Continuous monitoring of body electric signals in Paediatric Intensive Care
| ISRCTN | ISRCTN71463496 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71463496 |
| Integrated Research Application System (IRAS) | 157604 |
| Protocol serial number | IRAS project ID 157604 |
| Sponsor | Birmingham Children's Hospital R&D Department |
| Funders | Birmingham Children's Hospital, Inbiolab BV |
- 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
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
Scientific
Birmingham Children's Hospital
PICU Research Office
Steelhouse Lane
Birmingham
B4 6NH
United Kingdom
| Phone | +44 121 333 9850 |
|---|---|
| balazs.fule@bch.nhs.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational single-center feasibility medical device study within CE marked intended use |
| Secondary study design | Case series |
| Study type | Participant 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 |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
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. |
| Completion date | 30/06/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Upper age limit | 16 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Birmingham
B4 6NH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
15/12/2016: The overall trial end date has been updated from 31/12/2015 to 30/06/2017.
