Oxygen delivery during sedation for transcatheter valve implantation
Research type
Research Study
Full title
A randomised controlled trial of high-flow nasal oxygen (HFNO) vs. standard oxygen therapy in patients undergoing transfemoral transcatheter aortic valve implantation (TAVI) under conscious sedation.
IRAS ID
255651
Contact name
Andrew A Klein
Contact email
Sponsor organisation
Royal Papworth Hospital NHS Foundation Trust
ISRCTN Number
ISRCTN13804861
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
We are investigating whether high flow nasal oxygen (HFNO) in patients undergoing transcatheter aortic valve implantation (TAVI) under concious sedation compared to standard oxygen delivery (2l/min oxygen by dry nasal specs) improves gas exchange and cardiovascular parameters. The treatment for aortic stenosis is aortic valve replacement, which has traditionally required sternotomy and cardiopulmonary bypass. TAVI is increasingly used as surgery is not required and the patient may be able to go home and recover much quicker. Previous studies have shown that conscious sedation is associated with reduced procedural time, and complications, and further reduced hospital stay . However, some patients develop hypoxia during conscious sedation, especially as they have to lie flat for the procedure (60-120 minutes). This is a particular problem in patients with pre-existing lung disease or cardiac failure (pulmo-nary oedema), obese patients, and patients who are anxious and require deeper levels of sedation. In our study we will use a cannula to deliver oxygen in a form of therapy that provides a respiratory support with an air/oxygen blender, active humidifier, single heated tube, and a nasal cannula. The system delivers adequately heated and humidified medical gas at flows up to 70 L/min, furthermore it is considered to have a number of physiological advantages compared with other standard oxygen therapies. This includes reduced anatomical dead space, increased comfort and improved gas exchange. We will randomly allocate patient to receive high-flow nasal oxygen or standard of care oxygen while they are sedated for the TAVI procedure, and will observe them closely to see how they are in terms of breathing and gas exchange while they are sedated, and how quickly and well they recover afterwards
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
19/EE/0104
Date of REC Opinion
28 Mar 2019
REC opinion
Further Information Favourable Opinion