RecruitingNot ApplicableNCT05562505

Trial of Venovenous ECMO to De-Sedate, Extubate and Mobilise in Hypoxic Respiratory Failure

A Randomised Controlled Trial of Venovenous ECMO to De-Sedate, Extubate and Mobilise in Hypoxic Respiratory Failure

Sponsor

Australian and New Zealand Intensive Care Research Centre

Enrollment

140 participants

Start Date

Nov 28, 2022

Study Type

INTERVENTIONAL

Conditions

COVID-19 Respiratory Infection Pneumonia Mechanical Ventilation Complication Hypoxemia Extracorporeal Membrane Oxygenation Acute Respiratory Distress Syndrome Due to COVID-19

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria5

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.
Trial of proning (unless contraindicated)

Exclusion Criteria14

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
Confirmed diffuse alveolar haemorrhage from vasculitis
Neurologic conditions, i.e. undergoing treatment for intracranial hypertension
Currently receiving any form of ECMO (e.g., venovenous, venoarterial, or hybrid configuration)
Patient needing immediate VV ECMO (as per EOLIA criteria)
The patient is moribund and deemed unlikely to survive past 24 hours (as determined by the clinical team)
The patient is being transitioned to palliative care
Contraindications to anticoagulation (e.g., active GI bleeding, bleeding predisposition, severe trauma)
Previous hypersensitivity/anaphylactic reaction to heparin or heparin-induced thrombocytopenia
Participation or Consent is declined, OR
Unable to identify or Contact surrogate decision maker.