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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-06

Study Completion Date

2021-08-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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ARDS Acute Lung Injury Extracorporeal Membrane Oxygenation Respiratory Distress Syndrome Respiratory Tract Diseases Lung Diseases Lung Injury, Acute

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Comparison of 2 groups

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention group

Ultra-protective ventilator settings in patients with ARDS and ECMO.

Group Type ACTIVE_COMPARATOR

Ultra-protective ventilator settings

Intervention Type 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)

Control group

Standard ventilator settings in patients with ARDS and ECMO.

Group Type ACTIVE_COMPARATOR

Standard ventilator settings

Intervention Type OTHER

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

Interventions

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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)

Intervention Type OTHER

Standard ventilator settings

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

Intervention Type OTHER

Eligibility Criteria

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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