Non-invasive measurement of cerebral energy status: an opportunity to target neuroprotection in brain injury

ISRCTN	ISRCTN84669284
DOI	https://doi.org/10.1186/ISRCTN84669284
Protocol serial number	5789
Sponsor	University College London Hospitals NHS Foundation Trust (UK)
Funders	Engineering and Physical Sciences Research Council (EPSRC) (UK), Medical Research Council (MRC) (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Martin Smith
Scientific

National Hospital for Neurology & Neurosurgery
Box 30
London
WC1N 3BG
United Kingdom

Primary study design	Observational
Study design	Single centre non-randomised process of care trial
Secondary study design	Single-centre
Scientific title
Study acronym	Non-invasive measurement of cerebral energy status
Study objectives	We will use a combination of near infrared spectroscopy systems to assess non-invasively cerebral oxygenation, perfusion and cellular metabolic status in healthy volunteers and critically brain injured adults in order to monitor and quantify cerebral ischaemia in the latter. Specifically we will non-invasively measure changes in cell energy status by monitoring concentration changes in cytochrome oxidase (ox-CCO) using a novel hybrid optical spectroscopy system optimised for the measurement of ox-CCO in adults.
Ethics approval(s)	MREC approved (ref: 04/Q0512/67)
Health condition(s) or problem(s) studied	Topic: Neurological; Subtopic: Neurological (all Subtopics); Disease: Nervous system disorders
Intervention	Volunteer studies: Hyperoxia, hypoxia, hypercapnea and hypocapnea Patient studies: NIRS-derived changes in cerebral oxygenation, haemodynamics and oxidised cytochorme c oxidase concentrations, and cerebral microdialysis-derived markers of ischaemia (lactate:pyruvate ratio and glucose). Study entry: registration only
Intervention type	Other
Primary outcome measure(s)	Infrared specotrscopy
Key secondary outcome measure(s)	Estimated cerebal oxygen delivery
Completion date	31/12/2011

Participant type(s)	Healthy volunteer
Age group	Adult
Lower age limit	18 Years
Sex
Target sample size at registration	170
Key inclusion criteria	1. Healthy volunteers and patients with severe traumatic brain injury 2. Male and female, lower age limit of 18 years
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/2006
Date of final enrolment	31/12/2011

National Hospital for Neurology & Neurosurgery

London
WC1N 3BG
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2008		Yes	No