Manchester University NHS Foundation Trust (MFT) has been awarded almost £2.5m to investigate the effectiveness of new airways devices to transform care and outcomes for seriously ill patients in hospital Intensive Care Units (ICUs) who need help to breathe.
Funded by the National Institute for Health and Care Research (NIHR), the six-year, MFT-led “PROTECT Airways*” study will investigate if new advanced airway protection systems, that connect critically ill patients to breathing machines (ventilators), will reduce serious side effects and shorten the duration of ICU care.
Dr Gareth Kitchen, Honorary MFT Consultant Anaesthetist, Clinical Senior Lecturer at The University of Manchester, and Co-chief Investigator said: “We are delighted to be awarded this funding from the NIHR. As clinicians we want to ensure that the most poorly patients in our care have the best chance of recovery. This important research will help us to understand if new advanced airway protection systems can improve patient outcomes and are more effective than the systems currently used in NHS care.”
Annually, approximately 184,000 patients are admitted to NHS ICUs – specialist hospital wards that provide treatment and monitoring for people who are seriously ill. 33 per cent of people admitted to the ICU need a machine to help them breathe. Treatment involves placing a plastic tube through the mouth into the windpipe and attaching the person to a ventilator. By doing this, the machine takes over the breathing for the patient.
A serious complication of this life-saving treatment is ventilator associated pneumonia (VAP) which affects 20 per cent of people on breathing machines (approximately 12,200 patients per year).
It occurs when infected mucus drips down the back of the throat past the plastic tube into the lungs. Whilst VAP can be treated with antibiotics, some people will die and others will spend much longer on a breathing machine in ICU, as a result.
In addition to the health risks to the patients, there are also significant healthcare costs associated with a prolonged stay on ICU, with each day of care costing approximately £1,500.
Professor Paul Dark, Honorary MFT Research Consultant, Chair in Critical Care Medicine – The University of Manchester, NHS Consultant in Critical Care – Northern Care Alliance NHS Foundation Trust, and Co-chief Investigator said: “Previous patient studies suggest new advanced airway protection systems are safe, with improved seals which prevent the risk of infective mucus passing down into the lung and causing infection.
“However, although some hospitals are using the new advanced airway protection systems we do not know if the positive findings seen in a few hospitals would also be seen in the wider NHS. This is why The National Institute for Health and Care Excellence (NICE) has recommended a large-scale research study to evaluate the clinical and cost-effectiveness of these advanced airway devices in the NHS.”
44 NHS ICUs across England will recruit a target of 2,194 adult patients, to the study. The ICUs at Manchester Royal Infirmary (MRI), North Manchester General Hospital (NMGH) and Wythenshawe Hospital, all part of MFT, will be study sites, set to recruit from September 2024.
Dr Kitchen added: “We believe this study will provide definitive evidence for the most effective airways protection device for patients who require mechanical ventilation and will define future NHS and international practice.”
The University of Warwick’s Clinical Trials Unit (WCTU), based at Warwick Medical School, will co-ordinate trial delivery, in collaboration with MFT.
Critically ill patients receiving NHS care will be randomly assigned to one of two groups; one group will receive an advanced airway system and the other group will receive the standard treatment in that hospital. Patients will have an equal chance to receive either treatment.
The study will compare how long patients spend on a ventilator and if they develop VAP. The researchers will measure patient survival, quality of life and the use of NHS resources during hospital stay and recovery.
- *Full title: The clinical and cost effectiveness of advanced airways protection device versus conventional endotracheal tubes in Intensive care unit patients requiring mechanical ventilation: a multi-centre, pragmatic randomised clinical trial (PROTECT Airways) study.