A new way of treating patients with respiratory failure

Not Applicable

Completed

• Conditions: Acute hypoxaemic respiratory failure; Respiratory

• Registration Number: ISRCTN31262122
• Lead Sponsor: Belfast Health & Social Care Trust

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-14
• Study Completion: 2022-04-30
• Last Update Posted: 30 October 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 412

Inclusion Criteria

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).

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified