ISRCTN31262122已完成未知
PRotective vEntilation with veno-venouS lung assisT in respiratory failure
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 412
研究概览
简要总结
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)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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).
排除标准
- •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
- •10. Unable to obtain vascular access to a central vein (internal jugular or femoral vein)
- •11. Inferior vena cava filter (if using femoral vein catheter)
- •12. Consent declined
- •13. Treatment withdrawal imminent within 24 hours
- •14. Patients not expected to survive 90 days on basis of premorbid health status
- •15. DNAR (Do Not Attempt Resuscitation) order in place (added 05/03/2019: excluding advance directives)
- •16. Severe chronic respiratory disease requiring domiciliary ventilation (except for sleep disordered breathing)
- •17. Severe chronic liver disease (Child Pugh >11)
- •18. Platelet count < 40,000 mm3 (added 05/03/2019: prior to catheter insertion)
- •19. Previously enrolled in the REST trial
- •20. Prisoners
- •Previous exclusion criteria:
- •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
- •10. Unable to obtain vascular access to a central vein (internal jugular or femoral vein)
- •11. Inferior vena cava filter (if using femoral vein catheter)
- •12. Consent declined
- •13. Treatment withdrawal imminent within 24 hours
- •14. Patients not expected to survive 6 months on basis of premorbid health status
- •15. DNAR (Do Not Attempt Resuscitation) order in place
- •16. Severe chronic respiratory disease requiring domiciliary ventilation (except for sleep disordered breathing)
- •17. Severe chronic liver disease (Child Pugh >11)
- •18. Platelet count < 40,000 mm3
- •19. Previously enrolled in the REST trial
研究者
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