REST Trial Rest logo

Trial Acronym REST Trial
Clinical Area Critical care
Description A pragmatic randomised controlled trial to determine whether Extracorporeal Carbon Dioxide Removal (VV-ECCO2R) and lower tidal volume mechanical ventilation in patients with hypoxaemic respiratory failure improves 90 day mortality
Status Open
RECRUITMENT

Recruitment duration 01st June 2016 = 30th April 2020 (dependant on internal pilot)
Target Recruitment 1120
TRIAL DESIGN
Trial Design Randomised, allocation concealed, controlled, open, pragmatic clinical and cost effectiveness trial.
Study Aim To deliver a multi-centre clinical trial to determine whether VV-ECCO2R and lower tidal volume mechanical ventilation improves outcomes and is cost-effective, in comparison with standard care in patients who are mechanically ventilated for acute hypoxaemic respiratory failure.
CHIEF INVESTIGATOR (CI)
Chief Investigator Prof Danny McAuley
SPONSOR(s) & FUNDER(s)
Sponsor Belfast Health and Social Care Trust
Funder National Institute for Health Research
PATIENT INFORMATION
Lay Summary Many patients admitted to the Intensive Care Unit (ICU) need a breathing machine, or ventilator, to help them breathe and ensure that enough oxygen gets into their blood and carbon dioxide is removed. For reasons that are unclear, when people are critically ill their lungs often fail, this is termed acute respiratory failure. Currently, there are no specific treatments other than placing the person on a ventilator to help bellow air in and out of the lungs. In light of this we are investigating a treatment for acute respiratory (lung) failure.

Studies have suggested that although ventilation is a life-saving intervention it may damage the lungs and prevent healing and repair. This is especially so when ventilation requires excessive pressure and volume to ensure enough oxygen is provided and carbon dioxide is removed. There is currently a device called extracorporeal carbon dioxide removal (ECCO2R), which is similar to kidney dialysis that can remove carbon dioxide from the blood. This device is used in the UK sometimes and has the potential to assist ventilation and allow ventilation pressure and volume to be reduced. We will determine if there is a greater chance of patient’s survival by applying ECCO2R and using more protective ventilation. We will also look at whether ECCO2R reduces the time patients spend on a ventilator and in hospital and also the quality of life and condition of the lungs when the patient is discharged.

We think that treating patients early in this situation with protective ventilation helps them to recover so we need to include patients to the study within 48 hours of becoming unwell in ICU. To assess the role of ECCO2R we will be recruiting 1120 patients from ICUs.
This is a randomised trial where the patient will be allocated to either ECCO2R or standard care (without ECCO2R).