Nasal High-Flow Oxygen Therapy After Cardiac Surgery (NOTACS) Study
Nasal High-Flow Oxygen Therapy After Cardiac Surgery (NOTACS) Study: Effect of High-Flow Nasal Therapy on Patient-Centred Outcomes in Patients at High Risk of Postoperative Pulmonary Complications After Cardiac Surgery: A Multicentre Randomised Controlled Trial.
Royal Papworth Hospital NHS Foundation Trust
Duration of Study in the UK
2 years, 9 months, 31 days
Patients with pre-existing lung conditions undergoing heart surgery are at high risk of postoperative lung complications and often require further respiratory support. High-flow nasal therapy (HFNT) provides warmed humidified oxygen and has been shown to assist breathing and improve patient recovery. HFNT is comfortable during use and may be even more comfortable than standard treatment with dry oxygen via a face mask or nasal prongs. Our group recently conducted a pilot study to investigate whether high-risk patients with certain lung conditions (asthma, chronic obstructive pulmonary disease) or a risk factor for postoperative lung complications (obesity, recent chest infections or heavy smoking) would benefit from routine administration of HFNT immediately after cardiac surgery. We showed that our research design is achievable and that when compared with standard care, the use of HFNT significantly reduced hospital length of stay (by 29%) and was associated with fewer re-admissions to the intensive care unit. In this follow-on, large multicentre study we will investigate whether HFNT should become routine in this patient group after cardiac surgery. Following discussion with trial participants it has been decided that the most relevant outcome measure, from patients’ perspective, is the number of days within the first 90 days after surgery that each patient is alive and able to reside at home (usual residence). This outcome captures more of the patient experience than length of hospital stay as it takes into account patients discharged early who are later re-admitted and patients who are discharged to another care facility after surgery instead of their usual home. We plan to recruit a minimum of 850 participants from cardiothoracic centres and randomly allocate them to HFNT or standard oxygen therapy, stratifying by centre. Participants will be followed up at 30 days and 90 days after surgery.
Yorkshire & The Humber - Leeds West Research Ethics Committee
Date of REC Opinion
24 Apr 2020