An observational study in Shock, Sepsis and Surgery, sponsored by University College London Hospitals. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-02.
Sponsored by University College London Hospitals · Observational
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.
As above
922 studies on the registry are indexed under Shock; 172 are open to participants now.
This study's planned enrollment of 315 is above the median of 93 across 355 observational studies indexed under Shock.
Browse Shock studies →University College London Hospitals is the lead sponsor of 63 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
as described above
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
those undergoing elective and emergency, high-risk surgery receiving arterial cannulation and urethral catheterisation as standard
Device: WellBeing catheter
Emergency admissions to UCLH critical care unit receiving arterial cannulation and urethral catheterisation as standard
Device: WellBeing catheter
Urethral catheterisation with integral Wellbeing Catheter to measure bladder tissue oxygen tension
Time to identification of a low bladder tissue PO2 versus time to development of hyperlactatemia (2 mmol/l)
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 frame: Up to 7 days
Time to identification of a low bladder tissue PO2 versus time to development of hypotension (mean BP <60 mmHg)
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
Time frame: Up to 7 days
Number of Participants With Device-Related Adverse Events
Monitoring of direct device-related complications (e.g. bleeding, bladder perforation)
Time frame: Up to 28 days
Identification of future complications in postoperative patients
Low bladder tissue PO2 values identify postoperative complications using POMS-score-defined morbidity at Days 3 and 7
Time frame: Up to 7 days
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2019 (actual). Primary completion is estimated for Feb 2020, 10 months after the start.
Of 175 non-industry observational studies under Shock, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 47. This study's planned 10 months is below that.
Counting every sponsor, half of 183 studies reached it within 27 months; a quarter within 11 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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University College London Hospitals