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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03764319
Other study ID # MUVienna ARDS-ECMO
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 6, 2018
Est. completion date August 1, 2021

Study information

Verified date September 2021
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

The aim of this study is to assess the effect of a rigorous low breathing frequency and ultra-low tidal volume ventilation strategy on clinical outcome, compared to standard ventilator settings following the recent guidelines in patients with severe ARDS treated with ECMO. The hypothesis is that a low breathing frequency and ultra-low tidal volume ventilation strategy is more protective for the ARDS challenged lung and reduces the duration of mechanical ventilation and so increases the ventilator free days in patients with severe ARDS treated with ECMO.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Ultra-protective ventilator settings
4-5 Breaths per minute; 14-16 cmH2O Positive endexpiratory pressure (PEEP) (adjust PEEP to 23 < Plateau pressure < 25 cmH2O); 23-25 cmH2O Plateau pressure (adjust to not exceed Tidal volume > 4 mL/kg Predicted body weight (PBW)); < 4mL/kg PBW Tidal volume; 1:5 Inspiration:Expiration (I:E)
Standard ventilator settings
12-25 Breaths per minute; 8-12 cmH2O PEEP; max. 35 cmH2O Plateau pressure

Locations

Country Name City State
Austria Medical University of Vienna - Division of General Anaesthesia and Intensive Care Medicine Vienna

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

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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