Plain English Summary
Background and study aims
In the UK, more than 1.5 million children are admitted to hospital every year, 4,500 of which will require treatment in intensive care. Serious illness can have a big impact on the digestive system and the workload of the muscles involved in breathing (respiratory muscles). Scanning techniques designed to detect electrical activity in the muscles below the skin, such as surface electrogastrography (sEGG) and surface electromyography (sEMG), can help to provide healthcare professionals with more useful information about how these bodily functions are performing than routine testing, which can improve patient care.
These techniques have only been used for short periods of time in the past, however recent improvements in technology mean that they could potentially be used for longer.
This study aims to find out whether these techniques can be used for continuous monitoring of children in paediatric intensive care to provide ongoing information about the digestive system and respiratory muscles.
Who can participate?
Children in intensive care who are able to breathe unaided
What does the study involve?
Eight surface electrode sensors are applied to the bodies of participants. These electrodes are then attached to a special amplifier which in turn is connected to a laptop, which will convert the raw signals into data which can be analyzed.
What are the possible benefits and risks of participating?
There will be no direct benefits or risks to patients participating in this study.
Where is the study run from?
Brimingham Children’s Hospital (UK)
When is the study starting and how long is it expected to run for?
February 2014 to December 2015
Who is funding the study?
1. Birmingham Children's Hospital (UK)
2. Inbiolab BV (UK)
Who is the main contact?
Dr Balazs Fule
balazs.fule@bch.nhs.uk
Study website
Contact information
Type
Scientific
Contact name
Dr Balazs Fule
ORCID ID
Contact details
Birmingham Children's Hospital
PICU Research Office
Steelhouse Lane
Birmingham
B4 6NH
United Kingdom
+44 121 333 9850
balazs.fule@bch.nhs.uk
Additional identifiers
EudraCT/CTIS number
IRAS number
157604
ClinicalTrials.gov number
Protocol/serial number
IRAS project ID 157604
Study information
Scientific title
Feasibility of continuous surface electro-gastrography (sEGG) and surface electro-myography (sEMG) monitoring in Paediatric Intensive Care
Acronym
ExG
Study hypothesis
This study is a pilot to establish that we can collect continuous sEGG and sEMG data in the settings of paediatric intensive care.
Ethics approval(s)
National Research Ethics Service Committee West Midlands, 01/12/2014, ref: 14/WM/1221
Study design
Observational single-center feasibility medical device study within CE marked intended use
Primary study design
Observational
Secondary study design
Case series
Study setting(s)
Hospital
Study type
Not Specified
Patient information sheet
Not available in web format, please use the contatct details below to request a Patient Information Sheet
Condition
Testing continuous surface electro-gastrography (sEGG) and surface electro-myography (sEMG)
Intervention
Acquisuition of surface biopotentials (such as ECG, electromyography and electrogastrography signals) from a set of (8) surface electrodes over a period of 48 hours.
Intervention type
Device
Pharmaceutical study type(s)
Phase
Drug/device/biological/vaccine name(s)
Primary outcome measure
Feasibility of continuously monitoring ECG, EGG and EMG signals at the same time. Measurements taken at baseline and then at every hour of data collection.
Secondary outcome measures
To identify potential noises that may distort data quality. The presence of electric signals will be decided by expert opinion to provide data quality and quantity measures.
Overall study start date
01/02/2014
Overall study end date
30/06/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Paediatric ICU patients with spontaneous breathing activity
2. Age between term and 16 years
Participant type(s)
Patient
Age group
Child
Upper age limit
16 Years
Sex
Both
Target number of participants
5
Participant exclusion criteria
1. Preterm infants
2. Muscle relaxant infusion at enrollment
3. Open abdomen after abdominal surgery
4. Open skin after sternotomy
5. Burns affecting the torso
6. Skin conditions (limiting use of ECG sensors)
Recruitment start date
23/06/2015
Recruitment end date
01/10/2015
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
Birmingham Children's Hospital
Steelhouse Lane
Birmingham
B4 6NH
United Kingdom
Sponsor information
Organisation
Birmingham Children's Hospital R&D Department
Sponsor details
Birmingham Children's Hospital
Steelhouse Lane
Birmingham
B4 6NH
England
United Kingdom
Sponsor type
Hospital/treatment centre
Website
ROR
Funders
Funder type
Funder name
Birmingham Children's Hospital
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Inbiolab BV
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
As this is a small feasibility study, we are not planning to publish the results in a Journal. We will assess the results (quantity and quality of recorded signals) within our team and may present them on scientific conferences during 2016-2017. You may read the results on the hospital website (www.bch.nhs.uk) or you can e-mail us on PICU.team@bch.nhs.uk.
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |