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

Lung Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03764319
• Other study ID #: MUVienna ARDS-ECMO
• Status: Completed
• Phase: N/A
• Start date: November 6, 2018
• Est. completion date: August 1, 2021

Study information

• Verified date: September 2021
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: August 1, 2021
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• ARDS
• Extracorporeal Membrane Oxygenation
• Lung Diseases
• Lung Injury
• Lung Injury, Acute
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Respiratory Tract Diseases
• Wounds and Injuries

Intervention

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)
• Standard ventilator settings
12-25 Breaths per minute; 8-12 cmH2O PEEP; max. 35 cmH2O Plateau pressure

Locations

Country	Name	City	State
Austria	Medical University of Vienna - Division of General Anaesthesia and Intensive Care Medicine	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ventilator free days	Ventilator free days	Immediately after initiation of ECMO up to 28 days
Primary	Time from randomization to fulfillment of extubation criteria	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	Immediately after initiation of ECMO up to 28 days
Secondary	Total time of mechanical ventilation	Total time of mechanical ventilation	Start of mechanical ventilation up to 28 days
Secondary	28 day mortality	Mortality from initiation of ECMO till day 28 after initiation of ECMO	Immediately after initiation of ECMO up to 28 days
Secondary	One year mortality	Mortality from initiation of ECMO till one year after initiation of ECMO	Immediately after initiation of ECMO up to one year
Secondary	Incidence of reintubation	Incidence of reintubation	Immediately after initiation of ECMO up to 28 days
Secondary	Length of ICU stay	Length of ICU stay	Immediately after initiation of ECMO
Secondary	Evaluation of RAS, ACE, ACE2.	Analyses of leftover blood. Renin angiotensin system (RAS) and Angiotensin converting enzyme (ACE) evaluation.	2 months
Secondary	Evaluation of Cytokines in pg/ml	IL-6, IL-8, TNFR1, RAGE, Protein C	2 months