NIRS to monitor peripheral tissue oxygenation in IABP & pVA ECMO
Research type
Research Study
Full title
The use of near infrared spectroscopy (NIRS) to monitor peripheral tissue oxygenation in patients treated with peripheral venous-arterial extracorporeal membrane oxygenation (pVA ECMO) and intra-aortic balloon pump (IABP)
IRAS ID
324758
Contact name
Alain Vuylsteke
Contact email
Sponsor organisation
Royal Papworth NHS foundation trust
Duration of Study in the UK
0 years, 9 months, 1 days
Research summary
Intra-aortic balloon pumps (IABP) and peripheral venous arterial extracorporeal membrane oxygenation (pVA ECMO) are mechanical circulatory support devices used to treat critically ill patients at Royal Papworth Hospital (RPH). Both devices involve the insertion of a large cannula into an artery in the upper leg, which may cause reduced blood flow to the lower leg. If left undetected, this can lead to permanent damage and even loss of limb.
Clinical observations of the cannulated leg to assess for signs of poor blood flow are currently performed by clinicians. However, these are completed hourly which carrys the risk of changes in blood flow going undetected. Near-infrared spectroscopy (NIRS) is a non-invasive monitoring system currently used at RPH on critically ill patients to measure blood flow to the brain. This device measures regional oxygenation (rSO2) a surrogate of oxygenated blood.
The primary aim of this study is to introduce NIRS as a continuous method of measuring blood flow to the lower leg in individuals treated with pVA ECMO and IABP to assess whether it can detect poor blood flow to the leg earlier than current methods. Patients will be connected to NIRS via adhesive electrodes placed on the calf muscles of each leg once referred for support from IABP or pVA ECMO. rSO2 measurements will be documents at baseline (prior to insertion of cannula), immediately post insertion, and then continuously every hour until taken off the device or care is withdrawn. Should rSO2 readings fall <40% or a >25% decrease in reading from baseline the bedside nurse will perform a clinical examination.
A secondary aim of the study is to assess the impact the NIRS monitoring system has on the clinical staff which will be assessed via a self-report questionnaire completed by the bedside nurse at the end of their shift.
REC name
East of England - Essex Research Ethics Committee
REC reference
23/EE/0140
Date of REC Opinion
24 Aug 2023
REC opinion
Further Information Favourable Opinion