Condition category
Injury, Occupational Diseases, Poisoning
Date applied
12/05/2010
Date assigned
12/05/2010
Last edited
12/05/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Martin Smith

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

5789

Study information

Scientific title

Acronym

Non-invasive measurement of cerebral energy status

Study hypothesis

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

MREC approved (ref: 04/Q0512/67)

Study design

Single centre non-randomised process of care trial

Primary study design

Observational

Secondary study design

Single-centre

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

Infrared specotrscopy

Secondary outcome measures

Estimated cerebal oxygen delivery

Overall trial start date

01/01/2006

Overall trial end date

31/12/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Healthy volunteers and patients with severe traumatic brain injury
2. Male and female, lower age limit of 18 years

Participant type

Healthy volunteer

Age group

Adult

Gender

Not Specified

Target number of participants

Planned sample size: 170

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/2006

Recruitment end date

31/12/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

University College London Hospitals NHS Foundation Trust (UK)

Sponsor details

Research and Development Directorate
250 Euston Road
London
NW1 2PG
United Kingdom

Sponsor type

Government

Website

http://www.uclh.nhs.uk/

Funders

Funder type

Research council

Funder name

Engineering and Physical Sciences Research Council (EPSRC) (UK)

Alternative name(s)

EPSRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18290332

Publication citations

  1. Results

    Tisdall MM, Tachtsidis I, Leung TS, Elwell CE, Smith M, Changes in the attenuation of near infrared spectra by the healthy adult brain during hypoxaemia cannot be accounted for solely by changes in the concentrations of oxy- and deoxy-haemoglobin., Adv. Exp. Med. Biol., 2008, 614, 217-225, doi: 10.1007/978-0-387-74911-2_25.

Additional files

Editorial Notes