PROTECTION: a pilot randomised controlled trial
Research type
Research Study
Full title
PRessure suppOrT vEntilation + Sigh in aCuTe hypoxemIc respiratOry failure patieNts (PROTECTION): a pilot randomized controlled trial
IRAS ID
227924
Contact name
Tomas Jovaisa
Contact email
Sponsor organisation
Barking, Havering and Redbridge University Hospitals NHS Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 4 months, 1 days
Research summary
Patients who have acute hypoxemic respiratory failure (AHRF) and acute respiratory distress syndrome (ARDS) and require support with a breathing machine have a high chance of dying (around 40%). The main factors that influence this are how severe any injury to their lungs is initially, and whether they receive appropriate treatment early. Additionally, while the lungs recover, further injury by the breathing machine might significantly impact survival.
Recent studies testing strategies that enhance lung protection showed ways to significantly decrease mortality. However, such trials included only the most severely unwell patients on breathing machines.
It is known that there are patients who do not fit into the category of the ‘severely unwell’ included in the trials mentioned above, and in whom the method of using the breathing machine used for those patients cannot be used (because they are less deeply sedated, and may be trying to breathe on their own, which is beneficial), but are also at risk of lung damage. Thus, early implementation of a mechanical ventilation mode that enhances lung protection in these patients may have an impact on clinical practice.
To this end, previous studies showed that a particular way of using the breathing machine improves oxygenation of blood without increasing the pressure needed to open the lung, and with additional less oxygen required, as well as other factors that could reduce injury to patients lungs.
Therefore, we designed a study protocol for a large randomized controlled trial (RCT) to test the impact of early application of this method on long-term clinical outcomes of mild to moderate AHRF and ARDS patients undergoing spontaneous breathing, compared to protective Pressure Support Ventilation (PSV) alone. However, there are no prospective clinical trials including long-term use of PSV+Sigh. Thus, we first conceived a pilot RCT to verify clinical feasibility.
REC name
Wales REC 7
REC reference
19/WA/0012
Date of REC Opinion
23 Jan 2019
REC opinion
Favourable Opinion