Surrogate of Adequate Perfusion: Bladder tissue OXygen monitoring
Research type
Research Study
Full title
An observational study of tissue oxygen monitoring for detecting impending shock states in the critically ill and those undergoing high risk surgery (SoAPBOx)
IRAS ID
245484
Contact name
Mervyn Singer
Contact email
Sponsor organisation
Oxford Optronix Ltd
Duration of Study in the UK
1 years, 5 months, 5 days
Research summary
Complications frequently occur following trauma, infection and major surgery. This can lead to failure of vital organs (e.g. lung, kidney, gut) necessitating admission to intensive care for organ support. Mortality rates are high and long-term disability common in survivors. Studies show how early resuscitation of the circulation in these patients can considerably improve outcomes. We can currently gauge how much blood the heart is pumping to the tissues. However, we need better bedside monitors to assess if this cardiac output is actually adequate for the organs. Patients who are unwell or undergoing major surgery routinely have a bladder (Foley) catheter placed to drain urine. We can use this catheter to insert a small, flexible fibre-optic based sensor to continuously monitor oxygen levels in the bladder wall. This indicates whether or not the local blood supply (perfusion) is adequate and can reflect the situation in other parts of the body. We plan to study whether this offers an easy and readily applicable solution to monitoring tissue health during acute illness or surgical insults. If so, we plan to proceed to perform a clinical investigation at a later date in which the circulation is optimized with this device to see if such complications can be significantly reduced, and patient outcomes and hospital costs are improved.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
18/EE/0242
Date of REC Opinion
12 Oct 2018
REC opinion
Further Information Favourable Opinion