Lung Diseases Clinical Trial
Official title:
Low Frequency, Ultra-low Tidal Volume Ventilation in Patients With Severe Acute Respiratory Distress Syndrome and Extracorporeal Membrane Oxygenation: a Prospective, Randomized, Clinical Trial
Verified date | September 2021 |
Source | Medical University of Vienna |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The acute respiratory distress syndrome (ARDS) is the most severe form of respiratory failure, presented in 10% of all intensive care patients and carrying a high mortality rate. Extracorporeal membrane oxygenation (ECMO) is a rescue treatment for patients with severe ARDS. Mechanical ventilator settings in patients with severe ARDS during ECMO therapy are not clearly defined at the moment.
Status | Completed |
Enrollment | 44 |
Est. completion date | August 1, 2021 |
Est. primary completion date | August 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | Inclusion Criteria: - Moderate to severe ARDS - Partial pressure of oxygen/Fraction of inspired oxygen (PaO2/FiO2) < 200 mmHg - ECMO < 24 hours in situ - Gender-matched - Age-matched Exclusion Criteria: - BMI > 40 - Expected weaning of ECMO < 3 days (postoperative ECMO) - Combustion - Restrictive chest wall impairment - Pregnancy |
Country | Name | City | State |
---|---|---|---|
Austria | Medical University of Vienna - Division of General Anaesthesia and Intensive Care Medicine | Vienna |
Lead Sponsor | Collaborator |
---|---|
Medical University of Vienna |
Austria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ventilator free days | Ventilator free days | Immediately after initiation of ECMO up to 28 days | |
Primary | Time from randomization to fulfillment of extubation criteria | Time from randomization (initiation of ECMO) to fulfillment of the extubation criteria:
ARDS resolved Temperature = 36°C and = 39°C Low FiO2 (< 0.5) PEEP (< 8 cmH2O) requirement Able to initiate spontaneous breaths Tidalvolume > 5 mL/kg or > 325 mL Minute ventilation 5-6 L/min PaO2/FiO2 > 200 mmHg pH = 7.25 Ability to cough after deflating tube cuff Respiratory rate 8-30/min Hemodynamic stability |
Immediately after initiation of ECMO up to 28 days | |
Secondary | Total time of mechanical ventilation | Total time of mechanical ventilation | Start of mechanical ventilation up to 28 days | |
Secondary | 28 day mortality | Mortality from initiation of ECMO till day 28 after initiation of ECMO | Immediately after initiation of ECMO up to 28 days | |
Secondary | One year mortality | Mortality from initiation of ECMO till one year after initiation of ECMO | Immediately after initiation of ECMO up to one year | |
Secondary | Incidence of reintubation | Incidence of reintubation | Immediately after initiation of ECMO up to 28 days | |
Secondary | Length of ICU stay | Length of ICU stay | Immediately after initiation of ECMO | |
Secondary | Evaluation of RAS, ACE, ACE2. | Analyses of leftover blood. Renin angiotensin system (RAS) and Angiotensin converting enzyme (ACE) evaluation. | 2 months | |
Secondary | Evaluation of Cytokines in pg/ml | IL-6, IL-8, TNFR1, RAGE, Protein C | 2 months |
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