Contact information
Type
Scientific
Primary contact
Prof Hugh McCann
ORCID ID
Contact details
School of Electrical & Electronic Engineering
University of Manchester
PO Box 88
Sackville Street
Manchester
M60 1QD
United Kingdom
+44 (0)161 306 4791
h.mccann@manchester.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
077724; NRES:07/H1003/H145/CMFT:9644
Study information
Scientific title
Real-time functional brain imaging using Electrical Impedance Tomography of Evoked Responses: two stage volunteer safety and patient randomised crossover trial
Acronym
fEITER
Study hypothesis
Functional brain imaging using positron emission tomography has shown that general anaesthesia reduces brain function in a dose-related manner. It is hypothesised that fEITER will derive similar images of human brain function arising from the normal changes in synaptic impedance that occur during cerebral processing of sensory information, but much faster than existing scanning methods and with a suitcase-sized device. We expect fEITER to visualise the reduction in cerebral sensory processing during anaesthesia, and this study will allow the preparation of a dose-response curve indicating the level of anaesthesia with fEITER. Deep surgical anaesthesia has a maximal effect on reducing brain metabolism, so such measurement will permit calibration of the 100% level for sensitivity of fEITER. The null hypothesis is that fEITER will visualise no effect of anaesthesia on brain function.
As of 05/10/2010 the initial end date of this trial has been extended by the funders, the Wellcome Trust. The initial end date at time of registration was 30/09/2010. Stage 1 healthy volunteers is completed (n = 20) and stage 2 patients is recruiting with n = 4 to date.
Ethics approval
South Manchester Research Ethics Committee approved on the 30th January 2008 (ref: 07/H1003/H145). Confirmation of continued favourable opinion was given on 11th August 2009.
Study design
Two stages:
1. Volunteer safety trial
2. Patient randomised blinded crossover trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Brain function during anaesthesia
Intervention
For both stages 1 and 2, 32 electroencephalogram (EEG) electrodes will be affixed to the scalp at the beginning of the trial (10 minutes). For stage 1 (healthy volunteers), a one-hour trial of fEITER will proceed, comprising sequential one-minute presentations of auditory (click and tone) and visual (flash) sensory stimuli presented in a random sequence during fEITER tomograpic measurements of brain function in response to the sensory stimuli. For stage 2 (anaesthetised patients), an awake tolerance test of two, one-minute presentations of visual and auditory stimuli will be tested with fEITER (control) and then repeated, sequential one-minute tests of fEITER will be conducted during anaesthesia and surgery. The randomisation and crossover will be in the depth of anaesthesia used (concentration of anaesthetic agent) within normal clinical ranges. Depth of anaesthesia will be assessed before and after each one-minute fEITER test using a commercial depth of anaesthesia monitor (Bispectral Index). The total duration for stage 2 will be the length of surgery, which is variable.
Please note that as of 26/05/10 the end date of this trial has been extended from 30/06/10 to 30/09/10
Intervention type
Procedure/Surgery
Phase
Not Applicable
Drug names
Primary outcome measure
Production of functional brain images that discriminate between different depths of anaesthesia and awake subjects, assessed continuously during the fEITER trial using 1-minute epochs of cerebral conductance data obtained every 10 ms, and determined by off-line analysis, including 3D functional brain image reconstruction, after the trial.
Secondary outcome measures
No secondary outcome measures
Overall trial start date
16/11/2009
Overall trial end date
30/04/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Stage 1:
1. Healthy volunteers
2. Aged 18 to 80 years, gender: female, trans or male
Stage 2:
1. American Society of Anaesthesiologists (ASA) grade I - II
2. Adult patients aged 18 to 80 years, gender: female, trans or male
3. Scheduled for elective surgery under routine general anaesthesia
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
20 healthy volunteers; 20 patients
Participant exclusion criteria
Stages 1 and 2:
History of epilepsy or neurological impairment
Recruitment start date
16/11/2009
Recruitment end date
30/04/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
School of Electrical & Electronic Engineering
Manchester
M60 1QD
United Kingdom
Sponsor information
Organisation
University of Manchester (UK)
Sponsor details
Oxford Road
Manchester
M13 9WL
United Kingdom
+44 (0)161 276 8582
chris.pomfrett@manchester.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Wellcome Trust (UK) - University Translation Award (grant ref: 077724)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
Basic results (scientific)
Publication list
2011 results: http://journals.lww.com/ejanaesthesiology/Fulltext/2011/06001/Functional_electrical_impedance_tomography_by.311.aspx