Surrogate of Adequate Perfusion: Bladder Tissue Oxygen Monitoring

NCT03935477 | Unknown DMC

• 1 other identifier: CIP_DPW016_OBS
• Study Type: observational
• Target: 315
• Locations: 1 country
• Sites: 1

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.

Conditions

Shock; Sepsis; Surgery

Outcome Measures

Primary Outcomes (2)

• 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

  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

  Up to 7 days

Secondary Outcomes (2)

• Number of Participants With Device-Related Adverse Events

  Up to 28 days

• Identification of future complications in postoperative patients

  Up to 7 days

Study Arms (2)

High risk surgery

those undergoing elective and emergency, high-risk surgery receiving arterial cannulation and urethral catheterisation as standard

Device: WellBeing catheter

Critical Care

Emergency admissions to UCLH critical care unit receiving arterial cannulation and urethral catheterisation as standard

Device: WellBeing catheter

Interventions

WellBeing catheter DEVICE

Urethral catheterisation with integral Wellbeing Catheter to measure bladder tissue oxygen tension

Critical Care; High risk surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

as described above

You may qualify if:

• 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).

You may not qualify if:

• age \<18
• pregnancy
• contraindication to arterial cannulation or urethral catheterisation
• surgery on lower urinary tract/bladder
• patient refusal

Sponsors & Collaborators

• University College London Hospitals: lead
• Wellcome Trust: collaborator
• Department of Health, United Kingdom: collaborator

Study Sites (1)

UCL Hospitals NHS Foundation Trust

London, NW1, United Kingdom

RECRUITING

MeSH Terms

Conditions

Shock; Sepsis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections; Systemic Inflammatory Response Syndrome; Inflammation

Study Officials

• Mervyn Singer, MD

  UCL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mervyn Singer, MB BS

CONTACT

+44-207-679-6714; m.singer@ucl.ac.uk

David Brealey, MB BS

CONTACT

d.brealey@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: March 13, 2019
• First Posted: May 2, 2019
• Study Start: April 10, 2019
• Primary Completion: February 1, 2020
• Study Completion: March 1, 2020
• Last Updated: May 2, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)