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

Sponsor

Medical University of Vienna (Other)

Overall Status

Completed

CT.gov ID

NCT03764319

Collaborator

(none)

Enrollment

Location

Arms

32.8

Actual Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
ARDS Acute Lung Injury Extracorporeal Membrane Oxygenation Respiratory Distress Syndrome Respiratory Tract Diseases Lung Diseases Lung Injury, Acute	Other: Ultra-protective ventilator settings Other: Standard ventilator settings	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Comparison of 2 groupsComparison of 2 groups

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Nov 6, 2018

Actual Primary Completion Date :

Aug 1, 2021

Actual Study Completion Date :

Aug 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Intervention group Ultra-protective ventilator settings in patients with ARDS and ECMO.	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)
Active Comparator: Control group Standard ventilator settings in patients with ARDS and ECMO.	Other: Standard ventilator settings 12-25 Breaths per minute; 8-12 cmH2O PEEP; max. 35 cmH2O Plateau pressure

Arm

Intervention/Treatment

Active Comparator: Intervention group

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

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)

Active Comparator: Control group

Standard ventilator settings in patients with ARDS and ECMO.

Other: Standard ventilator settings

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

Outcome Measures

Primary Outcome Measures

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

Total time of mechanical ventilation [Start of mechanical ventilation up to 28 days]
Total time of mechanical ventilation
28 day mortality [Immediately after initiation of ECMO up to 28 days]
Mortality from initiation of ECMO till day 28 after initiation of ECMO
One year mortality [Immediately after initiation of ECMO up to one year]
Mortality from initiation of ECMO till one year after initiation of ECMO
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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