator dependent;
- Patient, surrogate, or physician not committed to full support;
- Acute myocardial infarction or acute coronary syndrome within 30 days;
- Moribund patient: not expected to survive 24 hours;
- No consent/inability to obtain consent
Key Trial Info
Start Date :
September 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2019
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03245684
Start Date
September 1 2017
End Date
September 1 2019
Last Update
August 10 2017
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