|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ISRCTN |
|
Last refreshed on:
|
6 February 2017 |
|
Main ID: |
ISRCTN71463496 |
|
Date of registration:
|
14/08/2015 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Continuous monitoring of body electric signals in Paediatric Intensive Care
|
|
Scientific title:
|
Feasibility of continuous surface electro-gastrography (sEGG) and surface electro-myography (sEMG) monitoring in Paediatric Intensive Care |
|
Date of first enrolment:
|
23/06/2015 |
|
Target sample size:
|
5 |
|
Recruitment status: |
Completed |
|
URL:
|
http://isrctn.com/ISRCTN71463496 |
|
Study type:
|
Observational |
|
Study design:
|
Observational single-center feasibility medical device study within CE marked intended use
(Not Specified)
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
United Kingdom
| | | | | | | |
|
Contacts
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
|
|
Name:
|
Balazs
Fule |
|
Address:
|
Birmingham Children's Hospital
PICU Research Office
Steelhouse Lane
B4 6NH
Birmingham
United Kingdom |
|
Telephone:
|
+44 121 333 9850 |
|
Email:
|
balazs.fule@bch.nhs.uk |
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: 1. Paediatric ICU patients with spontaneous breathing activity
2. Age between term and 16 years
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)
Age minimum:
Age maximum:
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
Testing continuous surface electro-gastrography (sEGG) and surface electro-myography (sEMG)
Not Applicable
|
|
Intervention(s)
|
|
Acquisuition of surface biopotentials (such as ECG, electromyography and electrogastrography signals) from a set of (8) surface electrodes over a period of 48 hours.
|
|
Primary Outcome(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.
|
|
Secondary Outcome(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.
|
|
Secondary ID(s)
|
|
IRAS project ID 157604
|
|
Source(s) of Monetary Support
|
|
Birmingham Children's Hospital, Inbiolab BV
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|