Sepsis, Shock, Surgery
Conditions
Brief summary
The extent and duration of tissue hypoxia is a major determinant of outcome following major, high-risk surgery and in critical illness. Prompt restoration of tissue oxygenation through resuscitation in all likelihood improves outcomes. There are currently no bedside monitors in clinical practice that track tissue perfusion per se, instead clinicians rely on crude surrogates such as heart rate and blood pressure, urine output, serum lactate of global flow (cardiac output) monitoring. This is a first-in-man trial of a new device to measure tissue oxygenation in real time in a major, high-risk surgical and critical care cohort. The device consists of an oxygen sensing probe incorporated into a modified urinary catheter, which relies on photoluminescence technology and the quenching properties of oxygen. Once inserted, the drained bladder collapses round and envelopes the probe which continuously measures tissue oxygenation of the bladder urothelium. The investigators hope to (i) Establish that tissue oxygenation can be safely monitored using this technology, deployed in this way. (ii) Define a normal range for bladder tissue oxygenation in man as measured using this device. (iii) Compare tissue oxygenation against other markers of perfusion status in current clinical practice and assess its performance at detecting inadequate perfusion against these other modalities. (iv) assess the diagnostic and prognostic capabilities of the tissue oxygenation monitoring at detecting hypo-perfusion and predicting outcome. (v) Further assess the tissue response to an 'oxygen challenge' in identifying occult hypo-perfusion. (vi). Provide pilot work required to inform future, interventional studies where similar patients would be resuscitated to tissue oxygenation targets alongside routine clinical practice.
Detailed description
As above
Interventions
DEVICEWellBeing catheter
Urethral catheterisation with integral Wellbeing Catheter to measure bladder tissue oxygen tension
Sponsors
Wellcome Trust
Department of Health, United Kingdom
University College London Hospitals
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* having major elective or emergency surgery (deemed to need invasive BP monitoring by anaesthetist) and a urinary catheter * OR emergency admission to critical care (necessitating arterial line and urinary catheter).
Exclusion criteria
* age \<18 * pregnancy * contraindication to arterial cannulation or urethral catheterisation * surgery on lower urinary tract/bladder * patient refusal
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to identification of a low bladder tissue PO2 versus time to development of hyperlactatemia (2 mmol/l) | Up to 7 days | Comparison of bladder tissue PO2 values (normal range to be defined as part of this first-in-man study) against lactate values \>2 mmol/l |
| Time to identification of a low bladder tissue PO2 versus time to development of hypotension (mean BP <60 mmHg) | Up to 7 days | Comparison of bladder tissue PO2 values (normal range to be defined as part of this first-in-man study) against mean BP values \<60 mmHg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Device-Related Adverse Events | Up to 28 days | Monitoring of direct device-related complications (e.g. bleeding, bladder perforation) |
| Identification of future complications in postoperative patients | Up to 7 days | Low bladder tissue PO2 values identify postoperative complications using POMS-score-defined morbidity at Days 3 and 7 |
Countries
United Kingdom
Contacts
Primary ContactMervyn Singer, MB BS
Backup ContactDavid Brealey, MB BS
Outcome results
None listed