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NCT Number: NCT03764319

Low Frequency, Ultra-low Tidal Volume Ventilation in Patients With ARDS and ECMO

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.

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Key information

Conditions

ARDS Acute Lung Injury Extracorporeal Membrane Oxygenation Lung Diseases Lung Injury Lung Injury, Acute Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Distress Syndrome Respiratory Tract Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Vienna - Division of General Anaesthesia and Intensive Care Medicine

Vienna, Austria, 1090

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultra-protective ventilator settings

Other

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

Other

12-25 Breaths per minute; 8-12 cmH2O PEEP; max. 35 cmH2O Plateau pressure

Primary outcomes

  1. Ventilator free days

    Time frame: Immediately after initiation of ECMO up to 28 days

    Ventilator free days

  2. Time from randomization to fulfillment of extubation criteria

    Time frame: Immediately after initiation of ECMO up to 28 days

    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

Secondary outcomes

  1. Total time of mechanical ventilation

    Time frame: Start of mechanical ventilation up to 28 days

    Total time of mechanical ventilation

  2. 28 day mortality

    Time frame: Immediately after initiation of ECMO up to 28 days

    Mortality from initiation of ECMO till day 28 after initiation of ECMO

  3. One year mortality

    Time frame: Immediately after initiation of ECMO up to one year

    Mortality from initiation of ECMO till one year after initiation of ECMO

  4. Incidence of reintubation

    Time frame: Immediately after initiation of ECMO up to 28 days

    Incidence of reintubation

  5. Length of ICU stay

    Time frame: Immediately after initiation of ECMO

    Length of ICU stay

  6. Evaluation of RAS, ACE, ACE2.

    Time frame: 2 months

    Analyses of leftover blood. Renin angiotensin system (RAS) and Angiotensin converting enzyme (ACE) evaluation.

  7. Evaluation of Cytokines in pg/ml

    Time frame: 2 months

    IL-6, IL-8, TNFR1, RAGE, Protein C

  8. Evaluation of vitamin D status

    Time frame: Length of ICU stay

    25(OH), 1,25(OH)

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Dec 5, 2018
Registry last updated
Apr 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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