To determine whether a strategy of adding venovenous ECMO to mechanical ventilation, as compared to mechanical ventilation alone, increases the number of intensive care free days at day 60, in patients with moderate to severe acute hypoxic respiratory failure.
Patients ≥18 to 65 years old
Acute hypoxemic respiratory failure characterised by new or worsening respiratory symptoms developing within 2 weeks prior to the onset of need for oxygen or respiratory support
Mechanical ventilation of <7 days
Moderate to severe respiratory failure, as demonstrated by two P:F ratios <150mmHg at least 6 hours apart. Arterial Blood Gases (ABG) with P:F ratio > 150mmHg are permitted between the two trial inclusion ABGs.
The patient will be extubated today or tomorrow (i.e. will not remain intubated and ventilated the day after tomorrow)
Cardiogenic cause of respiratory failure
Chronic hypercapnic respiratory failure defined as PaCO2 > 60 mmHg in the outpatient setting
Home mechanical ventilation (non-invasive ventilation or via tracheotomy) except for CPAP/BIPAP used solely for sleep disordered breathing
Parallel
Venovenous ECMO
Other interventionECMO therapy for patients with hypoxic respiratory failure.
Intensive Care Unit Free days to Day 60
Days alive and free from ICU to Day 60. Day Day 0 is randomisation day, with any portion of a day is spent in an ICU counted as a day.
Daily sedation scores
Highest (+4 Combative) and lowest (-5 Unarousable) daily Richmond Agitation and Sedation Scores (RASS). The optimal score for early mobilisation of participants on ECMO is 0 Alert and Calm.
Extubation rates
Date and time of enduring extubation
Participation in early mobilisation
Daily assessment for mobilisation by allied health clinicians using the ICU Mobility Scale. The ICU Mobility Scale ranges from 0-Lying in Bed, to 10-Walking Independently without a Gait Aid. Score 7-Walking With the Assistance of 2 or More People is the best outcome achievable for participants on ECMO.
Number of Participants who were randomised to standard care initially and subsequently needed VV-ECMO.
Number of Participants who were randomised to standard care initially and subsequently needed VV-ECMO.
WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)
Assessment of 6 domains of functioning for participants at Day 180 follow up via telephone interview. Total possible scores are 48. A lower score indicates a better outcome.
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Australian and New Zealand Intensive Care Research Centre
Lead sponsor
The Alfred
Collaborator
