Continuous monitoring of body electric signals in Paediatric Intensive Care

ISRCTN	ISRCTN71463496
DOI	https://doi.org/10.1186/ISRCTN71463496
IRAS number	157604
Secondary identifying numbers	IRAS project ID 157604

Submission date: 04/08/2015
Registration date: 14/08/2015
Last edited: 15/12/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Balazs Fule
Scientific

Birmingham Children's Hospital
PICU Research Office
Steelhouse Lane
Birmingham
B4 6NH
United Kingdom

Phone	+44 121 333 9850
Email	balazs.fule@bch.nhs.uk

Study information

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
Participant information sheet	Not available in web format, please use the contatct details below to request a Patient Information Sheet
Scientific title	Feasibility of continuous surface electro-gastrography (sEGG) and surface electro-myography (sEMG) monitoring in Paediatric Intensive Care
Study acronym	ExG
Study objectives	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
Health condition(s) or problem(s) studied	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
Completion date	30/06/2017

Eligibility

Participant type(s)	Patient
Age group	Child
Upper age limit	16 Years
Sex	Both
Target number of participants	5
Key inclusion criteria	1. Paediatric ICU patients with spontaneous breathing activity 2. Age between term and 16 years
Key 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)
Date of first enrolment	23/06/2015
Date of final enrolment	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

Birmingham Children's Hospital R&D Department
Hospital/treatment centre

Birmingham Children's Hospital
Steelhouse Lane
Birmingham
B4 6NH
England
United Kingdom

"ROR"	https://ror.org/017k80q27

Funders

Funder type

Birmingham Children's Hospital

No information available

Inbiolab BV

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
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.
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
HRA research summary			28/06/2023	No	No

Editorial Notes

15/12/2016: The overall trial end date has been updated from 31/12/2015 to 30/06/2017.