Clinical trial NCT03764319: Low Frequency, Ultra-low Tidal Volume Ventilation in Patients With ARDS and ECMO
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ARDS
Acute Lung Injury
Extracorporeal Membrane Oxygenation
Respiratory Distress Syndrome
Respiratory Tract Diseases
Lung Diseases
Lung Injury, Acute
Keywords: ARDS, ECMO, Ventilation
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2018-12-05
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparison of 2 groups
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Ventilator free days
timeFrame: Immediately after initiation of ECMO up to 28 days
measure: Time from randomization to fulfillment of extubation criteria
timeFrame: Immediately after initiation of ECMO up to 28 days
Secondary outcomes:
measure: Total time of mechanical ventilation
timeFrame: Start of mechanical ventilation up to 28 days
measure: 28 day mortality
timeFrame: Immediately after initiation of ECMO up to 28 days
measure: One year mortality
timeFrame: Immediately after initiation of ECMO up to one year
measure: Incidence of reintubation
timeFrame: Immediately after initiation of ECMO up to 28 days
measure: Length of ICU stay
timeFrame: Immediately after initiation of ECMO
measure: Evaluation of RAS, ACE, ACE2.
timeFrame: 2 months
measure: Evaluation of Cytokines in pg/ml
timeFrame: 2 months
measure: Evaluation of vitamin D status
timeFrame: Length of ICU stay
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna - Division of General Anaesthesia and Intensive Care Medicine
Study officials:
affiliation: Department of Anesthesia and Intensive Care
name: Roman Ullrich, Ao.Univ.Prof.
role: PRINCIPAL_INVESTIGATOR
References: