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

Not Applicable

Completed

• Conditions: ARDS; Acute Lung Injury; Lung Injury, Acute; Respiratory Distress Syndrome; Extracorporeal Membrane Oxygenation; Lung Diseases; Respiratory Tract Diseases
• Interventions: Other: Standard ventilator settings; Other: Ultra-protective ventilator settings

• Registration Number: NCT03764319
• Lead Sponsor: Medical University of Vienna

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.

Study Timeline

• Study Start: 2018-11-06
• Study First Submitted: 2018-11-29
• Study First Submitted QC: 2018-12-04
• Study First Posted: 2018-12-05
• Primary Completion: 2021-08-01
• Study Completion: 2021-08-01
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-13
• Last Update Posted: 2021-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

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Exclusion Criteria

• BMI > 40
• Expected weaning of ECMO < 3 days (postoperative ECMO)
• Combustion
• Restrictive chest wall impairment
• Pregnancy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Standard ventilator settings	Standard ventilator settings in patients with ARDS and ECMO.
Intervention group	Ultra-protective ventilator settings	Ultra-protective ventilator settings in patients with ARDS and ECMO.

Primary Outcome Measures

Name	Time	Method
Ventilator free days	Immediately after initiation of ECMO up to 28 days	Ventilator free days
Time from randomization to fulfillment of extubation criteria	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 Outcome Measures

Name	Time	Method
28 day mortality	Immediately after initiation of ECMO up to 28 days	Mortality from initiation of ECMO till day 28 after initiation of ECMO
Total time of mechanical ventilation	Start of mechanical ventilation up to 28 days	Total time of mechanical ventilation
Incidence of reintubation	Immediately after initiation of ECMO up to 28 days	Incidence of reintubation
Length of ICU stay	Immediately after initiation of ECMO	Length of ICU stay
Evaluation of RAS, ACE, ACE2.	2 months	Analyses of leftover blood. Renin angiotensin system (RAS) and Angiotensin converting enzyme (ACE) evaluation.
Evaluation of Cytokines in pg/ml	2 months	IL-6, IL-8, TNFR1, RAGE, Protein C
One year mortality	Immediately after initiation of ECMO up to one year	Mortality from initiation of ECMO till one year after initiation of ECMO

Trial Locations

Locations (1)

Medical University of Vienna - Division of General Anaesthesia and Intensive Care Medicine; 🇦🇹 Vienna, Austria