Condition category
Not Applicable
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status
Results overdue

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

Trial website

Contact information



Primary contact

Dr Balazs Fule


Contact details

Birmingham Children's Hospital
PICU Research Office
Steelhouse Lane
B4 6NH
United Kingdom
+44 121 333 9850

Additional identifiers

EudraCT number 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



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

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


Secondary study design

Case series

Trial setting


Trial type

Not Specified

Patient information sheet

Not available in web format, please use the contatct details below to request a Patient Information Sheet


Testing continuous surface electro-gastrography (sEGG) and surface electro-myography (sEMG)


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



Drug names

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 trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Paediatric ICU patients with spontaneous breathing activity
2. Age between term and 16 years

Participant type


Age group




Target number of participants


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


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information


Birmingham Children's Hospital R&D Department

Sponsor details

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

Sponsor type

Hospital/treatment centre



Funder type

Funder name

Birmingham Children's Hospital

Alternative name(s)

Funding Body Type

Funding Body Subtype


Funder name

Inbiolab BV

Alternative name(s)

Funding Body Type

Funding Body Subtype


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 ( or you can e-mail us on

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

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