Neonatal Respiratory Distress
Conditions
Keywords
Electrical impedance tomography, neonate
Brief summary
The usability of a new PNEUMACRIT system is studied in clinical environment in this feasibility study.
Detailed description
Electrical impedance tomography is a noninvasive monitoring tool for neonatal lung aeration and breathing. This feasibility study will assess the usability of a new PNEUMACRIT electrode belt in clinical environment.
Interventions
DEVICEPNEUMACRIT
Monitoring of breathing
Sponsors
Middlesex University
University of Oulu
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
The device feasibility will be assessed in clinical environment with feedback from both the patient parents and nurses in NICU/PICU.
Eligibility
Sex/Gender
ALL
Age
12 Hours to 6 Months
Healthy volunteers
No
Inclusion criteria
* Inpatient at Oulu University Hospital PICU or NICU * Gestational age at birth over 32 weeks * Weight 2000-5000g * Postnatal age \> 12 hours * Written informed consent from the parents of legal representative * Non-invasive monitoring of oxygen saturation and ECG
Exclusion criteria
* Postmenstrual age \< 32 weeks * Weight at time of the study \< 2000g or \> 5000g * Chest skin lesion preventing safe use of the electrode belt * Recent chest surgery within the past 7 days (e.g. thoracotomy)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion (%) of recording time with high quality EIT-signal | 6-24 hours | Proportion of time that the collected EIT signal is accurate enough for reliable image reconstruction and observations of changes in lung aeration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Staff and parent questionnaires | 48 hours | After the study period, the patient parents and nurses will give feedback on the device and its feasibility with a structured questionnaire including also free text fields |
Countries
Finland
Outcome results
None listed