PRotective vEntilation with veno-venouS lung assisT in respiratory failure

Belfast Health & Social Care Trust0 sites412 target enrollmentApril 14, 2016

Overview

2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34463700/ (added 20/05/2022) 2023 Other publications in https://doi.org/10.3310/fcdq8036 cost-utility analysis (added 17/10/2023)

Registry

who.int

Start Date

April 14, 2016

End Date

April 30, 2022

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

•1\. Invasive mechanical ventilation using PEEP \= 5cmH2O\*
•2\. Acute and potentially reversible cause of acute respiratory failure as determined by the treating physician
•3\. Within 48 hours of the onset of hypoxaemia as defined by PaO2/FiO2 \= 20kPa\*\*
•\*Recommended on low tidal volume ventilation \= 6 ml/kg PBW
•\*\*Requires two ABG with a PaO2/FiO2 \= 20kPa separated by at least 6 hours. 48 hour duration begins at the time of 2nd ABG demonstrating PaO2/FiO2 ratio \= 20kPa. Added 05/03/2019: Site will then have a further 8 – 24 hours to randomise and administer the intervention. Added 23/05/2017: The onset of hypoxaemia is from time of intubation and invasive ventilation.
•(ABGs with PaO2/FiO2 \= 20kPa are permitted between the two trial inclusion ABGs).

•Current exclusion criteria as of 23/05/2017:
•1\. Age \<16 years old
•2\. Intubated and mechanically ventilated via an endotracheal or tracheostomy tube \= 7 days (168 hours) up to the time of randomisation
•3\. Ability to maintain Vt to \= 3ml/kg PBW while maintaining pH \= 7\.2 as determined by the treating physician
•4\. Receiving, or decision to commence, ECMO in the next 24 hours.
•5\. Mechanical ventilation using HFOV or APRV
•6\. Untreated pulmonary embolism, pleural effusion or pneumothorax as the primary cause of acute respiratory failure.
•7\. Acute respiratory failure fully explained by left ventricular failure or fluid overload (May be determined by clinical assessment or echocardiography/cardiac output monitoring).
•8\. Left ventricular failure requiring mechanical support
•9\. Contra\-indication to limited systemic anticoagulation with heparin